Decree No. 109/2016/ND-CP on issuing practice certificates for practitioners and operating permits for private healthcare establishments

DECREE

REGULATIONS ON ISSUING PRACTICE LICENSES FOR PROFESSIONALS AND OPERATING PERMITS FOR MEDICAL FACILITIES

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Investment Law dated November 26, 2014;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

At the proposal of the Minister of Health;

The Government issues this Decree stipulating the issuance of practice licenses for professionals and operating permits for medical facilities.a) Documents and procedures for issuing and reissuing practice licenses for professionals;

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Decree stipulates on:

b) Conditions, documents, and procedures for issuing, reissuing, and amending operating permits for medical facilities.

This Decree does not regulate the issuance of practice licenses for professionals and operating permits for medical facilities within the military.

This Decree applies to domestic agencies, organizations, and individuals, as well as foreign organizations and individuals in Vietnam (hereinafter referred to collectively as organizations and individuals) engaged in activities related to medical examination and treatment in Vietnam.

Article 2. Applicability

The person responsible for professional technical management at a medical facility is a person with a practice license as prescribed by the Law on Medical Examination and Treatment, practicing permanently at the medical facility, having a scope of professional activities consistent with the medical facility they manage, and being accountable under the law for all professional activities of the medical facility.

Article 3. Explanation of Terms

A valid copy is a copy issued from the original book or a copy certified from the original by an authorized agency or organization, or a copy signed by an individual or signed and stamped by an organization that has been compared with the original. In cases where the document is issued by a foreign organization, it must be apostilled and translated into Vietnamese, and the translation must be certified according to Vietnamese law.

A permanent employee is an individual registered to work continuously for eight hours per day during the operational period registered by the medical facility or an individual working the full time registered for operation by the medical facility, which is less than eight hours per day, in accordance with labor laws.

A part-time worker is an individual registered to work at a medical facility but does not meet the time requirement specified in Clause 3 of this Article.

ISSUANCE AND REISSUANCE OF PRACTICE LICENSES

Chapter II

DOCUMENTS AND PROCEDURES FOR ISSUANCE AND REISSUANCE OF PRACTICE LICENSES

Section 1. Article 4. Cases of Issuance and Reissuance of Practice Licenses

1. The issuance of practice licenses applies to the following cases:

a) Initial issuance of a practice license.

b) Amendment of a practice license when there is a change in the content of the practice license, including:

- Supplementing the scope of professional activities in the practice license when the professional requests additional specialized techniques outside the scope of professional activities already granted in the practice license;

- Changing the scope of professional activities in the practice license when the professional requests a change in specialized techniques outside the scope of professional activities already granted in the practice license;

- Changing the name, date of birth in the practice license.

2. The reissuance of a practice license applies to the following cases:

a) The practice license is revoked according to Clause 1, Article 29 of the Law on Medical Examination and Treatment;

b) The practice license is lost or damaged.

b) Professional practice certificate is lost or damaged.

Article 5. Documents for the first-time application for a professional practice certificate for Vietnamese citizens

1. Application form for issuing a professional practice certificate according to Model 01 Appendix I issued together with this Decree.

2. A valid copy of the relevant academic diploma corresponding to the scope of professional activities for which the professional practice certificate is requested, specifically as follows:

a) Medical diploma.

b) Bachelor's degree in medicine from a foreign country recognized by the Ministry of Education and Training as equivalent to a university degree but must be accompanied by a certificate of supplementary training in a relevant field for at least 12 months at a legitimate training institution in Vietnam according to the regulations of the Minister of Health, then it will be considered equivalent to a medical doctor's diploma and a professional practice certificate will be issued with the title of doctor;

c) Bachelor's degree in chemistry, biology, pharmacy at the university level and must be accompanied by a certificate or training completion document in medical laboratory technology for at least three months or a postgraduate diploma in clinical laboratory specialization;

d) Certificate of being a licensed traditional physician or certificate of having a family prescription or family treatment method issued by the Minister of Health or the Director of the Department of Health.

In case the above academic diplomas are lost, there must be a graduation certificate or a valid copy of the substitute graduation certificate issued by the training institution that issued the academic diploma.

3. Confirmation of practical experience according to Model 02 Appendix I issued together with this Decree or a valid copy of the relevant graduation diplomas in internal medicine doctors, specialist I doctors, specialist II doctors, except in cases of licensed traditional physicians, holders of family prescriptions, or holders of family treatment methods.

4. Health certificate issued by a medical examination and treatment facility specified in Clause 6, Article 23 and Clause 5, Article 25 of this Decree.

5. Criminal record sheet.

6. Personal resume according to Model 03 Appendix I issued together with this Decree, confirmed by the head of the unit where the applicant works if the applicant is working in a healthcare facility at the time of applying for the professional practice certificate, or personal resume confirmed by the People's Committee of the commune, ward, town where the applicant resides if the applicant does not work in any healthcare facility at the time of applying for the professional practice certificate.

7. Two color photographs measuring 4 cm x 6 cm taken against a white background within six months prior to the date of submission.

Article 6. Documents for the first-time application for a professional practice certificate for diagnosis and treatment for foreigners and overseas Vietnamese

1. Application form for issuing a professional practice certificate according to Model 04 Appendix I issued together with this Decree.

2. A valid copy of the relevant medical academic diploma corresponding to the professions stipulated in Article 17 of the Law on Diagnosis and Treatment.

3. Confirmation of practical experience:

a) For practical experience in Vietnam, follow Model 02 Appendix I issued together with this Decree;

b) For practical experience at a foreign medical examination and treatment facility, the confirmation of practical experience issued by the authorized person of that facility must include the following contents: Name of the practitioner; date of birth; residential address; passport number (date of issue, place of issue); academic diploma; year of graduation; place of practice; duration of practice; assessment of the practitioner's professional competence and ethical conduct.

4. A valid copy of the labor permit issued by the competent authority of Vietnam for labor matters.

5. A valid copy of one of the following documents:

a) Certificate of proficient Vietnamese language skills for foreigners registering to use Vietnamese for diagnosis and treatment;

b) Certificate of adequate interpreting proficiency for interpreters suitable for the language registered by the practitioner for diagnosis and treatment and the employment contract between the interpreter and the medical examination and treatment facility where the practitioner works;

c) For foreigners registering to use a non-native language for diagnosis and treatment:

- Certificate of proficient use of the language registered by the practitioner for diagnosis and treatment as stipulated in Article 17 of this Decree;

- Certificate of adequate interpreting proficiency for interpreters of the language registered by the practitioner for diagnosis and treatment as stipulated in Article 18 of this Decree and the employment contract between the interpreter and the medical examination and treatment facility where the practitioner works.

6. Health certificate for practicing diagnosis and treatment issued by a medical examination and treatment facility meeting the requirements set out by the Minister of Health or a health certificate issued by a foreign medical examination and treatment facility, with the date of issuance of the health certificate not exceeding twelve months from the date of submission of the application for a professional practice certificate.

7. Criminal record (applicable in cases not requiring a labor permit).

8. Two color photographs measuring 4 cm x 6 cm taken against a white background within six months prior to the date of submission.

Article 7. Documents for Application to Adjust the Professional Practice Certificate

1. The documents for application to supplement the scope of professional activities in the professional practice certificate include:

a) An application form for supplementing the scope of professional activities in the professional practice certificate according to Model 05 of Appendix I issued together with this Decree;

b) A certified true copy of the professional practice certificate that has been issued;

c) A certified true copy of academic certificates, professional certificates, or qualification certificates corresponding to the proposed supplementary scope of professional activities;

d) A confirmation letter on practical experience in accordance with Clause 3, Article 5 of this Decree, corresponding to the academic certificates, professional certificates, or qualification certificates.

2. The documents for application to change the scope of professional activities in the professional practice certificate for medical examination and treatment include:

a) An application form for changing the scope of professional activities according to Model 06 of Appendix I issued together with this Decree;

b) A certified true copy of academic certificates, professional certificates, or qualification certificates corresponding to the proposed changed scope of professional activities;

c) The original professional practice certificate for medical examination and treatment that has been issued;

d) A confirmation letter on practical experience as prescribed in Clause 3, Article 5 of this Decree;

đ) Two color photographs measuring 04 cm x 06 cm taken against a white background within six months prior to the date of submission of the application;

3. The documents for application to change the name and date of birth in the professional practice certificate for medical examination and treatment include:

a) An application form for changing the name and date of birth according to Model 07 of Appendix I issued together with this Decree;

b) A certified true copy of documents proving the change of name and date of birth of the practitioner;

c) The original professional practice certificate for medical examination and treatment that has been issued;

d) Two color photographs measuring 04 cm x 06 cm taken against a white background within six months prior to the date of submission of the application;

Article 8. Documents for Application to Reissue the Professional Practice Certificate

1. The documents for application to reissue the professional practice certificate for those who have lost, damaged, or had their certificates revoked in accordance with points a and b of Clause 1, Article 29 of the Medical Examination and Treatment Law include:

a) An application form for reissuing the professional practice certificate according to Model 08 of Appendix I issued together with this Decree;

b) Two color photographs measuring 04 cm x 06 cm taken against a white background within six months prior to the date of submission of the application.

2. The documents for application to reissue the professional practice certificate in cases where it has been revoked in accordance with points c, d, đ, e, and g of Clause 1, Article 29 of the Medical Examination and Treatment Law include:

a) An application form for reissuing the professional practice certificate according to Model 09 of Appendix I for Vietnamese citizens or according to Model 10 of Appendix I for foreigners and overseas Vietnamese citizens issued together with this Decree;

b) A certificate of continuous medical knowledge update in accordance with the regulations of the Minister of Health;

c) The documents prescribed in Clauses 2, 4, 5, 6, and 7 of Article 5 of this Decree for Vietnamese citizens; the documents prescribed in Clauses 2, 4, 5, 6, 7, and 8 of Article 6 of this Decree for foreigners and overseas Vietnamese citizens.

Article 9. Submission of Applications for Issuance and Reissuance of Professional Practice Certificates

1. The submission of applications for issuance and reissuance of professional practice certificates as prescribed in Articles 5, 6, 7, and 8 of this Decree shall be carried out as follows:

a) Applicants for issuance and reissuance of professional practice certificates under the circumstances specified in points a, b, and c of Clause 1, Article 26 of the Medical Examination and Treatment Law shall submit one set of documents to the Ministry of Health;

b) Applicants for issuance and reissuance of professional practice certificates working at medical examination and treatment facilities under the jurisdiction of the Department of Health, except for the circumstances specified in point a of this clause, shall submit one set of documents to the Department of Health.

2. In cases where practitioners have been issued professional practice certificates by the Ministry of Health or the Department of Health but at the time of applying for issuance or reissuance of the professional practice certificate, the practitioner changes their place of work, the submission of documents shall be as follows:

a) Practitioners working at medical examination and treatment facilities under the jurisdiction of the Department of Health shall submit documents to the Department of Health where the facility is located;

b) Practitioners working at medical examination and treatment facilities under the jurisdiction of the Ministry of Health shall submit documents to the Ministry of Health.

3. In cases where practitioners are not working at any medical examination and treatment facility at the time of applying for issuance or reissuance of the professional practice certificate, they shall submit documents to the Department of Health where they are registered to reside for issuance or reissuance of the professional practice certificate.

Article 10. Procedures for Issuing, Reissuing, and Managing Professional Practice Certificates

1. After receiving the application dossier for issuing or reissuing a professional practice certificate, the Ministry of Health or the Department of Health (hereinafter referred to as the dossier-receiving authority) shall issue to the applicant a Dossier Receipt Form according to the model prescribed in Appendix II attached to this Decree, specifically as follows:

a) In cases where the dossier is submitted directly at the dossier-receiving authority, if the dossier is complete as required, the dossier-receiving authority shall immediately issue a Dossier Receipt Form to the applicant for issuing or reissuing a professional practice certificate.

b) In cases where the dossier is sent via postal service, within two days from the date of receipt of the dossier (calculated based on the postmark), the dossier-receiving authority shall send a Dossier Receipt Form to the applicant for issuing or reissuing a professional practice certificate.

2. Within twenty days from the date recorded on the Dossier Receipt Form, the dossier-receiving authority must conduct a dossier review and prepare a review record.

3. If the dossier is valid, within ten working days from the date of the review record, the dossier-receiving authority shall issue or reissue the professional practice certificate.

4. If the dossier is invalid:

a) Within five working days from the date of the review record, the dossier-receiving authority must issue a notification letter to the applicant for issuing or reissuing a professional practice certificate to complete the dossier. The notification letter must specify the necessary supplementary documents and the contents that need to be amended.

b) Upon receiving the request to complete the dossier, the applicant for issuing or reissuing a professional practice certificate must amend and supplement the dossier in accordance with the contents specified in the notification letter and submit the supplementary dossier to the dossier-receiving authority. The dossier-receiving authority shall issue a Dossier Receipt Form for the supplementary dossier to the applicant for issuing or reissuing a professional practice certificate.

c) The dossier-receiving authority shall continue to implement the procedures as stipulated in Clauses 2, 3, and Point a Clause 4 of this Article. If the supplementary dossier remains invalid, the dossier-receiving authority shall continue to guide the applicant for issuing or reissuing a professional practice certificate to complete the dossier.

d) In cases where the dossier-receiving authority has requested amendments and supplements to the dossier, but within sixty days from the date the dossier-receiving authority issued the request, the applicant for issuing or reissuing a professional practice certificate does not supplement or amend the dossier, the entire dossier and procedure for issuing or reissuing a professional practice certificate must be restarted.

5. Management of Professional Practice Certificates:

a) The professional practice certificate is issued by the Minister of Health according to Model 01 of Appendix III, and the scope of professional activities is determined by the Director of the Department of Health according to Model 02 of Appendix III and the Decision Supplementing the Scope of Professional Activities in the Professional Practice Certificate is issued by the Minister of Health and the Director of the Department of Health according to Model 03 of Appendix III attached to this Decree. The code symbol of the professional practice certificate is implemented according to Model 04 of Appendix III attached to this Decree; the scope of professional activities recorded in the professional practice certificate is carried out according to the guidance of the Minister of Health.

b) The dossier-receiving authority shall print the professional practice certificate according to the model prescribed in Point a of this clause, ensuring the continuity of the professional practice certificate number during issuance and each practitioner having only one professional practice certificate number.

c) The Department of Health shall continue to use the professional practice certificate forms provided by the Ministry of Health until December 31, 2016.

Article 11. Advisory Board for Issuing and Reissuing Professional Practice Certificates

1. The Minister of Health or the Director of the Health Department shall establish the Advisory Board for Issuing and Reissuing Professional Practice Certificates (hereinafter referred to as the Advisory Board) in accordance with Clause 4 of Article 28 of the Law on Medical Examination and Treatment.

2. The Chairman of the Advisory Board is responsible for directing the development of operational regulations of the Advisory Board to be submitted to the Minister of Health or the Director of the Health Department for approval and implementation after approval.

Section 2. REGISTRATION FOR PRACTICING MEDICAL EXAMINATION AND TREATMENT

Article 12. Principles of Registration for Practicing

1. A practitioner may only serve as the person responsible for professional technical matters at one medical examination and treatment facility.

2. A practitioner may only register to be in charge of one department at one medical examination and treatment facility. They may not simultaneously be in charge of two or more departments within the same medical examination and treatment facility or concurrently be in charge of a department at another medical examination and treatment facility.

3. A practitioner who is responsible for professional technical matters at a medical examination and treatment facility may concurrently be in charge of one department within the same medical examination and treatment facility, provided that it is consistent with the scope of professional activities specified in their issued professional practice certificate.

4. A practitioner working at a medical examination and treatment facility may register to be responsible for professional technical matters at another medical examination and treatment facility outside regular hours.

5. A practitioner working at a state-owned medical examination and treatment facility may not register to be the head of a private hospital or a medical examination and treatment facility established and operated under the Enterprise Law or the Cooperative Law, except where they are appointed by a competent state authority to manage or direct such facilities with state capital.

6. A practitioner who has registered to be responsible for professional technical matters at a medical examination and treatment facility may register to practice outside regular hours at another medical examination and treatment facility.

7. A practitioner may register to practice at one or more medical examination and treatment facilities but may not simultaneously practice at different medical examination and treatment facilities at the same time, and the total overtime work time must not exceed 200 hours as stipulated by the Labor Code. The practitioner must ensure reasonable travel time between registered practice locations.

8. A practitioner who has registered to practice at a medical examination and treatment facility when performing medical examination and treatment services under a rotation system, humanitarian medical examination and treatment, or specialized technical procedures pursuant to contracts between medical examination and treatment facilities does not need to register to practice at those medical examination and treatment facilities.

Article 13. Registration for Practicing Medical Examination and Treatment

1. The registration for practicing is made by the person responsible for professional technical matters at the medical examination and treatment facility according to the Model prescribed in Appendix IV attached to this Decree.

2. Content of registration for practicing:

a) Place of practice: Clearly state the name and address of the medical examination and treatment facility where the practice is registered;

b) Time of practice: Specifically record the time of practice: Hours in a day, days in a week practicing at the medical examination and treatment facility and ensuring reasonable travel time between registered practice locations as stipulated in point a of this clause;

c) Position and professional role of the practitioner: The list of practitioners registering to practice must clearly state the position assigned to the practitioner as the person responsible for professional technical matters or the head of a department or other professional roles of the practitioner.

3. In cases where the list of practitioners registering to practice at a medical examination and treatment facility includes practitioners already practicing at another medical examination and treatment facility, the registration for practicing of such practitioners must clearly state the time, place, and professional role of the practitioner at the other medical examination and treatment facility.

Article 14. Procedure for Registration of Practice

1. Time of registration for practice:

a) For healthcare facilities applying for a business operation permit, the registration of practitioners shall be conducted simultaneously with the application for the business operation permit;

b) For healthcare facilities that have already been granted a business operation permit, if there is a change in personnel, within 10 working days from the date of such change, the person responsible for technical and professional matters at the healthcare facility must notify the competent authority receiving the practice registration documents as stipulated in Clause 2, Article 14 of this Decree.

2. Receiving practice registration documents in cases of changes in practitioners:

a) The Ministry of Health receives the registration of practice for healthcare facilities under the Ministry of Health;

b) The Department of Health receives the registration of practice for healthcare facilities located within their administrative area, except for those healthcare facilities specified in point a of this clause.

Article 15. Management of Information on Practice Registration

1. Within five working days from the date of issuance of the business operation permit or receipt of the list of changes in practitioners as stipulated in Clause 1, Article 14 of this Decree, the Department of Health, according to its authority to receive the registration of practitioners as stipulated in point b, Clause 2, Article 14 of this Decree, must send the list of practitioners to the Ministry of Health.

2. Within five working days from the date of issuance of the business operation permit or receipt of the list of changes in practitioners as stipulated in Clause 1, Article 14 of this Decree, the Ministry of Health, according to its authority to receive the registration of practitioners as stipulated in point a, Clause 2, Article 14 of this Decree, sends the list of practitioners to the Department of Health where the healthcare facility with registered practitioners is located.

3. The publication of the list of registered practitioners shall be carried out as follows:

a) The Ministry of Health publishes the national list of registered practitioners with all information as prescribed in Appendix IV issued together with this Decree on the Ministry of Health's electronic portal;

b) The Department of Health publishes the list of registered practitioners with all information as prescribed in Appendix IV issued together with this Decree on the Department of Health's electronic portal according to its authority to receive the registration of practitioners as stipulated in point b, Clause 2, Article 14 of this Decree.

Section 3. PRACTICAL TRAINING FOR ISSUANCE OF PRACTICE CERTIFICATE

Article 16. Organization of Practical Training

1. Acceptance of trainees:

a) Trainees must submit a practical training request form according to Model 01 in Appendix V issued together with this Decree and a valid copy of relevant professional qualification certificates related to healthcare to the healthcare facility where they intend to undergo practical training;

b) After receiving the practical training request form, if agreeing to accept, the head of the healthcare facility is responsible for signing a practical training contract with the trainee according to Model 02 in Appendix V issued together with this Decree.

2. Assignment of practical training instructors:

The head of the healthcare facility issues a decision assigning practical training instructors according to Model 03 in Appendix V issued together with this Decree. One instructor can guide a maximum of five trainees at the same time.

3. Practical training instructors must meet the following conditions:

a) Hold a practice certificate;

b) Have a scope of professional activities consistent with the qualifications of the trainee, having equivalent or higher educational qualifications than the trainee and having continuously practiced healthcare for at least three years.

4. Responsibilities of practical training instructors:

a) Guide practical training in healthcare for trainees;

b) Evaluate the results of practical training and bear responsibility for the content of their evaluations;

c) Bear responsibility in cases where trainees cause professional errors during practical training, affecting patient health due to the instructor's fault.

5. Issuance of a Certificate Confirming Practical Training: After receiving a written evaluation from the practical training instructor regarding the trainee, the head of the healthcare facility issues a Certificate Confirming Practical Training according to Model 02 in Appendix I issued together with this Decree.

Section 4. CRITERIA FOR RECOGNITION OF FLUENCY IN VIETNAMESE OR FLUENCY IN ANOTHER LANGUAGE OR SUITABLE INTERPRETING LEVEL IN HEALTHCARE

Article 17. Criteria for Recognizing Individuals Practicing Medicine as Proficient in Vietnamese or Another Language

1. An individual practicing medicine shall be recognized as proficient in Vietnamese in medical diagnosis and treatment when they are tested and certified by the educational institution specified in Article 19 of this Decree, except for cases stipulated in Clause 3 of this Article.

2. In cases where an individual practicing medicine registers to use a language other than their native language or Vietnamese for medical diagnosis and treatment, they must be tested and certified by the educational institution specified in Article 19 of this Decree as proficient in the language registered for use in medical diagnosis and treatment, except for cases stipulated in Clause 3 of this Article.

3. Individuals may be recognized as proficient in Vietnamese or another language in medical diagnosis and treatment without undergoing testing if they meet any of the following criteria:

a) Hold a diploma in a specialized medical field at the intermediate level or higher issued by a legitimate training institution in Vietnam or abroad, with Vietnamese or the language registered for use in medical diagnosis and treatment being the language used during the training period;

b) Hold a certificate of completion of specialized medical training courses with a minimum duration of twelve months, with Vietnamese or the language registered for use in medical diagnosis and treatment being the language used during the training period;

c) Hold a diploma in Vietnamese or the language registered for use in medical diagnosis and treatment at the bachelor's level or higher issued by a legitimate training institution in Vietnam or abroad.

The diplomas and certificates specified in Points a and b of this Clause must have been issued within a period not exceeding five years from the date of submission of the application.

Article 18. Criteria for Recognizing Individuals as Qualified Interpreters in Medical Diagnosis and Treatment

1. An individual shall be recognized as qualified to interpret languages in medical diagnosis and treatment when they are tested and certified by the educational institution specified in Article 19 of this Decree, except for cases stipulated in Clause 2 of this Article.

2. Individuals may be recognized without undergoing testing if they meet any of the following criteria:

a) Hold a diploma in a specialized medical field at the intermediate level or higher issued by a legitimate training institution in Vietnam or abroad, with the language used during the training period being the language the interpreter registers to interpret;

b) Hold a certificate of completion of specialized medical training courses with a minimum duration of twelve months, with the language used during the training period being the language the interpreter registers to interpret;

c) Hold a diploma in a specialized medical field at the intermediate level or higher or a traditional doctor’s degree and a bachelor's degree in foreign languages corresponding to the language the interpreter registers to interpret.

The diplomas and certificates specified in Points a and b of Clause 2 of this Article must have been issued within a period not exceeding five years from the date of submission of the application.

3. An interpreter can only interpret for one individual practicing medicine at the same time while that individual is diagnosing and treating a patient.

Article 19. Conditions for educational institutions to be inspected and recognized as having proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment

Educational institutions shall be inspected and recognized as having proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment if they meet the following conditions:

1. It is a specialized university in medicine in Vietnam.

2. Has a department or subject of foreign languages of one of the following languages: English, French, Russian, Chinese, Japanese, and Korean.

3. Has a bank of tests to inspect and recognize proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment.

Article 20. Documents and procedures for issuing certificates recognizing educational institutions as meeting the conditions to inspect and recognize proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment

1. Documents:

a) A certified copy of documents proving the establishment and operation of the educational institution;

b) Documents proving the existence of a department or subject of foreign languages as stipulated in Clause 2 of Article 19 of this Decree and a list of full-time lecturers working in the department or subject of foreign languages;

c) A bank of tests used to inspect and recognize proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment of at least one of the following languages: English, French, Russian, Chinese, Japanese, and Korean.

2. In cases where an educational institution has already been issued a Certificate recognizing it as meeting the conditions to inspect and recognize proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment and requests to add additional languages for inspection and recognition, the application documents shall comply with the provisions of points b and c of this clause.

3. Procedures:

a) The educational institution submits one set of application documents for the issuance of a certificate recognizing it as meeting the conditions to inspect and recognize proficient Vietnamese language skills or proficiency in another language or sufficient interpreting level in medical examination and treatment (hereinafter referred to as language inspection) according to the provisions of Clause 1 of this Article to the Ministry of Health;

b) Upon receipt of the application documents, the Ministry of Health sends the educational institution a Receipt of Application Documents according to Form 01 of Appendix VI promulgated together with this Decree;

c) Within 15 days from the date of receiving the application documents, if the documents are valid, the Ministry of Health must issue a Certificate recognizing the educational institution as meeting the conditions for language inspection in medical examination and treatment according to Form 02 of Appendix VI promulgated together with this Decree. If rejected, a written notice stating the reasons must be provided;

d) In cases where the application documents are not valid, within 5 working days from the date recorded on the Receipt of Application Documents, the agency receiving the application documents must provide a written notification to the educational institution specifying the contents that need to be amended and supplemented to complete the application documents.

đ) Within 15 days from the date of receiving the amended and supplemented application documents, the agency receiving the application documents must issue a Certificate recognizing the educational institution as meeting the conditions for language inspection according to Form 02 of Appendix VI promulgated together with this Decree; if the Certificate is not issued, a written response stating the reasons must be provided.

e) Within 10 days from the date of issuing the Certificate recognizing the educational institution as meeting the conditions for language inspection, the Ministry of Health publicly posts the name of the institution that has been issued the Certificate on its official website.

Article 21. Documents and procedures for requesting inspection and recognition of proficiency in Vietnamese or other languages or sufficient interpreting level in medical examination and treatment

1. The documents for requesting inspection and recognition of language proficiency in medical examination and treatment include:

a) Application form according to Model 01 Appendix VII issued together with this Decree;

b) A valid copy of identity card or passport still within its validity period;

c) Two color photographs measuring 04 cm x 06 cm taken against a white background within six months prior to the date of submission of the application.

2. The documents for requesting recognition of proficiency in Vietnamese or other languages or sufficient interpreting level in medical examination and treatment include:

a) Application form for recognition of proficiency in Vietnamese or other languages or sufficient interpreting level in medical examination and treatment according to Model 02 Appendix VII issued together with this Decree;

b) The documents specified in points b and c of Clause 1 of this Article;

c) A valid copy of the diploma or certificate prescribed in Clause 3 of Article 17 of this Decree for cases requesting recognition of proficiency in Vietnamese or other languages for medical examination and treatment; the diploma or certificate prescribed in Clause 2 of Article 18 of this Decree for persons requesting recognition of sufficient interpreting level in medical examination and treatment.

3. Inspection and recognition procedures:

a) The person requesting recognition shall submit one set of documents as stipulated in Clause 1 of this Article to the educational institution as prescribed in Article 19 of this Decree;

b) Within thirty days from the date of receipt of complete and valid documents, the educational institution must inspect and issue a certificate according to Model 03 Appendix VII issued together with this Decree for the cases prescribed in Clauses 1 and 2 of Article 17 and Clause 1 of Article 18. The inspection results must be publicly announced.

4. Recognition procedures:

a) The person requesting recognition shall submit one set of documents as stipulated in Clause 2 of this Article to the educational institution as prescribed in Article 19 of this Decree;

b) Within ten working days from the date of receipt of complete and valid documents, the educational institution must issue a certificate for the cases prescribed in Clause 3 of Article 17 and Clause 2 of Article 18 of this Decree. In case of non-issuance of the certificate, there must be a written response stating the reasons.

Chapter III

CONDITIONS, DOCUMENTS AND PROCEDURES FOR ISSUING, RENEWING AND AMENDING LICENSES FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Section 1. CONDITIONS FOR ISSUING LICENSES FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 22. Organizational forms of medical examination and treatment facilities

Medical examination and treatment facilities are established in accordance with the law and must follow one of the following organizational forms:

1. Hospitals including general hospitals and specialized hospitals.

2. Health stations under the People's Public Security force.

3. General outpatient clinics.

4. Specialized outpatient clinics, including:

a) Internal medicine outpatient clinic;

b) Specialized internal medicine outpatient clinics: Cardiology, respiratory, digestive, pediatrics and other internal medicine specialties;

c) Health consultation outpatient clinic or health consultation outpatient clinic through information and communication technology means;

d) Surgical outpatient clinic;

đ) Obstetrics and Gynecology outpatient clinic;

e) Andrology outpatient clinic;

g) Dental outpatient clinic;

h) Otorhinolaryngology outpatient clinic;

i) Ophthalmology outpatient clinic;

k) Aesthetic surgery outpatient clinic;

l) Rehabilitation outpatient clinic;

m) Psychiatry outpatient clinic;

n) Oncology outpatient clinic;

o) Dermatology outpatient clinic;

p) Nutritional outpatient clinic;

q) Outpatient clinic supporting drug rehabilitation treatment;

r) HIV/AIDS outpatient clinic and treatment center;

s) Outpatient clinic and treatment center for drug addiction treatment using substitute drugs in accordance with the provisions of Government Decree No. 90/2016/NĐ-CP dated July 1, 2016 on drug substitution treatment for drug addiction;

t) Other specialized outpatient clinics.

5. Traditional Chinese Medicine Outpatient Clinic.

6. Family Medicine Examination and Treatment Facility (or Examination and Treatment Facility based on Family Medicine Principles): To be piloted in accordance with the regulations of the Minister of Health.

7. Laboratory.

8. Diagnostic Imaging Clinic, X-ray Room.

9. Medical Forensic Examination Facility, Legal Medical Examination Facility, Forensic Psychiatry Facility that conducts medical examination and treatment must be organized in accordance with the organizational form of medical examination and treatment facility prescribed in Clause 3 of this Article. Forensic Psychiatry Facility that conducts medical examination and treatment must be organized in accordance with one of the organizational forms of medical examination and treatment facility prescribed in Clauses 1, 3 or point m of Clause 4 of this Article. These facilities must meet the corresponding conditions for each organizational form of medical examination and treatment facility.

10. Maternity Home.

11. Outpatient Clinic, Counseling and Preventive Treatment Center.

12. Occupational Disease Outpatient Clinic and Treatment Center.

13. Healthcare Service Facility including:

a) Vaccination, Bandaging, Pulse Counting, Temperature Measurement, Blood Pressure Measurement Service Facility;

b) Home Health Care Service Facility;

c) Emergency and Patient Transport Support Service Facility within and outside the country;

d) Prescription Dispensing Service Facility;

đ) Aesthetic Service Facility;

e) Massage Service Facility;

g) Other Healthcare Service Facilities.

14. Commune Health Station, Health Post.

15. Healthcare Facility of agencies, units, organizations conducting medical examination and treatment must comply with one of the organizational forms prescribed in Clause 3, point a of Clause 4 or Clause 14 of this Article and must meet the corresponding conditions for such organizational forms.

16. Central Health Facility with medical examination and treatment functions shall be granted a license to operate in the equivalent organizational form of a general hospital or general outpatient clinic.

17. In the case where a medical examination and treatment facility conducts HIV testing, in addition to complying with the provisions of this Decree, it must also comply with the provisions of Government Decree No. 75/2016/NĐ-CP dated July 1, 2016 on Conditions for Conducting HIV Testing.

18. In the case where a medical examination and treatment facility conducts vaccination, in addition to complying with the provisions of this Decree, it must also comply with the provisions of Government Decree No. 104/2016/NĐ-CP dated July 1, 2016 on Vaccination Activities.

19. In the case where a medical examination and treatment facility has a microbiology laboratory, samples that may contain pathogenic microorganisms capable of causing infectious diseases in humans must comply with the provisions of this Decree and also meet the requirements set forth in Decree No. 103/2016/NĐ-CP dated July 1, 2016 of the Government on ensuring biosafety in laboratories.

Article 23. Conditions for Issuing a Permit to Operate a Hospital

1. Scale of the hospital:

a) A general hospital must have at least 30 beds;

b) A specialized hospital or a traditional medicine hospital must have at least 20 beds; specifically, a specialized eye hospital using advanced technology must have at least 10 beds.

2. Infrastructure:

a) Depending on the scale of the general or specialized hospital, the hospital must be designed and constructed in a multi-block form and must meet the following conditions:

- Arranging departments, rooms, corridors to ensure professional activities according to a centralized, continuous, and enclosed model within the hospital premises; ensuring sterile conditions and environmental hygiene as prescribed by law;

- For general hospitals and specialized hospitals, the construction area must be at least 50 square meters per bed; the width of the front facade (front face) of the hospital must be at least 10 meters.²b) Ensuring conditions for radiation safety, medical waste management, and fire prevention and extinguishing as prescribed by law.

c) Ensuring sufficient electricity, water, and other conditions to serve patient care.

3. Medical Equipment:

a) Having adequate medical equipment and instruments suitable for the hospital's professional scope;

b) Having sufficient emergency transport facilities both inside and outside the hospital. If there are no emergency transport facilities outside the hospital, a service contract must be made with a medical examination and treatment facility that has been issued a permit and has the professional scope to provide emergency transport services.

4. Organization:

a) Departments:

- At least two out of four internal medicine, surgery, obstetrics, pediatrics departments for general hospitals or one clinical department appropriate for specialized hospitals;

- Outpatient Department: Having a reception area, emergency room, ward, consultation room, minor surgery room (if performing minor surgeries);

- Ancillary Clinical Department: Having at least one laboratory and one diagnostic imaging room. Specifically, for specialized eye hospitals without a diagnostic imaging unit, a professional support contract must be made with a medical examination and treatment facility that has been issued a permit and has a diagnostic imaging unit;

- Pharmacy Department;

- Other specialized departments in the hospital must be appropriate to the scale and functions.

b) Having rooms and units to perform functions related to planning, human resources organization, quality management, nursing, finance and accounting, and other necessary functions.

5. Personnel:

a) The number of full-time practitioners (permanent staff) in each department must reach at least 50% of the total number of practitioners in the department;

b) The number of staff, structure, and occupational title standards shall be implemented in accordance with the regulations of the Minister of Health;

c) The person responsible for technical expertise in the hospital must meet the following conditions:

- Being a physician with a practice certificate with a professional scope consistent with at least one of the specialties registered for operation by the hospital;

- Having at least 54 months of experience in medical examination and treatment in those specialties. The assignment and appointment of the person responsible for technical expertise in the hospital must be documented in writing;

- Being a permanent practitioner at the hospital.

d) The head of the clinical department must meet the following conditions:

- Being a physician with a practice certificate consistent with the specialty;

- Having at least 54 months of experience in medical examination and treatment in that specialty. The assignment and appointment of the head of the department must be documented in writing;

đ) Heads of ancillary clinical departments (laboratory, microbiology, pathology):

d) The head of the clinical department must meet the following conditions:

- Head of the Laboratory Department: Being a physician or laboratory technician specializing in laboratory science, a bachelor's degree in chemistry, biology, or pharmacy, holding a practice certificate in laboratory science.

Laboratory technicians with a bachelor's degree can read and sign test results. In cases where a medical examination and treatment facility does not have a physician specializing in laboratory science, the physician who orders the tests will make the diagnosis.

- If there is a separate microbiology department, the head of the microbiology department: Being a physician or laboratory technician specializing in laboratory science with a bachelor's degree or higher, holding a practice certificate in microbiology or a bachelor's degree in chemistry, biology, or pharmacy for those recruited as laboratory specialists before the effective date of this Decree, who are granted a practice certificate in microbiology.

- If there is a separate pathology department, the head of the pathology department: Being a physician specializing in pathology or a physician with training in pathology and holding a practice certificate in pathology.

- Having at least 54 months of work experience in laboratory science, microbiology, or pathology, or having at least 36 months of professional experience in laboratory science, microbiology, or pathology, including postgraduate study time in these specialties, calculated from the start of laboratory, microbiology, or pathology work (determined from the date of signing the labor contract or employment decision) to the date of assignment and appointment as the person responsible for technical expertise in the laboratory, microbiology, or pathology department.

e) Head of Diagnostic Imaging Department, Head of Radiology Department:

d) The head of the clinical department must meet the following conditions:

- The head of the Diagnostic Imaging Department must be a physician with a practice certificate in diagnostic imaging and have at least 54 months of direct experience in medical examination and treatment in diagnostic imaging, or have at least 36 months of professional experience in diagnostic imaging, including postgraduate study time in these specialties, calculated from the start of diagnostic imaging work (determined from the date of signing the labor contract or employment decision) to the date of assignment and appointment as the person responsible for technical expertise in the department.

- The Head of the Diagnostic Imaging Department must be a physician holding a professional practice certificate in diagnostic imaging and having at least 54 months of direct experience in diagnosing and treating diseases related to diagnostic imaging, or having at least 36 months of specialized practice in diagnostic imaging, including postgraduate study time in these specialties, calculated from the date of commencement of diagnostic imaging work (determined from the date of signing the labor contract or the recruitment decision) until the date of assignment or appointment as the person responsible for technical expertise of the department;

- The Head of the Radiology Department must be a Bachelor of Radiology with a university degree or higher, holding a practice certificate, and having at least 54 months of direct experience in diagnosing and treating radiology cases or at least 36 months of specialized radiology practice, including postgraduate study time in this specialty, calculated from the date of starting radiology work (determined from the signing of the labor contract or employment decision) to the date of being assigned and appointed as the person responsible for the technical and professional management of the department. A Bachelor of Radiology with a university degree can read and describe diagnostic images but cannot make diagnostic conclusions.

- In cases where the medical examination and treatment facility does not have a specialist doctor in imaging diagnosis or a radiologist, the imaging diagnosis technique prescribing doctor shall make diagnostic conclusions.

d) The head of the clinical department must meet the following conditions:

g) The Head of the Pharmacy Department must be a practicing pharmacist at the hospital and must comply with the provisions of the pharmaceutical laws.

h) The Heads of other departments that are not required to hold a practice certificate must meet the following conditions:

- Graduated from university and having at least 36 months of work experience in that specialty from the date of receiving the university graduation diploma to the date of being assigned and appointed as the department head. The assignment and appointment of the department head must be documented in writing.

d) The head of the clinical department must meet the following conditions:

i) In addition to the subjects specified in points c, d, đ, e, g, and h of this clause, other subjects working in the hospital who perform medical examinations and treatments must hold a practice certificate and can only perform medical examinations and treatments within the scope of work assigned to them. The assignment must be documented in writing and consistent with the scope of professional activities recorded on the practice certificate.

k) There must be a radiation safety officer (if the facility uses radioactive source equipment, radiotherapy drugs, and nuclear medicine equipment).

6. Hospitals conducting health check-ups and issuing Health Certificates, in addition to meeting the conditions stipulated in this Article, must also meet the following conditions:

a) Personnel Conditions:

- The person concluding the health examination results: Must be a doctor with a practice certificate for medical examination and treatment, having at least 54 (fifty-four) months of medical examination and treatment experience, and assigned by the authorized person of the medical examination and treatment facility to conclude health status, sign the health examination certificate, and the regular health examination book. The assignment must be documented in writing.

- Medical examination and treatment facilities conducting health check-ups for foreigners, overseas Vietnamese residents, and Vietnamese workers abroad under contracts and students studying abroad (hereinafter referred to as foreign-related health examination facilities), in addition to meeting the above conditions, must also meet the following additional conditions:

+ The clinical examiners and the persons concluding the health examination results must be primary care specialists, master's degree holders in medicine, or intern doctors or higher.

+ When the person undergoing the health examination and the examiner do not speak the same language fluently, there must be an interpreter. The interpreter must have a certificate proving their proficiency in interpreting during medical examinations and treatments according to Article 18 of this Decree.

b) Professional Conditions:

- For health examination facilities without foreign elements: Must have all clinical departments including Internal Medicine, Pediatrics, Surgery, Obstetrics and Gynecology, Ophthalmology, Otorhinolaryngology, Dentistry, Dermatology, and ancillary departments including X-ray room and laboratory.

- For health examination facilities with foreign elements, in addition to meeting the above conditions, they must also be able to perform the following ancillary techniques:

+ Blood tests: Blood formula, ABO blood group, Rh blood group, erythrocyte sedimentation rate, hemoglobin ratio, urea in blood;

+ Finding malaria parasites in blood;

+ Testing for Hepatitis A, B, C, and E;

+ Syphilis serological test;

+ HIV (HIV positive) confirmation test;

+ Tuberculin skin test;

+ Pregnancy test;

+ Drug testing;

+ Stool test for parasites;

+ Electrocardiogram;

+ Electroencephalogram;

+ Ultrasound;

+ Leprosy diagnosis test.

In cases where the facility does not have the conditions to perform HIV (HIV positive) confirmation tests, leprosy diagnosis tests, and electroencephalograms, it must enter into a professional support contract with a medical examination and treatment facility that has a license to operate and is permitted to perform these techniques.

- For health examination facilities for drivers: In addition to meeting the conditions for health examination facilities without foreign elements, they must also be able to perform the following techniques:

+ Electroencephalogram (EEG);

+ Visual acuity test;

+ Blood alcohol concentration test, breath alcohol concentration test;

+ Confirmation test for drug, drug, and psychoactive substance use.

In cases where the health examination facility for drivers does not have the conditions to perform EEG and visual acuity tests, it must enter into a professional support contract with a medical examination and treatment facility that has a license to operate and is permitted to perform these techniques.

c) Equipment Conditions: Must have sufficient medical equipment and tools suitable for professional activities and the content of health examinations.

d) Medical examination and treatment facilities conducting health examinations must complete the documentation and procedures for announcing the facility's eligibility to conduct health examinations according to Clause 8 of Article 43 and Clauses 4 and 5 of Article 44 of this Decree after obtaining the operating permit.

Article 24. Conditions for Issuing a Permit to Operate a Clinic Belonging to the People's Public Security Force

1. Scale

The clinic must have at least 10 beds or more.

2. Material Basis

a) There must be a reception area for patients, consultation rooms, emergency rooms, patient rooms, and laboratory rooms with sufficient space to deploy medical equipment and tools for medical examination and treatment activities.

b) Ensure radiation safety conditions, medical waste management, fire prevention and firefighting according to the provisions of the law.

c) Ensure adequate electricity, water, and other conditions necessary to serve patient care.

3. Medical Equipment

Must have sufficient medical equipment and tools appropriate to the scope of specialized activities registered by the clinic.

4. Organization: Must have at least two internal and external departments, including an emergency room; patient room; clinical auxiliary department.

a) The number of full-time practitioners (permanent staff) in each department must reach at least 50% of the total number of practitioners in the department;

a) The person responsible for technical expertise at the clinic must be a doctor with a practice certificate suitable for one of the specialized fields registered by the clinic and must have at least 54 months of experience in medical examination and treatment in that field.

b) In addition to the person responsible for technical expertise at the clinic, other individuals working at the clinic who perform medical examinations and treatments must have a practice certificate and can only carry out such activities within the scope of work assigned to them. The assignment must be consistent with the scope of specialized activities recorded on their practice certificate.

Article 25. Conditions for Issuing a Permit to Operate a General Outpatient Clinic

1. Scale of a general outpatient clinic:

a) A general outpatient clinic must meet at least the following conditions:

- Have at least two out of four internal, external, obstetric, and pediatric departments;

- Have an emergency room, minor surgery room (if performing minor surgeries), and patient retention room;

- Have a laboratory and diagnostic imaging department.

b) If a general outpatient clinic meets the conditions of healthcare service facilities specified in Articles 33, 34, 35, 36, 37, and 38 of this Decree, the general outpatient clinic may expand its scale and scope of specialized activities accordingly.

2. Infrastructure:

a) Fixed location, separate from family living areas, ensuring sufficient lighting, with dust-proof ceilings, walls and floors using materials that are easy to clean and sanitize.

b) There must be a reception area, emergency room, patient retention room, specialized consultation rooms, and minor surgery room (if performing minor surgeries). Each room in the general outpatient clinic must meet the minimum requirements regarding area as follows:

- Emergency room must have an area of at least 12 square meters²;

- Patient retention room must have an area of at least 15 square meters²; must have at least two retention beds, if there are three or more retention beds, the area must ensure at least 5 square meters² per bed;

- Specialized consultation rooms and minor surgery rooms must have an area of at least 10 square meters².

c) Ensure radiation safety conditions, medical waste management, fire prevention and firefighting according to the provisions of the law.

d) Ensure adequate electricity, water, and other conditions necessary to serve patient care.

a) Having adequate medical equipment and instruments suitable for the hospital's professional scope;

a) Must have sufficient medical equipment and tools appropriate to the scope of specialized activities registered by the general outpatient clinic;

b) Must have a shock box and sufficient specialized emergency medications.

4. Personnel:

a) The number of doctors practicing medical examination and treatment must account for at least 50% of the total number of doctors practicing medical examination and treatment at the general outpatient clinic.

b) The person responsible for technical expertise at the general outpatient clinic must meet the following conditions:

- Be a doctor with a practice certificate suitable for at least one of the specialized fields registered by the general outpatient clinic;

- Have at least 54 months of experience in medical examination and treatment. The assignment and appointment of the person responsible for technical expertise at the general outpatient clinic must be documented in writing;

- Be a permanent employee at the general outpatient clinic.

c) The number of employees, structure, and occupational titles of the general outpatient clinic shall be implemented according to the regulations of the Minister of Health.

In addition to the person responsible for technical expertise at the general outpatient clinic, other individuals working at the general outpatient clinic who perform medical examinations and treatments must have a practice certificate, and the assignment must be consistent with the scope of specialized activities recorded on their practice certificate.

5. For general outpatient clinics that conduct health check-ups, they must meet the conditions stipulated in Clause 6 of Article 23 of this Decree.

6. For family medicine facilities conducting medical examinations and treatments, they shall follow the pilot regulations of the Minister of Health.

Article 26. Conditions for Issuing a License to Operate a Specialty Outpatient Clinic

1. Infrastructure:

a) Meeting the conditions stipulated in point a, Clause 2, Article 25 of this Decree.

b) A specialty outpatient clinic must have a medical examination and treatment room with an area of at least 10 square meters and a reception area for patients (except for health consultation clinics or health consultation through information technology and telecommunications means). For surgical specialty outpatient clinics and aesthetic medicine specialty outpatient clinics, there must be an additional patient retention room with an area of at least 12 square meters. Rehabilitation specialty outpatient clinics must have an additional rehabilitation room with an area of at least 10 square meters. HIV/AIDS outpatient clinics and treatment facilities must have an area of at least 18 square meters (excluding waiting areas), divided into two rooms for conducting medical examinations and providing counseling services to patients.² c) In addition to the provisions in points a and b of this clause, depending on the scope of professional activities registered, a specialty outpatient clinic must also meet the following conditions:²- In cases where procedures are performed, including dental implant techniques, the procedure room must have an area of at least 10 square meters.²- In cases where functional examinations are conducted, the functional examination room must have an area of at least 10 square meters.² - In cases where gynecological examinations or sexually transmitted disease examinations are conducted, the examination room must have an area of at least 10 square meters.

- In cases where family planning techniques are performed, the family planning technique room must have an area of at least 10 square meters.

- In cases where plastering is performed, the plastering room must have an area of at least 10 square meters.²;

- In cases where therapeutic exercise is performed, the therapeutic exercise room must have an area of at least 20 square meters.²;

- In cases where a dental-maxillofacial specialty outpatient clinic has more than one dental chair, it must ensure an area of at least 5 square meters for each dental chair.²;

- In cases where radiation equipment (including dental X-ray machines attached to dental chairs) is used, the requirements of the law on radiation safety must be met.²;

- In cases where HIV/AIDS outpatient clinics and treatment facilities provide antiretroviral drugs (ARVs), they must have a drug storage and distribution area that meets the conditions specified by the Minister of Health.²;

d) A separate sterilization area must be arranged to process reusable medical instruments.²;

đ) Ensuring conditions for radiation safety, medical waste management, fire prevention and firefighting according to the law; ensuring sterility for procedure rooms.²;

e) Having sufficient electricity, water, and other conditions to serve and care for patients.

2. Medical Equipment:

a) Having adequate medical equipment and supplies suitable for the scope of professional activities registered by the facility.

b) Having a shock box and sufficient specialized emergency medications.

c) Health consultation clinics or health consultations through information technology and telecommunications means do not need to have the medical equipment and supplies specified in points a and b of this clause but must have sufficient information technology and telecommunications equipment and supplies appropriate to their registered scope of activities.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

- Being a physician with a practice certificate corresponding to the specialty registered by the clinic.

- Having at least 54 months of experience in examining and treating patients in that specialty.

Additionally, for the following specialty outpatient clinics, the person responsible for technical expertise must meet the following conditions:

3. Personnel:

+ Rehabilitation specialty outpatient clinics: Being a physician with a practice certificate in physical therapy or rehabilitation.

+ Outpatient clinics and treatment facilities for drug addiction support: Being a psychiatrist, a general practitioner with a training certificate in psychiatry, or a traditional medicine specialist with a training certificate in drug addiction support using traditional medicine methods.

+ HIV/AIDS outpatient clinics and treatment facilities: Being an infectious diseases specialist or a general practitioner with a certificate of training and instruction in HIV/AIDS treatment.

+ Nutrition specialty outpatient clinics: Being a nutrition specialist or a general practitioner with a training certificate in nutrition.

+ Aesthetic medicine specialty outpatient clinics: Being a plastic surgery specialist or a plastic surgery and aesthetic medicine specialist.

+ Male reproductive health specialty outpatient clinics: Being a male reproductive health specialist or a general practitioner with a training certificate in male reproductive health.

b) In addition to the person responsible for technical expertise of the specialty outpatient clinic, other individuals working in the specialty outpatient clinic who perform medical examinations and treatments must have a practice certificate and be assigned tasks consistent with the scope of professional activities recorded in their practice certificate.

+ Nutritional Clinic: A physician specializing in nutrition or a general physician with a training certificate in nutritional specialization;

+ Aesthetic Specialty Clinic: A physician specializing in plastic surgery or aesthetic plastic surgery;

+ Andrology Specialty Clinic: A physician specializing in andrology or a general physician with a training certificate in andrology specialization;

b) In addition to the person responsible for technical expertise of the specialty clinic, other individuals working in the specialty clinic who perform diagnosis and treatment activities must have a professional practice certificate and be assigned tasks consistent with the scope of professional activities recorded on their professional practice certificate.

Article 27. Conditions for Issuing a Permit to Operate Traditional Medicine Clinics

1. Infrastructure:

a) Meeting the conditions stipulated in point a, Clause 2, Article 25 of this Decree.

b) The clinic must have an area of at least 10 square meters² and a reception area for patients.

c) Depending on the scope of professional activities registered, traditional medicine clinics must also meet the following conditions:

- In cases where acupuncture, massage, and acupressure are performed, there must be a room or a designated area for acupuncture, massage, and acupressure with an area of at least 05 square meters² per bed;

- In cases where herbal steam therapy is performed, there must be a steam room with an area of at least 02 square meters² and it must be enclosed but well-lit.

d) Ensure radiation safety conditions (if using radiation equipment), medical waste management, and fire prevention and control in accordance with the law.

đ) Ensure sufficient electricity, water, and other conditions necessary to serve patient care.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

a) If conducting medical examinations, prescribing, and dispensing medication:

- There must be a medicine cabinet, with herbs stored in drawers or in transparent glass or white plastic containers with lids and clearly labeled with the name of the herb on the outside;

- There must be a scale for measuring herbs and a method for dividing herbs according to prescriptions, using paper for wrapping herbs (not newspaper or paper with writing).

b) In cases where acupuncture, massage, and acupressure are performed, the following equipment must be available:

- There must be an acupuncture, massage, and acupressure bed;

- There must be sufficient tools for acupuncture, massage, and acupressure;

- There must be sufficient tools and instructions for handling acupuncture needles.

c) In cases where herbal steam therapy is performed: There must be a system for generating herbal steam, a valve for adjusting steam flow, a guide for steam therapy, and an alarm system for emergencies.

3. Personnel:

a) Personnel working at the facility who conduct medical examinations and treatments must have a practice certificate and be assigned tasks that match their professional scope of work as stated in their practice certificate.

b) The person responsible for technical and professional management of the traditional medicine clinic must be a specialist doctor or specialist technician in traditional medicine, or someone holding a certificate from the Minister of Health or the Director of the Department of Health certifying them as a traditional medicine practitioner, or someone with a family prescription or family treatment method, and must hold a practice certificate for traditional medicine medical examination and treatment.

- For specialist doctors in traditional medicine, they must have at least 54 months of experience in traditional medicine medical examination and treatment;

- For specialist technicians in traditional medicine, they must have at least 48 months of experience in traditional medicine medical examination and treatment;

- For traditional medicine practitioners or those with family prescriptions or family treatment methods, they must have at least 36 months of experience in traditional medicine medical examination and treatment;

- They must be permanent practitioners at the traditional medicine clinic.

Article 28. Conditions for Issuing a Permit to Operate a Laboratory

1. Infrastructure:

a) Meet the conditions stipulated in points a, đ, and e of Clause 1, Article 26 of this Decree, and the following conditions depending on the scope of professional activities registered:

- In cases where one of the hematological, biochemical, genetic, or immunological tests is conducted, the laboratory must have an area of at least 10 square meters²;

- In cases where two or three of the hematological, biochemical, genetic, or immunological tests are conducted, the laboratory must have an area of at least 15 square meters²;

- In cases where all four hematological, biochemical, and genetic tests are conducted, the laboratory must have an area of at least 20 square meters²;

- In cases where pathology and cytology tests are conducted, the laboratory must have a minimum area of 20 square meters² and must be separate from the hematological, biochemical, genetic laboratories and other laboratories;

- In cases where microbiological tests are conducted, the laboratory must have an area of at least 20 square meters² and must be separate from the hematological, biochemical, genetic laboratories and other laboratories;

- The walls of the laboratory must be made of waterproof material up to the ceiling;

- The floor of the laboratory must be made of waterproof, flat, non-porous material;

- The laboratory bench must be made of waterproof, corrosion-resistant material, equipped with a sink and clean water faucet installed directly on the bench;

- There must be a waiting area for specimen collection, a receiving area for specimens, and a cleaning area for instruments;

- Laboratories conducting microbiological tests that pose a risk of infectious disease transmission to humans must comply with the legal requirements for biological safety in laboratories;

- HIV laboratories must operate in accordance with the legal regulations on HIV/AIDS prevention and control.

b) Ensure medical waste management and fire prevention and control in accordance with the law.

c) Ensure sufficient electricity, water, and other conditions necessary to serve patient care.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

Have sufficient testing equipment and medical supplies to perform the scope of professional activities registered by the facility, including at least sufficient equipment to perform one of the six types of microbiological, biochemical, hematological, immunological, pathological, and cytological, genetic tests.

3. Personnel:

a) Personnel working at the facility who conduct medical examinations and treatments must have a practice certificate and be assigned tasks that match their professional scope of work as stated in their practice certificate.

b) The person responsible for technical and professional management of the laboratory must meet the following conditions:

- Be a doctor or technician specializing in laboratory science, with a bachelor's degree or higher and a specialized practice certificate; or a bachelor's degree in chemistry, biology, or pharmacy for those hired as laboratory technicians before this Decree takes effect and granted a specialized practice certificate as a technician.

- Have at least 54 months of experience in specialized laboratory work or at least 36 months of experience in laboratory practice, including postgraduate studies in specialized laboratory work from the start of laboratory work (determined from the date of signing the labor contract or employment decision) until the date of appointment as the person responsible for technical and professional management of the laboratory.

- They must be permanent practitioners at the laboratory.

Article 29. Conditions for Issuing a Business License for Diagnostic Imaging Clinics and X-ray Rooms

1. Infrastructure:

a) Meeting the conditions stipulated in point a, Clause 2, Article 25 of this Decree and the following conditions according to the scope of registered specialized activities:

- For ultrasound rooms and diagnostic endoscopy rooms, they must be designed independently, with each room having an area of at least 10 square meters.²;

- For digestive endoscopy rooms, if both upper and lower digestive endoscopy techniques are performed, there must be two separate rooms, each with an area of at least 10 square meters.².

b) Ensuring radiation safety conditions, medical waste management, hazardous waste management (if applicable), and fire prevention and firefighting as prescribed by law.

3. Medical Equipment:

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

- Being a physician with a practice certificate corresponding to the specialty registered by the clinic.

b) Having personal protective equipment as prescribed by law on radiation safety.

3. Personnel:

a) If performing medical examination and treatment, personnel working at the facility must have a practice certificate and be assigned tasks consistent with the scope of specialized activities recorded in their practice certificate.

b) The person responsible for technical expertise in diagnostic imaging clinics must be a doctor with a practice certificate in diagnostic imaging specialty and have at least 54 months of direct experience in medical examination and treatment in the diagnostic imaging specialty; they must be a permanent practitioner at the diagnostic imaging clinic.

c) The person responsible for technical expertise in X-ray rooms must be a doctor specializing in diagnostic imaging or a radiology bachelor's degree holder or higher, holding a practice certificate and having at least 54 months of direct experience in radiology work. A radiology bachelor's degree holder (at the university level) can read and describe diagnostic images but cannot make diagnostic conclusions; they must be a permanent practitioner at the X-ray room.

Article 30. Conditions for Issuing a Business License for Maternity Homes

1. Infrastructure:

a) Meeting the conditions stipulated in point a, Clause 2, Article 25 of this Decree;

b) Functional rooms must be designed in a continuous and rational manner to facilitate emergency care, medical examination, and treatment;

c) There must be antenatal examination rooms, gynecological examination rooms, family planning technique rooms, each room must have an area of at least 10 square meters;²the delivery room must have an area of at least 16 square meters, must be arranged with a newborn corner; the lying room for pregnant women must have an area of at least 10 square meters.²In cases where the lying room for pregnant women has three or more beds, the minimum area for one bed must be 5 square meters.²d) Ensuring radiation safety conditions (if radiation equipment is used), medical waste management, and fire prevention and firefighting as prescribed by law;²;

a) Having sufficient medical equipment and tools appropriate to the scope of specialized activities registered by the maternity home;

đ) Ensure sufficient electricity, water, and other conditions necessary to serve patient care.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

b) Having sufficient emergency transport facilities within and outside the maternity home. In cases where there is no emergency transport facility outside the maternity home, a contract must be made with a medical examination and treatment facility that has been issued a business license and is permitted to provide emergency service and patient transportation support;

c) Having a shock box and sufficient specialized emergency medicines.

3. Organization and Personnel:

a) If performing medical examination and treatment, personnel working at the maternity home must have a practice certificate and be assigned tasks consistent with the scope of specialized activities recorded in their practice certificate.

b) The person responsible for technical expertise at the maternity home must meet the following conditions:

- Being a doctor specializing in obstetrics and gynecology or a midwife graduate with a practice certificate;

- Having at least 54 months of experience in medical examination and treatment in obstetrics and gynecology;

- Being a permanent practitioner at the maternity home.

4. In cases where the maternity home meets the conditions to provide pediatric specialist medical examination and treatment services as stipulated in Article 26 of this Decree and vaccine inoculation services as prescribed by law on inoculation, these services may be added to the scale and scope of specialized activities of the maternity home.

4. In cases where a midwife meets the conditions to provide pediatric specialist diagnosis and treatment services as stipulated in Article 26 of this Decree and vaccine inoculation as prescribed by laws on inoculation, such midwife may be included in the scale and scope of professional activities of the midwife.

Article 31. Conditions for Issuing a Permit to Operate a Clinic, Counseling, and Preventive Treatment

1. Scale:

The clinic, counseling, and preventive treatment have a scale equivalent to a general outpatient clinic or a specialized outpatient clinic depending on the legal basis for establishing these clinics.

2. Infrastructure:

In the case of a scale equivalent to a general outpatient clinic, the physical facilities must meet the conditions stipulated in Clause 2, Article 25 of this Decree. In the case of a scale equivalent to a specialized outpatient clinic, the physical facilities must meet the conditions stipulated in Clause 1, Article 26 of this Decree.

a) Having adequate medical equipment and instruments suitable for the hospital's professional scope;

Meeting the conditions regarding medical equipment suitable for a scale equivalent to a general outpatient clinic as stipulated in Clause 3, Article 25 or a scale equivalent to a specialized outpatient clinic as stipulated in Clause 2, Article 26 of this Decree.

4. Personnel:

a) If performing medical examination and treatment, personnel working at the facility must have a practice certificate and be assigned tasks consistent with the scope of specialized activities recorded in their practice certificate.

b) The person responsible for the technical expertise of the Clinic, Counseling, and Preventive Treatment must be a general practitioner with a practice certificate or a specialist physician with a relevant practice certificate and at least 54 months of experience in diagnosing and treating illnesses; they must be a permanent employee at the clinic.

5. If the clinic conducts vaccine inoculation or therapeutic product administration, it must comply with the legal regulations on inoculation.

Article 32. Conditions for Issuing a Permit to Operate a Clinic for Occupational Disease Diagnosis and Treatment

1. Scale:

The clinic for occupational disease diagnosis and treatment has a scale equivalent to a general outpatient clinic or a specialized outpatient clinic depending on the legal basis for establishing these clinics.

2. Infrastructure:

a) In the case of a scale equivalent to a general outpatient clinic, the physical facilities must meet the conditions stipulated in Clause 2, Article 25 of this Decree. In the case of a scale equivalent to a specialized outpatient clinic, the physical facilities must meet the conditions stipulated in Clause 1, Article 26 of this Decree;

b) Must have at least two testing departments (biochemistry, toxicology, microbiology) and diagnostic imaging.

a) Having adequate medical equipment and instruments suitable for the hospital's professional scope;

a) In the case of a scale equivalent to a general outpatient clinic, it must meet the conditions regarding medical equipment stipulated in Clause 3, Article 25 of this Decree. In the case of a scale equivalent to a specialized outpatient clinic, it must meet the conditions regarding medical equipment stipulated in Clause 2, Article 26 of this Decree;

b) Must meet the conditions regarding medical equipment for testing stipulated in Clause 2, Article 28, and the conditions regarding medical equipment for diagnostic imaging stipulated in Clause 2, Article 29 of this Decree.

4. Personnel:

a) Personnel working at the facility, if involved in diagnosing and treating illnesses, must have a practice certificate and a training certificate in occupational diseases, with job assignments appropriate to the scope of their professional activities as recorded in their practice certificates.

b) The person responsible for the technical expertise of the Clinic for Occupational Disease Diagnosis and Treatment must meet the following conditions:

- Be a specialist physician in occupational diseases with a practice certificate or a general practitioner with a practice certificate and a training certificate in occupational diseases;

- Have at least 54 months of experience in diagnosing and treating occupational diseases;

- Be a permanent employee at the clinic.

Article 33. Conditions for Issuing a Permit to Operate a Service Facility for Inoculation (Injection), Bandage Change, Pulse Counting, Temperature Measurement, and Blood Pressure Measurement

1. Infrastructure:

a) A fixed location with adequate lighting, separate from family living areas;

b) The inoculation (injection) room and bandage change room must have a minimum area of 10 square meters.²;

c) Adequate electricity, water, and other hygiene conditions to serve patient care.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

a) Must have sufficient medical equipment and tools appropriate to the scope of professional activities registered by the facility;

b) Must have an emergency drug kit.

3. Personnel:

a) Personnel working at the facility, if involved in diagnosing and treating illnesses, must have a practice certificate and job assignments appropriate to the scope of their professional activities as recorded in their practice certificates.

b) The person responsible for the technical expertise of the service facility for inoculation (injection), bandage change, pulse counting, temperature measurement, and blood pressure measurement must meet the following conditions:

- Be a graduate of a secondary-level medical program or higher with a practice certificate;

- Have at least 45 months of experience in diagnosing and treating inoculation (injection), bandage change, pulse counting, temperature measurement, and blood pressure measurement.

- Be a permanent employee at the facility.

Article 34. Conditions for Issuing an Operating Permit for Home Health Care Service Facilities

Home health care service facilities providing services such as changing dressings, removing sutures; physiotherapy, rehabilitation; mother and child care; blood sampling and test result delivery; cancer patient care and other nursing services at home must meet the following conditions:

1. Medical Equipment:

Must have sufficient medical equipment and tools appropriate to the scope of professional activities registered by the facility.

2. Personnel:

a) Personnel working at the facility who conduct medical examinations and treatments must have a practice certificate and be assigned tasks that match their professional scope of work as stated in their practice certificate.

b) The person responsible for technical and professional management of the home health care service facility must be a graduate of a medical vocational college or higher with a practice license and at least 45 months of experience in diagnosis and treatment.

- Be a permanent employee at the facility.

Article 35. Conditions for Issuing an Operating Permit for Emergency Services and Patient Transport Facilities

1. Infrastructure:

a) A fixed location with adequate lighting, separate from family living areas;

b) Ensure adequate electricity, water, and other hygiene conditions to serve patient care.

2. Medical Transport Equipment and Means:

a) Must have sufficient emergency transport means equipped with complete medical equipment and tools;

b) Must have a shock prevention kit and sufficient emergency medicines to ensure safety and hygiene conditions for patients.

3. Personnel:

a) If personnel working at the facility perform diagnosis and treatment, they must have a practice license and be assigned tasks consistent with the scope of professional activities recorded on their practice license.

b) The person responsible for technical and professional management of domestic and international emergency services and patient transport facilities must meet the following conditions:

- Be a doctor with a practice license;

- Hold a degree, certificate, or certification in emergency resuscitation specialty;

- Have at least 54 months of experience in diagnosis and treatment.

- Be a permanent employee at the facility.

4. Must have an emergency transport contract with an air service company if the facility registers for transporting patients abroad.

Article 36. Conditions for Issuing an Operating Permit for Optical Service Facilities

1. Infrastructure:

a) A fixed location with adequate lighting, separate from family living areas;

b) The facility must have an area of at least 15 square meters.²;

c) Ensure adequate electricity, water, and other hygiene conditions to serve patient care.

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

Must have sufficient medical equipment and tools appropriate to the scope of professional activities registered by the facility.

3. Personnel:

a) Personnel practicing at optical service facilities must have a practice license in ophthalmology or refractive error measurement and diagnosis and be assigned tasks consistent with the scope of professional activities recorded on their practice license.

b) The person responsible for technical and professional management of optical service facilities:

- Must hold a medical vocational college degree or higher with a practice license in ophthalmology or refractive error measurement and diagnosis;

- Must have at least 36 months of professional practice in ophthalmology at a diagnosis and treatment facility or refractive error measurement and diagnosis at an optical service facility.

- Must be a permanent practitioner at the optical service facility;

Article 37. Conditions for Operating Aesthetic Service Facilities

1. Aesthetic service facilities may only carry out tattooing, cosmetic injection, embroidery activities on the skin without using injectable anesthesia and must meet the following conditions:

- Having an emergency resuscitation room;

- Have a fixed location;

- Ensure hygiene conditions.

b) Equipment:

Must have sufficient equipment, tools, and materials appropriate to the scope of operations of the facility and with clear origin.

c) Personnel:

Personnel performing tattooing, cosmetic injection, embroidery on the skin without using injectable anesthesia at aesthetic service facilities must have a training or vocational qualification certificate issued by a legitimate training or vocational institution.

d) Aesthetic service facilities that do not require an operating permit but must submit a notification document meeting the conditions specified in points a, b, and c of this clause to the Department of Health where the headquarters is located for management at least 10 days before commencing operations. The notification document follows the model prescribed in Appendix VIII attached to this Decree.

2. Aesthetic services using drugs, substances, and equipment to intervene in the human body (surgery, procedures, interventions involving injections, punctures, infusions, radiation, waves, cauterization, or other invasive interventions) to change skin color, shape, weight, defects of body parts (skin, nose, eyes, lips, face, chest, abdomen, buttocks, and other body parts), tattooing, cosmetic injection, embroidery on the skin using injectable anesthesia can only be performed at hospitals with an aesthetic specialty department or specialized aesthetic clinics or diagnosis and treatment facilities with a professional scope of activities in aesthetic specialties approved by competent authorities.

Article 38. Conditions for operating massage service facilities

1. Infrastructure:

a) Fixed location, with adequate lighting, separated from family living areas.

b) Massage rooms must meet the following conditions:

- Each massage room must have an emergency bell arranged in such a way that it can be activated from the massage room to the doctor's room or reception area;

- There must be a large print technical massage procedure chart, easily readable, posted or hung on the wall of the massage room on A1 size paper.

c) There must be a hygienic bathroom, ensuring sufficient electricity, water, and other hygiene conditions to care for customers.

2. Equipment:

a) Must have suitable massage beds, chairs, or mats; bed sheets, pillows, and towels must be clean;

b) Must have examination beds, emergency medicine cabinets, work desks, and some medical equipment (stethoscope, blood pressure monitor, thermometer, syringe pump) in the doctor's duty room;

c) Must have common emergency medicines.

3. Personnel:

a) The person responsible for technical expertise at the massage service facility must be a doctor or a physician or a technician in one of the rehabilitation, physiotherapy, or traditional medicine fields, or hold a specialized training certificate in rehabilitation, physiotherapy, or traditional medicine. In cases where medication is prescribed, the person responsible for technical expertise must be a doctor specializing in rehabilitation, physiotherapy, or traditional medicine;

b) If staff working at the facility perform massage techniques, they must have a certificate or training completion document for massage issued by a legitimate training institution.

Staff performing massage techniques must wear neat, clean, and appropriate uniforms with badges clearly indicating the facility name, staff name, and a 3 cm x 4 cm photograph.

4. Massage service facilities not requiring a business license must submit a notification document meeting the conditions stipulated in Clauses 1, 2, and 3 of this Article to the Health Department at the location of their headquarters for management within ten days before commencing operations. The notification document shall follow the model specified in Appendix IX attached to this Decree.

Article 39. Conditions for Issuing Business Licenses for Commune Health Stations and Clinics

1. Infrastructure:

a) Must comply with design regulations set forth by the Minister of Health;

b) Must meet safety radiation, medical waste disposal, and fire prevention and extinguishing conditions as prescribed by law;

3. Medical Equipment:

a) The person responsible for technical expertise of the specialty outpatient clinic must meet the following conditions:

- Being a physician with a practice certificate corresponding to the specialty registered by the clinic.

b) Must have an emergency drug kit.

3. Personnel:

a) The person responsible for technical expertise must satisfy the following conditions:

- Be a doctor or physician holding a practice certificate;

- Have at least 54 months of experience in diagnosis and treatment for doctors and 45 months for physicians.

b) The number of practitioners at commune health stations must meet the staffing standards for public health institutions as prescribed by law.

c) Village health workers must provide primary healthcare according to the division of labor and professional guidance from the Commune Health Station Director.

4. For cases where Commune Health Stations conduct diagnosis and treatment based on family medicine principles, they must follow the pilot guidelines issued by the Minister of Health.

Article 40. Scope of Professional Activities for Medical Examination and Treatment Facilities

Based on the organizational form and conditions for issuing business licenses for medical examination and treatment facilities as stipulated in this Decree, the Minister of Health will define the scope of professional activities for each organizational form of medical examination and treatment facilities, except for aesthetic service facilities and massage service facilities.

Article 41. Provisions on the Content of Signboards for Medical Examination and Treatment Facilities

After being granted a permit to operate, medical examination and treatment facilities must have signboards in accordance with the provisions of the law on signboards, not using the red cross symbol on the signboard, and must include the following basic information:

1. The full name of the facility and the number of the permit for medical examination and treatment.

2. The address of the facility as recorded in the permit for medical examination and treatment; telephone number.

3. Daily operating hours.

Section 2. AUTHORITY, FILES, PROCEDURES FOR GRANTING, REISSUING, AND AMENDING THE PERMIT TO OPERATE FOR MEDICAL EXAMINATION AND TREATMENT FACILITIES

Article 42. Authority to Grant, Reissue, and Amend the Permit to Operate for Medical Examination and Treatment Facilities

1. The Minister of Health shall grant, reissue, and amend the permit to operate for medical examination and treatment facilities in accordance with Clause 1 of Article 45 of the Law on Medical Examination and Treatment.

2. The Director of the Department of Health shall grant, reissue, and amend the permit to operate for medical examination and treatment facilities in accordance with Clause 2 of Article 45 of the Law on Medical Examination and Treatment.

Article 43. Files for Requesting the Granting, Reissuing, Amending the Permit to Operate, Changing the Person Responsible for Professional Management, Announcing the Facility's Compliance with Conditions for Conducting Health Examinations

1. The file for requesting the granting of the permit to operate for medical examination and treatment facilities as stipulated in Clause 1 of Article 46 of the Law on Medical Examination and Treatment is detailed as follows:

a) A request form for the permit to operate according to Model 01 of Appendix XI issued together with this Decree;

b) A certified true copy of the decision on establishment or the document bearing the name of the medical examination and treatment facility issued by the competent state agency for state-owned medical examination and treatment facilities or the business registration certificate for private medical examination and treatment facilities or the investment certificate for medical examination and treatment facilities with foreign capital;

c) A certified true copy of the practice certificate of the person responsible for professional technical management of the medical examination and treatment facility; the person in charge of the specialized department of the medical examination and treatment facility;

d) A list of registered practitioners at the medical examination and treatment facility (including registered practitioners and health care workers at the facility who are not required to obtain a practice certificate) according to the model prescribed in Appendix IV issued together with this Decree;

đ) An inventory of physical infrastructure, medical equipment, organization, and personnel of the medical examination and treatment facility according to Model 02 of Appendix XI issued together with this Decree;

e) Documents proving that the medical examination and treatment facility meets the conditions regarding physical infrastructure, medical equipment, organizational personnel suitable to the scope of professional activities of one of the forms of organization prescribed in Section 1 Chapter III of this Decree;

g) Bylaws on organization and operation for state hospitals implemented according to the model prescribed by the Minister of Health; for private hospitals implemented according to Model 03 of Appendix XI issued together with this Decree and initial operational plans for hospitals;

h) A certified true copy of the patient transport contract for hospitals and maternity homes without their own emergency transport means;

i) A list of specialized technical services offered by the medical examination and treatment facility proposed based on the list of specialized technical services issued by the Minister of Health;

k) For emergency service facilities and patient transportation support services: A certified true copy of the contract for professional support with hospitals. In cases where they provide patient transportation services abroad, there must be a certified true copy of the patient transportation contract with an air service company.

2. The file for requesting the granting of the permit to operate for medical examination and treatment facilities when changing the form of organization, splitting, merging, or consolidating shall be carried out in accordance with the provisions of Clause 1 of this Article.

3. The file for requesting the granting of the permit to operate for medical examination and treatment facilities when changing location:

a) A request form for the permit to operate according to Model 04 of Appendix XI;

b) Relevant documents as stipulated in Clause 1 of this Article (if there are changes compared to the previous location's files).

4. The file for requesting the granting of the permit to operate for medical examination and treatment facilities when changing the name of the medical examination and treatment facility:

a) A request form for the permit to operate according to Model 05 of Appendix XI;

b) Relevant documents as stipulated in Clause 1 of this Article (if there are changes compared to previous files).

5. The file for requesting the amendment of the content of the permit to operate for medical examination and treatment facilities when changing the scale of hospital beds or organizational structure or scope of professional activities shall be carried out in accordance with the provisions of Clause 3 of Article 46 of the Law on Medical Examination and Treatment, including:

a) A request form according to Model 06 of Appendix XI issued together with this Decree;

b) An inventory of physical infrastructure, medical equipment, organization, and personnel corresponding to the expected scale or scope of professional activities to be adjusted according to Model 02 of Appendix XI issued together with this Decree.

6. The file for requesting the change of the person responsible for professional management of medical examination and treatment facilities:

a) A request form according to Model 07 of Appendix XI issued together with this Decree;

b) The decision to dismiss the person previously responsible for professional management of the facility;

c) The decision to appoint the person responsible for professional management of the medical examination and treatment facility;

d) A certified true copy of the practice certificate of the newly appointed person responsible for professional management of the medical examination and treatment facility;

đ) Employment contract or recruitment decision of the newly appointed person responsible for professional management of the medical examination and treatment facility;

e) Certificate confirming three years of practice after obtaining the practice certificate according to Model 10 of Appendix XI issued together with this Decree;

g) Original permit to operate of the medical examination and treatment facility already issued.

7. The file for requesting the reissuance of the permit to operate for medical examination and treatment facilities lost, damaged, or revoked according to point a of Clause 1 of Article 48 of the Law on Medical Examination and Treatment includes:

a) A request form according to Model 08 of Appendix XI issued together with this Decree;

b) Original damaged permit (if applicable).

8. The file for announcing compliance with conditions for conducting health examinations:

a) A declaration of compliance with conditions for conducting health examinations according to Model 01 of Appendix X issued together with this Decree;

b) A certified true copy of the permit to operate for medical examination and treatment of the facility.

c) A list of individuals participating in health examinations according to Form 02 Appendix X issued together with this Decree;

d) An inventory of facilities, medical equipment, organizational structure, and personnel of the healthcare facility according to Form 02 Appendix XI issued together with this Decree;

đ) A valid copy of the technical specialty catalog of the healthcare facility;

e) A valid copy of the professional support contract of the hospital (if any).

Article 44. Procedures for issuing, reissuing, amending the operating permit, changing the person responsible for professional matters at healthcare facilities, and announcing the eligibility to conduct health examinations

1. The application dossier for issuing, reissuing, amending the operating permit, and changing the person responsible for professional matters at healthcare facilities as stipulated in Article 43 of this Decree shall be compiled into one set and submitted to the competent authority as follows:

a) The Ministry of Health for the application dossier for issuing the operating permit of healthcare facilities under the Ministry of Health, private hospitals, or hospitals under other ministries;

b) The Provincial Department of Health for the application dossier for issuing the operating permit of healthcare facilities within their jurisdiction, except for those specified in point a of this clause.

2. The procedure for reviewing applications for issuing, reissuing, amending the operating permit, and changing the person responsible for professional matters at healthcare facilities shall be carried out as follows:

a) After receiving the application dossier for issuing, reissuing, or amending the operating permit, the Ministry of Health or the Provincial Department of Health (hereinafter referred to as the dossier receiving agency) shall proceed as follows:

- In cases where the dossier is submitted directly to the dossier receiving agency, upon receipt of the dossier, the agency shall immediately send the healthcare facility applying for the operating permit a Dossier Receipt Form according to Form 09 Appendix XI issued together with this Decree;

- In cases where the dossier is sent through postal service, within three days from the date of receipt of the dossier (based on the postmark), the agency shall send the healthcare facility applying for the operating permit a Dossier Receipt Form according to Form 09 Appendix XI issued together with this Decree.

b) If the dossier is valid, the dossier receiving agency must review and issue, reissue, or amend the operating permit within sixty days for hospitals and forty-five days for other forms of healthcare organizations, starting from the date recorded on the Dossier Receipt Form. If the operating permit is not issued, reissued, or amended, a written response must be provided with clear reasons.

c) If the application dossier for the operating permit is incomplete, the dossier receiving agency must notify the healthcare facility applying for the operating permit to complete the dossier within ten working days from the date recorded on the Dossier Receipt Form. The notification must specify which documents need to be supplemented and which contents need to be revised;

- Upon receiving the request to complete the dossier, the healthcare facility applying for the issuance, reissuance, amendment of the operating permit, or change of the person responsible for professional matters must supplement and revise the dossier according to the contents specified in the notification and submit it back to the dossier receiving agency;

- Within ten working days from the date of receipt of the supplementary and revised dossier, if the dossier receiving agency does not issue a request for further revision or supplementation, they must issue, reissue, or amend the operating permit within the time limit specified in point b of this clause; if not, a written response must be provided with clear reasons;

- After sixty days from the date the dossier receiving agency issues a request for supplementation or revision, if the healthcare facility applying for the operating permit fails to supplement or revise the dossier, or if the supplementation or revision does not meet the requirements, the entire application process must be restarted.

3. The operating permit shall be issued by the Minister of Health or the Director of the Provincial Department of Health according to the form prescribed in Appendix XII. The operating permit number shall be based on the code system specified in Form 04 Appendix III issued together with this Decree.

4. Procedures for announcing eligibility to conduct health examinations:

Before conducting the first health examination, the healthcare facility must submit the announcement dossier of eligibility to conduct health examinations as stipulated in Clause 8, Article 43 of this Decree to the competent state management agency in the field of health (submitting directly or sending via postal service), specifically as follows:

a) For healthcare facilities under the Ministry of Health: The dossier shall be submitted to the Department of Medical Examination and Treatment - Ministry of Health;

b) For healthcare facilities under the management of the Ministry of Public Security: The dossier shall be submitted to the Public Security Ministry's Health Department; for healthcare facilities under the management of the Ministry of Transport: The dossier shall be submitted to the Department of Health of the Ministry of Transport;

c) For healthcare facilities under the management of the Provincial Department of Health (excluding those specified in points a and b of this clause): The dossier shall be submitted to the Provincial Department of Health where the healthcare facility is located.

5. Procedure for processing the announcement dossier of eligibility to conduct health examinations:

a) Upon receipt of the announcement dossier of eligibility to conduct health examinations, the state management agency in the field of health as stipulated in Clause 4 of this Article (hereinafter referred to as the dossier receiving agency) shall send the healthcare facility announcing eligibility to conduct health examinations (hereinafter referred to as the eligible facility) a Dossier Receipt Form according to Form 3 Appendix X issued together with this Decree. If the dossier is incomplete or invalid as stipulated in Clause 8, Article 43, the dossier receiving agency must issue a written notice to the eligible facility requesting supplementation or completion of the dossier. After the eligible facility supplements or completes the dossier, the dossier receiving agency shall continue to send the eligible facility a Dossier Receipt Form according to Form 3 Appendix X issued together with this Decree.

a) Upon receipt of the declaration dossier meeting the conditions for conducting health examinations, the state management agency for health care specified in Clause 4 of this Article (hereinafter referred to as the dossier receiving agency) shall send to the medical facility declaring its qualification to conduct health examinations (hereinafter referred to as the qualified declaration facility) a Dossier Receipt Form according to Model 3 of Appendix X issued together with this Decree. In cases where the dossier does not meet the completeness and validity requirements as stipulated in Clause 8 of Article 43, the dossier receiving agency must issue a written request to the qualified declaration facility to supplement and complete the dossier. After the qualified declaration facility supplements and completes the dossier, the dossier receiving agency shall continue to send to the qualified declaration facility a Dossier Receipt Form according to Model 3 of Appendix X issued together with this Decree.

b) In case the file is complete and valid according to Clause 8, Article 43, the agency receiving the file does not issue a request for supplementary or improved information. Within fifteen working days from the date of receipt of the Receipt Form, the entity that has been declared eligible may commence its health examination activities within the scope of expertise already announced.

c) Where there is a change in the name, address, infrastructure conditions, personnel, and scope of expertise of an entity that has been declared eligible to conduct health examinations, such entity shall notify the agency that received the declaration file in writing.

Article 45. Organization for the assessment to issue, reissue, or adjust the operating permit for medical examination and treatment facilities

1. The Minister of Health and the Director of the Department of Health shall establish an assessment team to issue, reissue, or adjust the operating permit for medical examination and treatment facilities within their respective authority.

2. The assessment team shall carry out the assessment within the time limit stipulated in Point b, Clause 2, Article 44 of this Decree and must prepare an assessment record according to the model prescribed in Appendix XIII attached to this Decree.

Assessment records of medical examination and treatment facilities under the management authority of the Minister of Health shall be made in three copies: one copy retained at the Ministry of Health, one copy retained at the Department of Health where the medical examination and treatment facility is located, and one copy retained at the assessed medical examination and treatment facility.

Assessment records of medical examination and treatment facilities under the management authority of the Director of the Department of Health shall be made in two copies; one copy retained at the Department of Health, and one copy retained at the assessed medical examination and treatment facility.

3. Management of the operating permit:

a) Each medical examination and treatment facility shall only be issued one operating permit. If a medical examination and treatment facility operates from multiple locations, each location must meet the conditions stipulated in Article 23 of this Decree and shall be issued a separate operating permit.

b) A valid copy of the operating permit and the application file for issuing, reissuing, or adjusting the operating permit shall be kept by the issuing agency.

c) After issuing, reissuing, or adjusting the operating permit for a medical examination and treatment facility, the issuing agency shall undertake the following procedures:

- The Ministry of Health shall send a notification letter to the People's Committee of the province and the Department of Health where the medical examination and treatment facility has been granted the operating permit is located within thirty days from the date of issuance, reissuance, or adjustment of the operating permit;

- The Department of Health shall send a notification letter to the People's Committee of the district, town, city under the province (district level) and the district health office where the medical examination and treatment facility has been granted the operating permit is located within thirty days from the date of issuance, reissuance, or adjustment of the operating permit;

- The Ministry of Health shall publish a list of medical examination and treatment facilities that have been issued, reissued, or had their operating permits adjusted within its authority on the Ministry of Health's official website. The Department of Health shall publish a list of medical examination and treatment facilities that have been issued, reissued, or had their operating permits adjusted within its authority on the Department of Health's official website.

Chapter IV

ISSUANCE OF PRACTICE CERTIFICATES AND OPERATING PERMITS FOR ONLINE MEDICAL EXAMINATION AND TREATMENT

Article 46. Requirements for the registration dossier, application for issuance, reissuance of practice certificates, issuance, reissuance, and adjustment of permits for online medical examination and treatment activities

The registration dossier, application for issuance, reissuance of practice certificates, issuance, reissuance, and adjustment of permits for online medical examination and treatment activities (hereinafter referred to as the online registration dossier) shall be considered valid when it meets the following requirements:

1. It must contain all required documents and papers as prescribed, with complete contents filled out according to the regulations applicable to paper-based dossiers and converted into electronic text format. The name of the electronic document must correspond to the type of paper document in the paper-based dossier.

2. All information for the application for issuance, reissuance of practice certificates, issuance, reissuance, and adjustment of permits for medical examination and treatment activities must be fully and accurately entered based on the information in the original documents.

Article 47. Procedure for online registration

1. The individual submitting the dossier or their legal representative must declare the information, upload the electronic document, confirm the submission of the online registration dossier with a digital signature, and pay the fee through the Ministry of Health's Electronic Portal or the Department of Health's Website.

In cases where a digital signature is not used to confirm the dossier, the organization or individual applying for online registration must scan the paper dossier and send it along to the registration system for review and verification by the receiving authority.

2. After completing the submission of the online registration dossier, the online dossier receiving authority shall issue an Online Dossier Receipt to the dossier submitter.

3. The online dossier receiving authority shall carry out administrative procedures corresponding to the provisions set forth in Chapter II and Chapter III of this Decree.

4. The result of the online administrative procedure is a document signed by the authority or an electronic document with a digital signature confirming receipt of the dossier, which has the same legal effect as the result of an administrative procedure resolved through conventional means.

5. The Minister of Health shall guide the implementation of the issuance, reissuance of practice certificates, issuance, reissuance, and adjustment of permits for online medical examination and treatment activities.

Article 48. Storage of online registration dossiers

1. In cases where online registration is carried out, the registration entity must retain the paper version of the registration dossier for inspection and verification when necessary.

2. In cases where the documents in the registration dossier specified in Clause 1 of this Article are lost or damaged, the individual, organization applying for registration, and the dossier receiving authority shall be responsible for implementing the following procedures:

a) The individual, organization applying for registration must notify the dossier receiving authority in writing and complete the dossier; notify the dossier receiving authority in writing after completing the dossier again; only proceed to update the dossier after obtaining the consent of the dossier receiving authority;

b) Within sixty days from the date the dossier receiving authority receives notification of the loss of the dossier, if the individual, organization applying for registration does not provide a written notification that the dossier has been completed again, then the dossier receiving authority shall be responsible for removing the relevant information posted on the Ministry of Health's Electronic Portal or the Department of Health's Website concerning the issued practice certificate and permit for medical examination and treatment activities;

c) Revoke the issued practice certificate and permit for medical examination and treatment activities;

d) The practitioner may not continue practicing, and the medical examination and treatment facility may not continue operating from the time the dossier receiving authority removes the information as stipulated in point b, clause 2 of this Article.

Chapter V

IMPLEMENTING PROVISIONS

Article 49. Effective Date

1. This Decree takes effect from July 1, 2016.

2. Article 3 of Decree No. 87/2011/ND-CP dated September 27, 2011, detailing certain provisions of the Law on Medical Examination and Treatment shall cease to be effective from the date this Decree takes effect. Any previous provisions contrary to this Decree shall be abolished.

Article 50. Transitional Provisions

1. In cases where organizations and individuals submit applications for issuance, reissuance of practice certificates, issuance, reissuance, and adjustment of permits before the effective date of this Decree, they shall follow the legal regulatory documents issued prior to the effective date of this Decree.

2. Individuals and organizations providing aesthetic services as stipulated in Clause 1 of Article 37 and massage services as stipulated in Article 38 of this Decree must ensure compliance with the conditions and procedures prescribed in this Decree within twelve months from the date this Decree takes effect.

3. Occupational disease clinics; HIV/AIDS clinics; specialized nutrition clinics; drug rehabilitation support clinics currently in operation before the effective date of this Decree shall continue operations and must complete the procedures to obtain a permit for operation before June 30, 2017.

4. Dental prosthetic service facilities already regulated in legal regulatory documents on private medical and pharmaceutical practices before the effective date of this Decree shall only be granted a permit for operation if they meet the following conditions:

- Having an emergency resuscitation room;

- Have a fixed location;

- Ensuring conditions for medical waste management and fire prevention and control in accordance with the law;

- Ensuring sufficient electricity, water, and other conditions to serve patient care;

- The dental clinic and prosthetic fitting room must have an area of at least 10 square meters;²;

- The dental prosthetic room must have an area of at least 10 square meters;²in cases where there is no dental prosthetic room, a contract must be signed with another dental prosthetic facility.

b) Medical equipment: Must have sufficient medical equipment and tools suitable for the scope of professional activities registered by the facility.

c) Human resources: The person responsible for professional matters must be a dentist who has practiced since 1980 or earlier (not granted to other categories), holding a confirmation letter from the People's Committee of the commune in the format prescribed in Appendix XIV attached to this Decree, and having obtained a certificate of qualification for practice or a permit for operation of a dental prosthetic service facility or a dental prosthetic room in accordance with the law on private medical and pharmaceutical practices.

Article 51. Responsibility for Implementation

1. The Minister of Health shall be responsible for guiding the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial and centrally-administered city People's Committees are responsible for implementing this Decree./.