Circular No. 41/2011/TT-BYT guides the issuance of practice certificates for healthcare practitioners and operating permits for medical examination and treatment facilities.

CIRCULAR

Guidelines for issuing practice certificates to practitioners and operating permits to medical examination and treatment facilities

for medical examination and treatment facilities

_____________________

 

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

Pursuant to Decree No. 87/2011/ND-CP dated September 27, 2011 of the Government detailing and guiding the implementation of certain articles of the Law on Medical Examination and Treatment;

Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

The Ministry of Health issues guidelines for issuing practice certificates to practitioners and operating permits to medical examination and treatment facilities as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides the following matters:

1. Issuing and reissuing practice certificates for practitioners engaged in medical examination and treatment (hereinafter referred to as practitioners), including:

a) Documents and procedures for issuing and reissuing medical examination and treatment practice certificates (hereinafter referred to as practice certificates);

b) Confirmation of practical experience;

c) Criteria for recognizing proficiency in Vietnamese or sufficient proficiency in another language or sufficient proficiency in medical interpretation;

d) Organization of issuing and reissuing practice certificates.

2. Issuing, reissuing, and amending operating permits for medical examination and treatment facilities, including:

a) Specific conditions for issuing operating permits for different forms of organization of medical examination and treatment facilities;

b) Competence, documents, and procedures for issuing, reissuing, and amending operating permits for medical examination and treatment facilities;

c) Organization of issuing, reissuing, and amending operating permits for medical examination and treatment facilities.

Article 2. Applicability

This Circular applies to practitioners and medical examination and treatment facilities throughout the country, except for practitioners and medical examination and treatment facilities under the management authority of the Ministry of National Defense.

Article 3. Explanation of Terms

1. Time spent on medical examination and treatment for issuance of a practice certificate is the time directly spent on medical examination and treatment or caring for patients from the date such person begins performing medical examination and treatment activities after obtaining a specialized degree (determined from the date of signing a labor contract or having a recruitment decision) until the date of application for issuance of a practice certificate (including time spent studying postgraduate or advanced studies in the specialized field for which the practice certificate is applied for).

2. Time spent on medical examination and treatment for serving as a person responsible for professional technical matters or head of a department, section, or specialized unit (hereinafter referred to as department) is the time directly spent on medical examination and treatment or caring for patients from the date such person begins performing medical examination and treatment activities after obtaining a specialized degree (determined from the date of signing a labor contract or having a recruitment decision) until the date of being assigned or appointed as a person responsible for professional technical matters or head of a department (including time spent studying postgraduate or advanced studies in the specialized field for which the person is assigned or appointed).

3. Full-time worker is a person working during the entire operational period registered by the medical examination and treatment facility, for example:

- For a hospital that registers its operational hours as 24 hours/day and 7 days/week, a full-time worker at the hospital must work the full administrative operational hours of the hospital excluding rest days and holidays and excluding on-call shifts;

- For a multi-specialty clinic that registers its operational hours from 08:00 to 16:00 and 7 days/week, a full-time worker at the clinic must work the full hours from 08:00 to 16:00 every day, excluding rest days and holidays.

Article 4. Principles for guiding and applying laws

1. This Circular guides the provisions of Articles, Clauses, and Points stipulated in the Law on Medical Examination and Treatment and Decree No. 87/2011/ND-CP dated September 27, 2011 of the Government detailing and guiding the implementation of certain provisions of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 87/2011/ND-CP), which delegate the Minister of Health to guide their implementation, and other issues related to issuing and reissuing practice licenses for practitioners; issuing, reissuing, and adjusting permits for medical examination and treatment facilities.

2. In addition to applying the Law on Medical Examination and Treatment, Decree No. 87/2011/ND-CP, and this Circular, practitioners and medical examination and treatment facilities must also comply with regulations on pharmaceuticals, commerce, enterprises, investment, advertising, and other relevant legal documents.

3. The collection and use of fees for issuing, reissuing practice licenses; issuing, reissuing, and adjusting permits for medical examination and treatment facilities; issuing certificates of proficiency in Vietnamese or certificates of proficiency in another language or certificates of proficiency in medical interpreting; issuing permits for educational institutions meeting the conditions to test and recognize proficiency in Vietnamese or proficiency in another language or proficiency in medical interpreting according to the regulations of the Ministry of Finance.

Chapter II

REGULATIONS ON ISSUING AND REISSUING PRACTICE LICENSES

Section 1

APPLICATION PROCEDURES FOR ISSUING AND REISSUING PRACTICE LICENSES

Article 5. Application dossier for issuing and reissuing practice licenses for Vietnamese nationals Male

1. The application dossier for issuing a practice license for Vietnamese nationals shall be carried out in accordance with Clause 1, Article 27 of the Law on Medical Examination and Treatment, specifically as follows:

a) An application form for issuing a practice license according to Model 01 prescribed in Appendix 01 attached hereto and two photographs measuring 04 x 06 cm taken against a white background within six months prior to the date of submission;

b) A certified copy of the diploma or certificate of professional qualifications for a traditional medicine practitioner or a certificate of family herbal remedies or family treatment methods issued by the Minister of Health or the Director of the Department of Health of a province (hereinafter referred to as the provincial level);

c) A certificate of practical experience;

d) A curriculum vitae with confirmation from the People's Committee of the commune, ward, town (hereinafter collectively referred to as the commune) where the applicant resides or confirmation from the head of the workplace;

đ) A criminal record certificate (only applicable when the Minister of Justice has guidelines for implementation according to the Criminal Record Law);

2. The application dossier for reissuing a practice license for those who have lost, damaged, or had their practice license revoked according to Point a and b, Clause 1, Article 29 of the Law on Medical Examination and Treatment: An application form for reissuing a practice license according to Model 01 prescribed in Appendix 02 attached hereto and two photographs measuring 04 x 06 cm taken against a white background within six months prior to the date of submission.

3. The application dossier for reissuing a practice license in cases where it has been revoked according to Points c, d, đ, e, and g, Clause 1, Article 29 of the Law on Medical Examination and Treatment includes:

a) An application form for issuing a practice license according to Model 02 prescribed in Appendix 02 attached hereto and two photographs measuring 04 x 06 cm taken against a white background within six months prior to the date of submission;

b) All documents specified in Clause 1 of this Article, except for the certificate of practical experience;

c) A certificate of continuous medical knowledge update in accordance with the regulations of the Ministry of Health.

Article 6. Documents for Application to Issue or Reissue Professional Practice Certificates for Foreign Nationals and Overseas Vietnamese Male 定居国外

1. Documents for Application to Issue a Professional Practice Certificate for foreign nationals and overseas Vietnamese shall be implemented in accordance with Clause 2, Article 27 of the Law on Medical Examination and Treatment, specifically as follows:

a) An application form for issuance of a professional practice certificate according to Model 02 prescribed in Appendix 01 attached hereto and two photographs measuring 04 x 06 cm taken against a white background within six months from the date of submission;

b) A certified copy of the professional qualification certificate;

c) A certificate of practical experience;

d) A certified copy of the certificate of proficiency in Vietnamese language.

In case the applicant does not have a certificate of proficiency in Vietnamese language, they must have an interpreter to interpret from their registered language to Vietnamese.

In case the applicant registers to use a language other than their native language for medical examination and treatment, they must have a certificate of proficiency in that language and must have an interpreter to interpret from that language to Vietnamese.

The interpreter must have a certificate of qualification for interpreting corresponding to the language registered by the foreign national for medical examination and treatment and must have a labor contract with the medical facility where the foreign national works;

d) A certified copy of the work permit issued by the competent authority of Vietnam for labor affairs;

e) Where the documents specified in Points b, c, and d of Clause 1 of this Article are issued by a foreign organization, they must be legalized and translated into Vietnamese, and the translation must be certified in accordance with Vietnamese law.

2. Documents for Application to Reissue a Professional Practice Certificate for foreign nationals and overseas Vietnamese whose certificates have been lost, damaged, or revoked in accordance with Point a and b of Clause 1, Article 29 of the Law on Medical Examination and Treatment: An application form for reissuance of a professional practice certificate according to Model 03 prescribed in Appendix 02 attached hereto and two photographs measuring 04 x 06 cm taken against a white background within six months from the date of submission.

3. Documents for Application to Reissue a Professional Practice Certificate for foreign nationals and overseas Vietnamese in cases where the certificate has been revoked in accordance with Points c, d, đ, e, and g of Clause 1, Article 29 of the Law on Medical Examination and Treatment include:

a) An application form for reissuance of a professional practice certificate according to Model 03 prescribed in Appendix 02 attached hereto; two photographs measuring 04 x 06 cm taken against a white background within six months from the date of submission;

b) The documents specified in Points b, c, d, đ, and e of Clause 1 of this Article.

Article 7. Procedures for Issuing and Reissuing Professional Practice Certificates

1. Documents for Application to Issue and Reissue Professional Practice Certificates as stipulated in Articles 5 and 6 of this Circular shall be carried out as follows:

a) Applicants for issuance and reissuance of professional practice certificates under the jurisdiction prescribed in Clause 1, Article 26 of the Law on Medical Examination and Treatment shall submit one set of documents to the Department of Medical Examination and Treatment - Ministry of Health;

b) Applicants for issuance and reissuance of professional practice certificates under the jurisdiction prescribed in Clause 2, Article 26 of the Law on Medical Examination and Treatment shall submit one set of documents to the Provincial Department of Health.

2. Procedure for Reviewing Applications for Issuance and Reissuance of Professional Practice Certificates

a) After receiving the application documents for issuance and reissuance of professional practice certificates, the Ministry of Health or the Provincial Department of Health (hereinafter referred to as the receiving agency) shall send the applicant a receipt for the documents according to Model 03 prescribed in Appendix 03 attached hereto;

b) Within the time limit prescribed in Clauses 2 and 3, Article 28 of the Law on Medical Examination and Treatment from the date recorded on the receipt, the Secretariat as prescribed in Article 9 of this Circular must conduct a review of the documents. If there is no request for additional information, it must be submitted to the head of the receiving agency for issuance and reissuance of the professional practice certificate; if not issued or reissued, a written response must be provided with specific reasons;

c) In case the application documents for issuance and reissuance of professional practice certificates are incomplete, within ten working days from the date recorded on the receipt, the receiving agency must notify the applicant in writing to complete the documents. The notification must specify which documents need to be supplemented and what contents need to be modified;

d) Upon receiving the notification requesting completion of the documents, the applicant must modify and supplement the documents in accordance with the contents specified in the notification and resubmit them to the receiving agency. The date of receipt of the supplementary documents will be recorded on the receipt. If the receiving agency does not issue a notification requesting modification or supplementation, the professional practice certificate must be issued or reissued within the time limit prescribed in Point b of Clause 2 of this Article;

đ) In case the applicant has supplemented the documents but not in accordance with the requirements, the receiving agency will notify the applicant to continue completing the documents in accordance with Points c and d of Clause 2 of this Article.

3. The professional practice certificate shall be issued or reissued by the Minister of Health or the Director of the Provincial Department of Health according to the model prescribed in Appendix 04 and according to the code number prescribed in Appendix 05 attached hereto, and each individual can only be issued one professional practice certificate. The blank professional practice certificates are managed and supplied by the Ministry of Health.

4. Copies of the professional practice certificate and the application documents for issuance and reissuance of the professional practice certificate shall be kept at the issuing agency.

Section 2

ORGANIZATION OF ISSUING AND REISSUING PROFESSIONAL PRACTICE CERTIFICATES

Article 8. Advisory Board for Issuing, Reissuing Professional Practice Certificates

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

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

3. Members of the Advisory Board shall perform tasks assigned by the Chairman of the Advisory Board and shall be provided with relevant materials related to the implementation of tasks prescribed in Clause 4, Article 28 of the Law on Medical Examination and Treatment.

Article 9. Secretariat for Reviewing Applications for Issuing, Reissuing Professional Practice Certificates

1. The Minister of Health shall establish a Secretariat to assist the Minister of Health in reviewing applications for issuing, reissuing professional practice certificates, consisting of the following components:

a) A representative from the Directorate General of Medical Examination and Treatment serving as the Head of the Secretariat;

b) A representative from the Department of Traditional Medicine serving as the Deputy Head of the Secretariat;

c) A representative of the Legal Affairs Department;

d) A representative from the Department of Science and Training;

đ) Other relevant components.

2. The Director of the Provincial Department of Health shall establish a Secretariat to assist the Director of the Provincial Department of Health in reviewing applications for issuing, reissuing professional practice certificates, consisting of the following components:

a) The Head of the Medical Practice Management Department or the Head of the Medical Affairs Department (for Provincial Departments of Health that have not established a Medical Practice Management Department) serving as the Head of the Secretariat;

b) A representative from the Medical Affairs Department (for Provincial Departments of Health that have established a Medical Practice Management Department);

c) A representative from the Personnel Department of the Provincial Department of Health;

d) Other relevant components.

3. The Secretariat's permanent office shall be located at the Directorate General of Medical Examination and Treatment - Ministry of Health or the Medical Practice Management Department or the Medical Affairs Department (for Provincial Departments of Health that have not established a Medical Practice Management Department) - Provincial Department of Health.

Article 10. Working Relationship between the Advisory Board and the Secretariat

1. The Secretariat shall be responsible for:

a) Seeking advisory opinions from the Advisory Board when necessary regarding matters related to issuing, reissuing, revoking professional practice certificates; suspending the professional activities of practitioners; recognizing certificates of continuous medical knowledge updates or other relevant documents concerning the recognition of individuals proficient in Vietnamese or other languages or having sufficient interpreting skills in medical examination and treatment;

b) Reporting to the Advisory Board a list of individuals who have been issued, reissued, or had their professional practice certificates revoked; cases where practitioners' professional activities have been suspended according to a six-monthly schedule.

2. The Advisory Board shall be responsible for:

a) Providing advisory opinions upon request from the Secretariat regarding matters stipulated in Point a, Clause 1 of this Article;

b) Notifying the Secretariat about cases where there is clear evidence indicating that the issuance, reissuance, revocation of professional practice certificates or suspension of professional activities of practitioners does not comply with the provisions of the law.

Section 3

REGISTRATION FOR PRACTICING MEDICAL EXAMINATION AND TREATMENT

Article 11. Principles of Registration for Practicing Medical Examination and Treatment

1. A practitioner may only register to be responsible for the technical and professional management of one medical examination and treatment facility, and may not simultaneously hold such responsibility in two or more medical examination and treatment facilities.

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

3. A practitioner responsible for the technical and professional management of a medical examination and treatment facility may concurrently serve as the head of a department within the same facility but may only be responsible for one department and must be consistent with the professional qualifications obtained through training.

4. A practitioner working at a state-owned medical examination and treatment facility may register to be responsible for the technical and professional management of another medical examination and treatment facility outside regular working 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 Law on Enterprises and the Law on Cooperatives, except in cases where they are appointed by competent state authorities to participate in management and operation at a medical examination and treatment facility with state capital.

6. A practitioner who has registered to be responsible for the technical and professional management of a medical examination and treatment facility may work outside regular hours at another medical examination and treatment facility in the same province, but the total time worked outside regular hours shall not exceed 200 hours as stipulated by the Labor Code.

7. A practitioner who has registered to work at a medical examination and treatment facility may not register to be responsible for the technical and professional management of a medical examination and treatment facility in another province to ensure continuity and stability in the provision of medical examination and treatment services.

8. A practitioner who has registered to work at a medical examination and treatment facility, when performing medical examination and treatment duties under a rotation system from higher-level facilities to lower-level ones, providing charitable medical examination and treatment, or implementing specialized techniques (such as consultations, surgical shifts) pursuant to contracts between medical examination and treatment facilities, does not need to register to work.

Article 12. Content and form of registration for practicing medical examination and treatment

1. Content of registration:

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: specify the working hours at the medical examination and treatment facility (from what time to what time on a daily basis and how many days in a week);

c) Professional position:

- Clearly state the department, room, or specialized unit where the practitioner works;

- Clearly state the title assigned to the practitioner (for example, head of the department, person responsible for technical expertise, head of the department, or staff member).

2. Form of registration: The registration for practice must be carried out in writing according to the model prescribed in Appendix 06 issued together with this Circular.

Article 13. Procedure for Registration for Practice

1. Time of registration for practice:

a) For medical examination and treatment facilities applying for an operating permit, the registration for practice of practitioners shall be conducted simultaneously with the application for the operating permit;

b) For medical examination and treatment facilities that have been granted an operating permit, when there is a change in personnel, within ten working days from the date of signing the employment decision or labor contract with the practitioner, or dismissing the practitioner, or terminating the labor contract with the practitioner, or the practitioner has notified of resignation, the medical examination and treatment facility shall be responsible for sending the list of newly accepted practitioners and the list of practitioners no longer working at their facility to the competent state management agency as stipulated in Clause 2 of this Article.

2. Acceptance of registration for practice documents:

a) The Provincial Department of Health accepts the registration for practice of medical examination and treatment facilities located within its jurisdiction (including private hospitals and medical examination and treatment facilities under various ministries and sectors), except for medical examination and treatment facilities directly under the Ministry of Health;

b) The Ministry of Health accepts the registration for practice of medical examination and treatment facilities directly under the Ministry of Health.

3. Confirmation of registration for practice:

a) For medical examination and treatment facilities applying for an operating permit, the confirmation of registration for practice must be reflected in the inspection report;

b) For medical examination and treatment facilities currently in operation, within ten working days from the date of receiving the list of registration for practice as stipulated in Clause 1 of this Article, based on the principles of registration for practice prescribed in Article 11 of this Circular, the Minister of Health or the Director of the Provincial Department of Health must issue a document approving the registration for practice. In cases where approval is not given, a document must be issued stating the reasons for rejection for each specific case.

4. If the list of registration for practice of a medical examination and treatment facility includes a practitioner who is already practicing at another medical examination and treatment facility, then in the list of registered practitioners, the time, place, and professional position of the practitioner at the previous medical examination and treatment facility must be clearly stated.

Article 14. Management of Information on Registration for Practice

1. Within ten working days after approving the registration for practice of a practitioner, the Provincial Department of Health must send the list of practitioners registered within its jurisdiction to the Ministry of Health.

2. Within ten working days after approving the registration for practice of a practitioner, the Ministry of Health must send the list of registered practitioners to the Provincial Department of Health where the medical examination and treatment facility with the registered practitioner is located.

Section 4

CONFIRMATION OF PRACTICE PROCESS

Article 15. Principles for Registration of Practical Training

The person applying for a professional practice certificate must register practical training consistent with their specialized degree obtained from education.

In the case of a general practitioner, they must register practical training in one of the four specialties: internal medicine, surgery, obstetrics, pediatrics, or in one of the systems: internal-pediatrics or surgery-obstetrics. If registering under a system, the total practical training period must be 18 months, with at least 9 consecutive months in each specialty within the system.

In the case of a general health worker, they must register practical training in one of the four specialties: internal medicine, surgery, obstetrics, pediatrics, or in one of the systems: internal-pediatrics or surgery-obstetrics. If registering under a system, the total practical training period must be 12 months, with at least 6 consecutive months in each specialty within the system.

Article 16. Confirmation of Practical Training Period

1. Confirmation of practical training period for doctors:

a) For doctors who have been practicing medical examination and treatment before January 1, 2012:

- If there has been at least 18 consecutive months of medical examination and treatment at healthcare facilities, confirmation will be given that they have completed the required practical training period;

- If there has not been at least 18 consecutive months of medical examination and treatment at healthcare facilities, the time spent on medical examination and treatment before January 1, 2012 will be counted as practical training time (determined from the date of signing the labor contract or employment decision) and they must continue practical training until they complete 18 months to be confirmed as having completed the required practical training period;

- If there has been at least 18 months of medical examination and treatment at healthcare facilities but did not continue such activities for a period of two years up to the date of submitting the application for a professional practice certificate, they do not need to undergo practical training again if they have a continuous medical knowledge update certificate. If they do not have a continuous medical knowledge update certificate, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law;

b) For doctors who started practicing medical examination and treatment from January 1, 2012, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law.

2. Confirmation of practical training period for health workers:

a) For health workers who have been practicing medical examination and treatment before January 1, 2012:

- If there has been at least 12 consecutive months of medical examination and treatment at healthcare facilities, confirmation will be given that they have completed the required practical training period;

- If there has not been at least 12 consecutive months of medical examination and treatment at healthcare facilities, the time spent on medical examination and treatment before January 1, 2012 will be counted as practical training time (determined from the date of signing the labor contract or employment decision) and they must continue practical training until they complete 12 months to be confirmed as having completed the required practical training period;

- If there has been at least 12 months of medical examination and treatment at healthcare facilities but did not continue such activities for a period of two years up to the date of submitting the application for a professional practice certificate, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law.

b) For health workers who started practicing medical examination and treatment from January 1, 2012, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law.

3. Confirmation of practical training period for midwives, technicians, and nursing assistants:

a) For midwives, technicians, and nursing assistants who have been practicing medical examination and treatment before January 1, 2012:

- If there has been at least 9 consecutive months of medical examination and treatment at healthcare facilities, confirmation will be given that they have completed the required practical training period;

- If there has not been at least 9 consecutive months of medical examination and treatment at healthcare facilities, the time spent on medical examination and treatment before January 1, 2012 will be counted as practical training time (determined from the date of signing the labor contract or employment decision) and they must continue practical training until they complete 9 months to be confirmed as having completed the required practical training period;

- If there has been at least 9 months of medical examination and treatment at healthcare facilities but did not continue such activities for a period of two years up to the date of submitting the application for a professional practice certificate, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law.

b) For midwives, technicians, and nursing assistants who started practicing medical examination and treatment from January 1, 2012, they must follow the regulations stipulated in Clause 1, Article 24 of the Medical Examination and Treatment Law.

4. The Minister of Health or the Director of the Provincial Department of Health shall be responsible for assigning healthcare facilities under their management to participate in guiding practical training for those seeking confirmation of their practical training period.

Article 17. Content of Confirmation Regarding Professional Competence and Professional Ethics

1. The content of confirmation regarding professional competence includes: The ability to perform basic technical skills according to the specialty registered for practice as prescribed by the head of the medical examination and treatment facility.

2. The content of confirmation regarding professional ethics includes: Compliance with obligations as stipulated in Articles 36, 37, 38, and 39 of the Medical Examination and Treatment Law and communication and conduct of the person registering for practice as prescribed in Decision No. 29/2008/QD-BYT dated August 18, 2008, issued by the Minister of Health on the Code of Conduct for Staff in Public Health Institutions.

Article 18. Organization of Practice

1. Acceptance of Practitioners:

a) The practitioner must submit a certified copy of their professional certificate and a request form as prescribed in Appendix 07 accompanying this Circular to the medical examination and treatment facility where they intend to participate in practice.

b) The head of the medical examination and treatment facility is responsible for issuing a decision to accept the practitioner and assigning a supervisor for practice as prescribed in Appendix 08 accompanying this Circular. In cases where the practitioner is not an employee of the medical examination and treatment facility, a contract must be agreed upon as prescribed in Appendix 09 accompanying this Circular.

2. The supervisor for practice must be a practicing individual whose scope of professional activities is appropriate to the specialty registered for practice by the practitioner.

3. The supervisor for practice is responsible for guiding the practitioner in conducting medical examinations and treatments. The supervisor for practice must bear responsibility for the results of the medical examinations and treatments conducted by the practitioner during the practice period.

4. After the completion of the practice period, the supervisor for practice must evaluate the practitioner's practice process as prescribed in Article 17 of this Circular and be responsible for the content of the evaluation.

5. Following the evaluation by the supervisor for practice as stipulated in Clause 3 of this Article, the head of the medical examination and treatment facility must issue a certificate confirming the practice process as prescribed in Appendix 10 accompanying this Circular.

Section 5

CRITERIA FOR RECOGNITION OF FLUENCY IN VIETNAMESE OR FLUENCY IN ANOTHER LANGUAGE OR ENOUGH LEVEL IN INTERPRETING IN MEDICAL EXAMINATION AND TREATMENT

或具备其他语言能力或翻译水平的医疗机构

Article 19. Criteria for Recognition of Fluency in Vietnamese or Fluency in Another Language in Medical Examination and Treatment

1. A practitioner is recognized as fluent in Vietnamese in medical examination and treatment when they are tested and confirmed to be proficient in all four skills of listening, speaking, reading, and writing in Vietnamese by the educational institution specified in Clause 1 of Article 21 of this Circular, except for the cases specified in Clause 3 of this Article.

2. A practitioner is recognized as fluent in another language other than Vietnamese that is not their native language in medical examination and treatment when they are tested and confirmed to be proficient in all four skills of listening, speaking, reading, and writing in the language they have registered to use in medical examination and treatment by the educational institution specified in Clause 1 of Article 21 of this Circular, except for the cases specified in Clause 3 of this Article.

3. Cases that can be recognized without testing if they possess any of the following certificates or diplomas:

a) Hold a diploma from a secondary vocational education program in medicine or higher, issued by a legitimate domestic or foreign training institution, where the entire curriculum was taught in Vietnamese or in the language the practitioner has registered to use in medical examination and treatment;

b) Hold a certificate of completion of a specialized medical training course lasting at least 12 months, where the language of instruction was Vietnamese or in the language the practitioner has registered to use in medical examination and treatment;

c) Hold a bachelor's degree in Vietnamese or in the language the practitioner has registered to use in medical examination and treatment, issued by legitimate domestic or foreign training institutions.

The certificates and diplomas specified in Clause 3 of this Article must have been issued within five years prior to the date of submission of the application.

Article 20. Criteria for Recognizing Individuals with Sufficient Interpretation Proficiency in Medical Examination and Treatment

1. An individual shall be recognized as having sufficient interpretation proficiency in medical examination and treatment when they are proficient in all four language skills (listening, speaking, reading, and writing) in a foreign language and have been tested and recognized as having sufficient interpretation proficiency in medical examination and treatment by the educational institution specified in Clause 1 of Article 21 of this Circular, except for the cases stipulated in Clause 2 of this Article.

2. The following cases shall be recognized without undergoing testing if one of the following certificates or diplomas is held:

a) Holding a diploma from a specialized secondary level or higher in medicine issued by a legitimate domestic or foreign training institution where the entire training program was conducted in a foreign language;

b) Holding a certificate of completion of specialized medical courses lasting 12 months or more, where the language of instruction was a foreign language;

c) Holding a diploma from a specialized secondary level or higher in medicine or a traditional doctor's degree and a bachelor’s degree in foreign languages.

The certificates or diplomas specified in Point a and b of Clause 2 of this Article must have been issued within no more than five years from the date of submission of the application.

Article 21. Conditions for Educational Institutions to Conduct Testing and Recognition of Proficiency in Vietnamese or Other Languages or Sufficient Interpretation Proficiency in Medical Examination and Treatment

1. An educational institution shall be eligible to conduct testing and recognition of proficiency in Vietnamese or other languages or sufficient interpretation proficiency in medical examination and treatment when it meets the following conditions:

a) It is a university specializing in medicine;

b) It has a department or subject of foreign languages;

c) It has a bank of tests for testing and recognizing proficiency in Vietnamese or other languages or sufficient interpretation proficiency in medical examination and treatment.

2. Documents and procedures:

a) Documents:

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

- A certified copy of the decision establishing the department or subject of foreign languages;

- A list of full-time lecturers working in the department or subject of foreign languages;

- A bank of tests used for testing and recognizing proficiency in Vietnamese or other languages or sufficient interpretation proficiency in medical examination and treatment in one of the following languages: English, French, Russian, Chinese, Arabic, Spanish, German, Japanese, and Korean.

b) Procedures:

- Based on the conditions specified in Clause 1 of this Article, the educational institution shall prepare the documents according to Point a of Clause 2 of this Article and submit them to the Ministry of Health (Department of Science and Training) to request recognition of eligibility. The content of the questions and answers in the test bank may be submitted on paper, CD, DVD, USB, or email;

- Within fifteen working days from the date of receiving valid applications, the Ministry of Health must issue a written permit. In case of rejection, the reasons must be clearly stated. If necessary, the Ministry of Health will conduct an actual inspection at the requesting institution before granting permission.

Article 22. Documents and Procedures for Requesting Testing or Recognition of Proficiency in Vietnamese or Other Languages or Sufficient Interpretation Proficiency in Medical Examination and Treatment

1. Application documents for testing include:

a) A request form according to the model prescribed in Appendix 11 attached to this Circular and two photographs measuring 4x6 cm taken against a white background within six months from the date of submission;

b) A certified copy of the identity card or passport still valid.

a) A request form for recognizing equivalent certificates or diplomas according to Form No. 08/PLI as prescribed in Appendix I issued together with this Circular.

a) The documents specified in Points a and b of Clause 1 of this Article;

b) A certified copy of the certificates or diplomas specified in Clause 3 of Article 19 of this Circular for foreigners or overseas Vietnamese requesting recognition of proficiency in Vietnamese, or Clause 2 of Article 20 of this Circular for individuals requesting recognition of sufficient interpretation proficiency in medical examination and treatment, or Point d of Clause 1 of Article 6 of this Circular for individuals practicing using another language in medical examination and treatment.

3. Procedures for requesting testing or recognition:

a) The documents specified in Clause 1 or Clause 2 of this Article shall be sent to the educational institution specified in Clause 1 of Article 21 of this Circular;

b) Within thirty days from the date of receipt of complete documents, the educational institution must perform the following:

- Test and issue a certificate for the cases stipulated in Clause 1, Clause 2 of Article 19, Clause 1 of Article 20. The test results must be publicly announced;

- Or issue a certificate for the cases stipulated in Clause 3 of Article 19, Clause 2 of Article 20. In case of not issuing a certificate, a written response must be provided with clear reasons.

4. The certificate shall be issued according to the model prescribed in Appendix 12 attached to this Circular.

Chapter III

PROVISIONS ON THE CONDITIONS FOR OPERATING HEALTH CARE FACILITIES AND MEDICAL INSTITUTIONS

Section 1

SPECIFIC REQUIREMENTS FOR GRANTING LICENSE TO OPERATE DIFFERENT FORMS OF ORGANIZATIONS OF HEALTH CARE FACILITIES AND MEDICAL INSTITUTIONS

医疗机构中的医务人员在诊疗过程中

Article 23. Conditions for Granting License to Operate Hospitals

1. Scale of hospitals:

a) General hospitals must have at least 30 beds or more;

b) Specialized hospitals and traditional medicine hospitals must have at least 20 beds; specifically, specialized eye hospitals using advanced technology must have at least 10 beds.

Clause 2. Infrastructure:

a) Must be designed and constructed according to Vietnam Construction Standard No. 365:2007. Specifically, for emergency departments, intensive care units, detoxification units, surgery departments, diagnostic imaging departments, and laboratory departments, the design and construction must comply with the provisions set out in Decisions No. 32, 33, 34/2005/QD-BYT dated October 31, 2005 and No. 35/2005/QD-BYT dated November 15, 2005 issued by the Minister of Health;

In cases where hospitals are built on land within districts of centrally governed cities and do not meet the land area requirements stipulated in Vietnam Construction Standard No. 365:2007, they may be designed and constructed in multi-story buildings but must satisfy the following conditions:

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

- Ensuring a minimum floor area of 50 square meters per bed; the width of the front facade (front face) of the hospital must be at least 10 meters. For hospitals that were operating before January 1, 2012, they are allowed to continue operations but must meet the condition regarding the width of the front facade of the hospital by January 1, 2016 at the latest.

b) Ensuring conditions for radiation safety, medical waste management, and fire prevention and control as prescribed by law;

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

3. Medical Equipment:

a) Having adequate medical equipment and instruments suitable for the scope of professional activities registered by the hospital;

b) Having sufficient emergency transport facilities both inside and outside the hospital. In cases where there are no emergency transport facilities outside the hospital, the hospital must have a contract with a facility providing such services.

4. Organization:

a) Departments:

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

- Outpatient department (including reception area, emergency room, consultation rooms, minor surgery rooms);

- Ancillary clinical departments: Having at least two laboratories and diagnostic imaging units. Specifically, for specialized eye hospitals without a diagnostic imaging unit, they must have a contract with a healthcare facility with a diagnostic imaging unit that has been granted a license to operate;

- Pharmacy department;

- Other specialized departments in the hospital must be commensurate with the scale and functions of the hospital.

b) Having functional offices for planning and integration, human resources, nursing, finance and accounting.

5. Personnel:

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

b) Staff quota, proportion of specialized units shall be implemented in accordance with the provisions of Clause 1, 2, 3, and 4 Section II Circular Joint No. 08/2007/TTLT-BYT-BNV dated June 5, 2007 issued by the Ministry of Health and the Ministry of Home Affairs guiding the staffing quota for public health institutions;

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

- Being a doctor with a practice certificate corresponding to at least one of the specialties registered for operation by the hospital;

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

- Working full-time at the hospital.

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

- Being a doctor with a practice certificate corresponding to the specialty;

- Having at least 36 months of experience in diagnosis and treatment in that specialty. The assignment and appointment of the head of the department must be documented in writing;

- Working full-time at the hospital;

đ) The heads of other departments must meet the following conditions:

Graduating from university and having at least 36 months of work experience in that specialty from the date of receiving the bachelor's degree to the date of being assigned and appointed as head of the department. The assignment and appointment of the head of the department must be documented in writing;

- Working full-time at the hospital;

e) The head of the pharmacy department must work full-time at the hospital and must meet the provisions of Clause 1 Article 7 Circular No. 22/2011/TT-BYT dated June 10, 2011 issued by the Minister of Health on the organization and operation of the hospital pharmacy department;

g) Surgeons must meet the following conditions:

- Being a specialist surgeon or a general practitioner with a training certificate in surgery from provincial-level general hospitals or universities specializing in medicine or at Training and Guidance Centers under special-class and class-1 hospitals directly under the Ministry of Health. In cases of training abroad, surgeons must have a specialist certificate;

- Having a written authorization to perform surgery and surgical interventions from the head of the hospital based on the recommendation of the person responsible for technical expertise in the hospital;

h) In addition to the subjects specified in Points c, d, đ, e, and g of this Clause, other subjects working in the hospital who engage in diagnosis and treatment must have a practice certificate and can only perform diagnosis and treatment within the scope of their assigned tasks. The assignment must be documented in writing and must be consistent with the scope of professional activities recorded in their practice certificate.

6. Scope of Professional Activities:

Implementing professional techniques according to the list approved by the Minister of Health or the Director of the Provincial Department of Health.

Article 24. Conditions for Issuing a Business License for a Multispecialty Clinic

1. Scale of a Multispecialty Clinic:

A multispecialty clinic must meet at least the following conditions:

a) Have at least two out of four specialties: internal medicine, surgery, obstetrics, and pediatrics;

b) Emergency room;

c) Minor operation room;

d) Patient observation room;

đ) Diagnostic services: Must have two departments: laboratory and imaging;

Clause 2. Infrastructure:

a) There must be a reception area, emergency room, patient observation room, specialty consultation rooms, and minor operation room. The rooms within the multispecialty clinic must meet the minimum requirements regarding area as follows:

- The emergency room must have an area of at least 12 square meters;

- The patient observation room must have an area of at least 15 square meters; it must have at least two observation beds, and if there are three or more observation beds, each bed must have an area of at least 5 square meters;

- Specialty consultation rooms and minor operation rooms must have an area of at least 10 square meters. Specifically, for state-owned regional multispecialty clinics, design standards must comply with Decision No. 1327/2002/QĐ-BYT dated April 18, 2002, issued by the Minister of Health;

b) Ensuring conditions for radiation safety, medical waste management, and fire prevention and control as prescribed by law;

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

3. Medical Equipment:

Must have sufficient medical equipment and instruments appropriate to the scope of professional activities registered by the multispecialty clinic.

4. Human Resources Organization:

a) The number of full-time doctors (permanent staff) must reach at least 50% of the total number of doctors in the multispecialty clinic;

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

- Be a doctor with a practice certificate suitable for at least one of the specialties registered by the multispecialty clinic;

- Have at least 54 months of experience in diagnosing and treating patients. The assignment and appointment of the person responsible for technical and professional management of the multispecialty clinic must be documented in writing;

- Be a full-time employee at the multispecialty clinic;

c) In addition to the person responsible for technical and professional management of the multispecialty clinic, other individuals working in the multispecialty clinic who perform diagnosis and treatment must have a practice certificate and can only perform such activities within the scope of work assigned to them. The assignment must be consistent with the scope of professional activities recorded on their practice certificate.

5. Scope of Professional Activities:

Practice according to the scope of professional activities approved by the Director of the Provincial Department of Health. Approval must be based on the provisions regarding the scope of professional activities set forth in Articles 25, 26, 28, 29, 30, 32, 33, and 34 of this Circular.

Article 25. Conditions for Issuing a Business License for a Specialty Clinic

1. Infrastructure:

a) Construction and Design:

- A fixed location separate from family living areas;

- Constructed solidly, well-lit, with dust-proof ceilings, walls and floors must use materials that are easy to clean and sanitize;

b) A specialty clinic must have a consultation and treatment room with an area of at least 10 square meters and a reception area for patients, except for telephone consultation rooms, health counseling rooms through information technology and telecommunications means, and medical equipment. For surgical specialty clinics and plastic surgery specialty clinics, there must also be a patient observation room with an area of at least 12 square meters; rehabilitation specialty clinics must also have a rehabilitation room with an area of at least 10 square meters;

c) In addition to the provisions in Point b Clause 1 of this Article, depending on the scope of professional activities registered, the clinic must also meet the following additional conditions:

- Have a procedure room with an area of at least 10 square meters if procedures are performed, including dental implant techniques;

- Have a functional examination room with an area of at least 10 square meters if functional examinations are performed;

- Have a gynecological examination room with an area of at least 10 square meters if gynecological examinations or sexually transmitted disease examinations are performed;

- Have a family planning technique room with an area of at least 10 square meters if family planning techniques are performed;

- Have a physical therapy room with an area of at least 40 square meters if physical therapy is performed;

- If a dental specialty clinic has three or more dental chairs, the area for each chair must be at least 5 square meters;

- If a specialty clinic uses radiation equipment (including dental X-ray machines attached to dental chairs), it must comply with legal regulations on radiation safety;

d) Ensure the disposal of medical waste in accordance with legal regulations; ensure sterilization for the procedure room, implant insertion room, and family planning room;

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

2. Medical Equipment:

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

b) Must have a box of anti-shock drugs and sufficient emergency medications for specialized care;

c) Telephone consultation rooms, health counseling rooms through information technology and telecommunications means, and medical equipment do not need to have the medical equipment and instruments specified in Points a and b Clause 2 of this Article but must have sufficient information technology and telecommunications equipment and medical devices appropriate to the registered advisory activities.

3. Personnel:

a) The person responsible for technical and professional management of a specialty clinic must be a doctor with a practice certificate suitable for the specialty registered by the clinic and have at least 54 months of experience in diagnosing and treating patients in that specialty;

b) In addition to the person responsible for technical and professional management of the specialty clinic, other individuals working in the specialty clinic who perform diagnosis and treatment must have a practice certificate and can only perform such activities within the scope of work assigned to them. The assignment must be consistent with the scope of professional activities recorded on their practice certificate;

4. Scope of Technical Activities:

a) Internal Medicine General Clinics, Family Doctor Clinics:

- Provide first aid, diagnose, and treat common internal diseases, without performing specialized procedures;

- Perform electrocardiogram, electroencephalogram, electromyography, cerebral angiography, ultrasound, and gastroscopy techniques if the doctor directly performing these techniques has a certificate of specialized training from a provincial-level hospital or higher. In cases where gastroscopy techniques are performed, an additional confirmation of having practiced in the specialty for at least 18 months at a healthcare facility is required.

Specifically, Family Doctor Clinics may provide health care and diagnose and treat patients at their homes.

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

b) Specialized clinics under the internal system (cardiovascular, respiratory, digestive, pediatric, and other internal specialties):

- Emergency care, diagnosis, and treatment for internal specialty diseases.

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

c) Clinics providing consultation for diagnosis and treatment via telephone and health care consultation through information and communication technology means and medical equipment:

- The consultation room can only provide advice within the scope of specialties that have been approved.

- Practitioners can only provide health care advice appropriate to their issued practice certificates.

d) Specialized surgical clinics:

- Initial emergency care for surgical cases;

- Examination and treatment of common wounds;

- Plastering and removing plaster from small bone fractures;

- Excising sebaceous cysts and small benign tumors;

- Not draining large spreading abscesses.

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

đ) Specialized obstetric-gynecological family planning clinics:

- Initial emergency care for obstetric and gynecological cases;

- Prenatal examination and management of pregnancy;

- Diagnosis and treatment of common gynecological diseases;

- Insertion of vaginal medication;

- Laser treatment for cervical ectopy;

- Cervical colposcopy and biopsy for cancer cells;

- Obstetric ultrasound if the doctor directly performs ultrasound techniques with a certificate of specialized training from a provincial-level hospital or higher and has undergone at least 18 months of practical training in obstetrics at a healthcare facility;

- Insertion of intrauterine devices;

- Medical abortion for pregnancies up to 06 weeks (from 36 to 42 days, counted from the first day of the last menstrual period) when meeting the conditions specified in the national standards for reproductive health services issued by the Minister of Health;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

e) Specialized oral and maxillofacial clinics:

- Routine diagnosis and treatment, initial emergency care for oral and maxillofacial injuries;

- Performing minor surgeries to repair small scars less than 02 cm long on the face;

- Correcting jaw misalignment;

- Surface laser therapy;

- Treating periodontal diseases;

- Incising and draining abscesses, scaling teeth, and tooth extraction;

- Denture and partial denture fabrication;

- Orthodontic treatment;

- Root canal treatment;

- Simple dental implant placement involving one to two teeth in a single procedure (with a maximum of four front lower teeth), provided the doctor performing the technique holds a certificate or confirmation of dental implant training from a medical university or a provincial-level hospital or higher. Bone grafting using autologous tissue for implants is not allowed, nor is it permitted for patients with ongoing internal medical conditions affecting the quality of the implant;

- Minor oral surgery procedures;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

g) Specialized otolaryngology clinics:

- Routine diagnosis and treatment, initial emergency care for ear, nose, and throat conditions;

- Sinusitis, sinus puncture, and drainage of cysts;

- Incision and drainage of acute middle ear infections;

- Incision and drainage of peritonsillar abscesses;

- Simple removal of nasal polyps, sebaceous cysts, and benign tumors in the ear, nose, and throat area;

- Stopping nosebleeds;

- Removal of foreign bodies from the ear, nose, and throat, excluding those in the larynx and esophagus;

- Thermal and laser throat ablation;

- Adenoidectomy;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

h) Specialized ophthalmology clinics:

- Routine diagnosis and treatment, initial emergency care for eye conditions;

- Subconjunctival and periocular injections;

- Removal of foreign bodies from the conjunctiva and cornea, and chalazion incision and drainage;

- Lacrimal duct irrigation;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

i) Aesthetic surgery clinics:

- Creating dimples, tattoo removal, eyebrow lifting, cheek shaping, cleft chin, pointed chin, facial skin correction, neck skin correction;

- Eyelid, nose, lip, and ear shaping;

- Prohibited from performing aesthetic surgeries such as breast augmentation; breast lift; reduction of the areola and nipple; abdominoplasty, buttock, and thigh reduction; facelift, buttock, and thigh lift; body fat extraction;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic;

- Aesthetic surgeries that alter identifiable features listed on identification cards can only be performed after the person requesting the surgery submits a letter to the police station issuing the identification card.

k) Rehabilitation clinics:

- Rehabilitation for central and peripheral nervous system paralysis syndromes and chronic diseases or post-surgical conditions;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

l) Mental health clinics:

- Emergency care, outpatient diagnosis, and treatment of mental disorders and epilepsy;

- Implementation of psychological therapy methods;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

m) Oncology clinics:

- Early detection of common cancers;

- Biopsy for cytology and histopathology tests of certain types of cervical, rectal, vulvar, breast, and lymph node cancers. These cytology and histopathology test results must be concluded by a specialist in pathology-cytology;

- Regular follow-up examinations for cancers that have been or are currently being treated;

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

n) Dermatology clinics:

- Diagnosis and treatment of skin diseases, leprosy, and sexually transmitted diseases.

- Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capacity of the practitioner and the medical equipment and infrastructure conditions of the clinic.

Article 26. Conditions for Issuing a Permit to Operate a Traditional Medicine Treatment Room

1. Infrastructure:

a) Meeting the conditions stipulated in Points a, d, and đ Clause 1 Article 25 of this Circular;

b) The treatment room must have an area of at least 10 square meters and a reception area for patients;

c) Depending on the scope of registered specialized activities, the traditional medicine treatment room must also meet the following additional conditions:

- If acupuncture and massage are performed, there must be a room or designated area for acupuncture and massage with an area of at least 05 square meters per bed;

- If herbal steam therapy is performed, there must be a steam room. The minimum area is 02 square meters for one steam room, which must be enclosed but well-lit;

- If pre-packaged herbal preparations are produced, they must be reviewed and approved by the Provincial Health Department;

2. Medical Equipment:

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

- There must be a medicine cabinet, with herbs stored in drawers or bottles with lids clearly labeled with the name of the herb outside;

- There must be a scale for measuring herbs and dividing them according to prescriptions;

b) If performing acupuncture, massage, and acupressure:

- There must be beds for acupuncture, massage, and acupressure;

- There must be sufficient equipment for acupuncture, massage, and acupressure, infrared lamps;

- There must be sufficient equipment and instructions for handling post-acupuncture care;

c) If performing herbal steam therapy: there must be a system for generating herbal steam;

3. Personnel:

a) The person responsible for technical and professional management of the traditional medicine treatment room must be a specialist doctor in traditional medicine, a specialist assistant doctor in traditional medicine, or a person holding a certificate of a traditional medicine practitioner issued by the Ministry of Health or the Provincial Health Department, or a person with a family prescription or a family healing method, who holds a practice certificate for traditional medicine diagnosis and treatment;

- For specialist doctors in traditional medicine, there must be at least 54 months of experience in diagnosing and treating with traditional medicine;

- For specialist assistant doctors in traditional medicine, there must be at least 48 months of experience in diagnosing and treating with traditional medicine;

- For traditional medicine practitioners or persons with family prescriptions or family healing methods, there must be at least 36 months of experience in diagnosing and treating with traditional medicine;

b) In addition to the person responsible for technical and professional management of the traditional medicine treatment room, other individuals working in the treatment room who perform medical examinations and treatments must hold a practice certificate and can only conduct such activities within the scope of work assigned to them, which must correspond to the scope of specialized activities specified in their practice certificate;

4. Scope of Technical Activities:

a) Diagnosing and treating with traditional medicine (using and not using medicines);

b) Using finished traditional medicine products manufactured by other facilities that have been registered for circulation by the Ministry of Health to serve medical examinations and treatments;

c) Compounding raw herbs into cooked medicines (powders), weighing prescriptions for patients;

d) Practitioners using family prescriptions or family healing methods may only diagnose and treat using those specific family prescriptions or methods;

đ) In cases where certain pre-packaged forms (such as decoctions, pills, powders, or other forms) are produced directly for patients in the treatment room, registration with the Provincial Health Department regarding the formula of the prescription, production process (accompanied by a statement explaining the physical facilities and equipment), efficacy, dosage, contraindications, and drug label samples is required. The Provincial Health Department will review and approve the conditions before production can commence. The medicines are solely for direct use by patients in the treatment room and shall not be circulated on the market in accordance with the provisions of the Drug Law.

Article 27. Conditions for Issuing a Permit to Operate a Medical Forensic Facility

A medical forensic facility that conducts medical examinations and treatments must operate under one of the organizational forms specified in Articles 24 and 25 of this Circular.

Article 28. Conditions for Issuing a Permit to Operate a Maternal and Child Health Care Home

1. Infrastructure:

a) Construction and Design:

- The building must be solid, equipped with specialized rooms, sufficient lighting, ceiling dust-proof, walls and floors must use materials that are easy to clean;

- The rooms must be designed in a continuous and rational manner to facilitate emergency care, medical examination, and treatment.

b) The maternal and child health care home must have antenatal examination rooms, gynecological examination rooms, family planning technique rooms, each room having a minimum area of 10 square meters; delivery rooms having a minimum area of 16 square meters; postpartum rest rooms having a minimum area of 20 square meters to ensure a minimum space of 5 square meters per bed.

c) The rooms specified in Points a and b of Clause 1 of this Article must meet the requirements for construction and completion of works as stipulated in Point 5.4 of Clause 5 on completion and construction requirements of Decision No. 2271/2002/QĐ-BYT dated June 17, 2002 of the Minister of Health on issuing the Design Standards for Basic Health Stations - Industry Standard.

d) Ensure the disposal of medical waste and conditions for radiation safety (if applicable) in accordance with the provisions of the law.

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

2. Medical Equipment:

a) Must have adequate medical equipment and supplies suitable for the scope of professional activities registered by the maternal and child health care home.

b) Must have emergency transport facilities both inside and outside the maternal and child health care home. In cases where there are no emergency transport facilities outside the home, a contract must be made with a facility that has such facilities.

3. Organization and Personnel:

a) Must have an organizational structure appropriate to the scope of professional activities registered in the application for operating permit.

b) The person responsible for technical expertise at the maternal and child health care home must meet the following conditions:

- Be a doctor or bachelor of midwifery (university graduate) with a practice certificate;

- Have at least 54 months of experience in examining and treating obstetric and gynecological diseases for doctors or at least 45 months for bachelor of midwifery (university graduate);

- Be a full-time employee at the maternal and child health care home.

c) Apart from the person responsible for technical expertise at the maternal and child health care home, other individuals working in the home who conduct medical examinations and treatments must have a practice certificate and can only perform these tasks within the scope of their assigned duties. The assignment must be consistent with the scope of professional activities recorded in their practice certificate.

4. Scope of Technical Activities:

a) Antenatal examination, pregnancy management;

b) Initial emergency care, obstetric first aid;

c) Tetanus vaccination;

d) Urine protein test;

đ) Delivery assistance;

e) Post-delivery retained placenta removal; post-abortion retained placenta removal;

g) Insertion of intrauterine contraceptive devices;

h) Aspiration abortion, medical abortion for pregnancies ≤ 06 weeks (from 36 to 42 days, counted from the first day of the last menstrual period) when meeting the conditions stipulated in the national standards for reproductive health services issued by the Minister of Health;

i) Other specialized techniques approved by the Director of the Provincial Department of Health based on the actual capabilities of the practitioner and the medical equipment and infrastructure of the clinic.

Article 29. Conditions for Issuing a Permit to Operate an Imaging Diagnostic Clinic

1. Infrastructure:

a) Construction and Design:

- A fixed location separate from family living areas;

- Constructed solidly, well-lit, with dust-proof ceilings, walls and floors must use materials that are easy to clean and sanitize;

- The X-ray room, CT scanner room, and MRI room must comply with the radiation safety regulations stipulated by law;

- The ultrasound room and diagnostic endoscopy room must be designed independently, each room having a minimum area of 10 square meters; specifically, for digestive endoscopy, if both upper and lower gastrointestinal endoscopy techniques are performed, there must be two separate rooms;

b) Ensuring the handling of medical waste and compliance with radiation safety conditions as prescribed by law;

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

2. Medical Equipment:

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

b) Having personal protective equipment in accordance with the radiation safety regulations stipulated by law;

3. Personnel:

a) The person responsible for technical expertise at the imaging diagnostic clinic must be a physician holding a practice certificate and having at least 54 months of direct experience in diagnosing and treating diseases through imaging diagnostics;

b) In addition to the person responsible for technical expertise at the imaging diagnostic clinic, other individuals working in the imaging diagnostic clinic who perform specialized imaging diagnostic techniques must hold a practice certificate and may only conduct diagnosis and treatment within the scope of their assigned tasks. The assignment must align with the professional activities specified on their practice certificate;

4. Scope of Technical Activities:

a) Radiography, computed tomography, magnetic resonance imaging;

b) Doppler ultrasound, conventional ultrasound, diagnostic endoscopy;

c) Not using intravenous contrast media in the imaging diagnostic clinic;

d) Not performing guided biopsies under ultrasound guidance, not conducting laparoscopic surgery, not bronchoscopies, and not performing interventional radiology procedures involving bleeding;

đ) A Bachelor's degree holder in Radiography (graduated from university) is not allowed to make diagnostic conclusions;

e) Other specialized techniques approved by the Director of the Provincial Health Department based on the actual capability of the practitioner and the medical equipment and infrastructure conditions of the clinic;

Article 30. Conditions for Issuing a Permit to Operate a Laboratory

1. Infrastructure:

a) Construction and Design:

- A fixed location separate from family living areas;

- The laboratory must meet the architectural design and technical solution requirements as stipulated in Sections 6 and 7 of Decision No. 35/2005/QD-BYT dated October 31, 2005, issued by the Minister of Health regarding the Design Standards for Hospital Laboratory Departments - Industry Standards;

b) For laboratories that perform microbiological tests posing a risk of infectious disease transmission to humans, in addition to meeting the conditions set out in Points a of Clause 1 of this Article, they must also comply with the provisions of Decree No. 92/2010/NĐ-CP dated August 30, 2010, of the Government concerning biosafety in laboratories;

c) Ensuring the handling of medical waste in accordance with the law;

d) Ensuring sufficient electricity, water, and other conditions necessary to serve patient care;

2. Medical Equipment:

Having sufficient testing equipment and medical supplies to perform at least one of the six types of microbiological, biochemical, hematological, immunological, histopathological, and medical genetic tests;

3. Personnel:

a) The person responsible for technical expertise at the laboratory must meet the following conditions:

- Being a physician, biology bachelor's degree holder, chemistry bachelor's degree holder, university-level pharmacist, or laboratory technician (university graduate) holding a practice certificate;

- Having at least 54 months of experience in laboratory work, including postgraduate training in laboratory specialization, from the date of starting laboratory work (determined from the signing of the labor contract or employment decision) until the date of being appointed as the person responsible for technical expertise at the laboratory;

b) In addition to the person responsible for technical expertise at the laboratory, other individuals working in the laboratory who perform diagnosis and treatment must hold a practice certificate and may only conduct diagnosis and treatment within the scope of their assigned tasks. The assignment must align with the professional activities specified on their practice certificate;

4. Scope of Technical Activities:

Only performing tests that are compatible with the existing laboratory equipment and the actual capability of the practitioners at the laboratory.

Article 31. Conditions for Issuing a Business Operation Permit for Medical Service Facilities Providing Injection (Intravenous Infusion), Bandage Change, Pulse Counting, Temperature Measurement, and Blood Pressure Measurement Services

1. Infrastructure:

a) A fixed location with solid construction, adequate lighting, and separated from family living areas;

b) The injection (intravenous infusion) and bandage change room must have an area of at least 10 square meters;

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

2. Medical Equipment:

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

b) Must have an anti-shock medicine box.

3. Personnel:

a) The person responsible for technical and professional management of the medical service facility providing injection (intravenous infusion), bandage change, pulse counting, temperature measurement, and blood pressure measurement services must meet the following conditions:

- Must be a graduate of a medical college or higher with a practice certificate;

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

b) In addition to the person responsible for technical and professional management specified in Point a Clause of this Article, other individuals working in the facility who perform diagnosis and treatment 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 professional scope of activity recorded on their practice certificate.

4. Scope of Technical Activities:

a) Carry out injections (intravenous infusions) and bandage changes according to a doctor's prescription;

b) Perform pulse counting, temperature measurement, and blood pressure measurement;

c) Do not administer intravenous fluids; do not diagnose or treat illnesses and prescribe medications.

Article 32. Conditions for Issuing a Business Operation Permit for Dental Prosthetic Service Facilities

1. Infrastructure:

a) The examination room and prosthetic fitting room must have an area of at least 10 square meters;

b) The dental prosthetic fabrication room must have an area of at least 10 square meters or must contract with another dental prosthetic service facility;

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

2. Medical Equipment:

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

3. Personnel:

The person responsible for dental prosthetics must be a dental technician who has been practicing since before 1980 and was at least 18 years old at that time, and must have a confirmation letter from the People's Committee of the commune.

4. Scope of Technical Activities:

a) Provide dental prosthetics, jaw prosthetics, installation, and fixation;

b) Specifically, for dental technicians in Ho Chi Minh City who were permitted to practice since before 1980 and received training and skill assessment organized by the Health Department of Ho Chi Minh City in 1985 and 1986 and obtained a "Skill Assessment Certificate" meeting the requirements, if they wish to expand their professional scope to include filling cavities up to degree 2 and extracting single-rooted teeth with mobility, they must supplement their professional qualifications and ensure adequate medical equipment and an anti-shock medicine box as required for this type of service.

Article 33. Conditions for Issuing a Business Operation Permit for Home Healthcare Service Facilities

1. Medical Equipment:

Must have appropriate medical equipment and tools corresponding to the scope of professional activities registered by the home healthcare service facility.

2. Personnel:

a) The person responsible for technical and professional management of the home healthcare service facility must be a graduate of a medical college or higher with a practice certificate and must have at least 45 months of experience in diagnosing and treating illnesses;

b) In addition to the person responsible for technical and professional management of the home healthcare service facility, other individuals working in the home healthcare service facility who perform diagnosis and treatment 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 professional scope of activity recorded on their practice certificate.

3. Scope of Professional Activities:

a) Provide home healthcare services according to a doctor's prescription;

b) Do not administer intravenous fluids; do not diagnose or treat illnesses and prescribe medications.

Article 34. Conditions for Issuing an Operating Permit for Optical Service Facilities

1. Infrastructure:

a) A fixed location with solid construction, adequate lighting, and separated from family living areas;

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

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

2. Medical Equipment:

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

3. Personnel:

a) The person responsible for technical and professional management of the optical service facility must be a graduate of a medical vocational college or higher with a practice certificate in optical services and must have at least 45 months of experience in measuring, diagnosing refractive eye disorders at an optical service facility or an ophthalmology department of a hospital;

b) Practitioners of optical services must hold a practice certificate or a certificate in medical equipment (equipment for measuring and diagnosing refractive eye disorders) issued by a training institution designated by the Ministry of Health.

4. Scope of Technical Activities:

a) Measuring refractive eye disorders, advising on the use of glasses;

b) Grinding and fitting prescription glasses according to a doctor's prescription and providing warranty for prescription glasses.

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

1. Medical transportation equipment and means:

a) Must have sufficient transportation means, medical equipment, tools, anti-shock medicine boxes, and sufficient emergency medicines to ensure safety for patients;

b) Must have sufficient transportation means to ensure environmental hygiene when transporting patients.

2. Personnel:

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

- Be a physician holding a practice certificate;

- Have a certificate confirming completion of training in emergency resuscitation specialty;

- Must have at least 54 months of experience in medical examination and treatment.

b) In addition to the person responsible for technical and professional management specified in Point a of this Clause, other individuals working in domestic and international patient transport emergency services facilities who perform medical examinations and treatments must hold 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 in their practice certificate.

3. Must have a contract with an air service company if the facility registers for transporting patients abroad.

4. Scope of Technical Activities:

Providing emergency care and transporting patients domestically and internationally.

Article 36. Conditions for Issuing an Operating Permit for Village Clinics and Commune Health Stations

1. Infrastructure:

a) Must comply with the design standards set forth in Decision No. 2271/2002/QĐ-BYT dated June 17, 2002, issued by the Minister of Health regarding the Design Standards for Basic Health Stations - Industry Standards.

b) Must comply with legal regulations concerning medical waste management and fire prevention and control;

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

2. Medical Equipment:

Must have sufficient medical equipment and tools appropriate to the scope of specialized activities approved by the Director of the Provincial Department of Health.

3. Organization and Personnel:

The number of practitioners at commune health stations must meet the conditions stipulated in Section IV of Circular Joint Circular No. 08/2007/TTLT-BYT-BNV dated June 5, 2007, issued by the Ministry of Health and the Ministry of Home Affairs guiding staffing levels in state-owned healthcare institutions.

4. Scope of Technical Activities:

a) Village clinics and commune health stations must implement medical techniques according to the list of techniques in medical examinations and treatments promulgated by the Minister of Health and approved by the Director of the Provincial Department of Health;

b) Rural health workers must provide primary healthcare according to the assignments and professional guidance from the Head of the Commune Health Station.

Article 37. Medical facilities of agencies, units, organizations

1. Agencies, units, organizations that conduct medical examination and treatment shall implement according to one of the organizational forms prescribed in Articles 24, 25, and 36 of this Circular.

2. For medical facilities conducting medical examination and treatment in accordance with laws on drug prevention and control, prostitution prevention, and HIV/AIDS prevention:

a) If they were operating before January 1, 2012, in addition to meeting the conditions stipulated by specialized laws, they must also meet the conditions prescribed in Article 25 of this Circular no later than January 1, 2016;

b) If established after January 1, 2012, they must meet the conditions prescribed in Article 25 of this Circular to be granted a permit to operate.

Section 2

AUTHORITY, FILES, PROCEDURES FOR ISSUING, REISSUING, AND AMENDING OPERATING PERMITS

FOR MEDICAL FACILITIES

Article 38. Authority for issuing, reissuing, and amending operating permits for medical facilities.

1. The Minister of Health and the Director of the Provincial Department of Health shall issue, reissue, and amend operating permits for medical facilities in accordance with Clause 1 and Clause 2 of Article 45 of the Law on Medical Examination and Treatment.

2. The Minister of Health may delegate the Director of the Provincial Department of Health to approve certain contents related to the operation of private hospitals and hospitals under other ministries and sectors which have been granted operating permits by the Minister of Health, and must report in writing to the Ministry of Health immediately after approval, specifically as follows:

a) Review and approve in writing changes in bed capacity, organizational structure (establishment or dissolution of departments and divisions), and supplementary technical procedures as prescribed;

b) Approve in writing changes in hospital directors, technical professionals, department heads, and other practitioners.

Article 39. Files for requesting issuance, reissuance, and amendment of operating permits for medical facilities.

1. Files for requesting an operating permit for medical facilities as prescribed in Clause 1 of Article 46 of the Law on Medical Examination and Treatment, specifically as follows:

a) A request form for an operating permit according to the model prescribed in Appendix 13 issued together with this Circular;

b) A certified copy of the establishment decision for state-owned medical facilities or business registration certificate for private medical facilities or investment certificate for foreign-invested medical facilities;

c) Certified copies of practice certificates of all practitioners and a list of registered practitioners at the medical facility according to the model prescribed in Appendix 6 issued together with this Circular;

d) An inventory of physical infrastructure and medical equipment of the medical facility according to the model prescribed in Appendix 14 issued together with this Circular;

đ) Personnel files of medical staff working at the facility but not required to hold a practice certificate;

e) Documentation proving that the medical facility meets the conditions regarding physical infrastructure, medical equipment, and appropriate human resources organization in line with the scope of professional activities of one of the organizational forms prescribed in Section 1 Chapter III of this Circular;

g) Bylaws on organization and operation for state-owned hospitals implemented according to Decision No. 5571/QĐ-BYT dated December 29, 2006 of the Minister of Health on the model of bylaws on organization and operation of hospitals under the Ministry of Health; for private hospitals, implemented according to the model prescribed in Appendix 15 issued together with this Circular and initial operational plans for hospitals;

h) A certified copy of the contract with an air service company for patient transportation for emergency services and patient transport abroad;

i) A certified copy of the patient transportation contract for hospitals without their own emergency transportation means;

k) Proposed scope of professional activities: The medical facility proposes its scope of professional activities and technical procedure catalog based on the technical procedure catalog issued by the Minister of Health;

2. Files for requesting an operating permit for medical facilities when changing organizational form, splitting, merging, or consolidating shall be carried out in accordance with the provisions of Clause 1 of this Article.

3. Files for requesting an operating permit for medical facilities when changing location shall be carried out in accordance with the provisions of Points b, d, e, g, and h of Clause 1 of this Article, accompanied by a request form according to the model prescribed in Appendix 16 issued together with this Circular.

4. Files for requesting an operating permit for medical facilities when changing the name of the medical facility shall be carried out in accordance with the provisions of Points b, e, g, and h of Clause 1 of this Article, accompanied by a request form according to the model prescribed in Appendix 17 issued together with this Circular.

5. Files for requesting a reissued operating permit for medical facilities whose permit has been lost, damaged, or revoked according to Point a of Clause 1 of Article 48 of the Law on Medical Examination and Treatment include the original damaged permit (if available) along with a request form according to the model prescribed in Appendix 18 issued together with this Circular.

6. Files for requesting amendments to the content of operating permits for medical facilities when changing bed capacity, organizational structure, or scope of professional activities shall be carried out in accordance with Clause 3 of Article 46 of the Law on Medical Examination and Treatment, including an inventory of physical infrastructure and medical equipment and personnel files corresponding to the proposed bed capacity or scope of professional activities, accompanied by a request form according to the model prescribed in Appendix 19 issued together with this Circular.

Article 40. Procedures for Issuing, Reissuing, and Amending Operating Licenses

1. The application dossier for issuing, reissuing, and amending operating licenses for medical examination and treatment facilities as stipulated in Article 39 of this Circular shall be submitted as follows:

a) For medical examination and treatment facilities under the authority as prescribed in Clause 1, Article 45 of the Medical Examination and Treatment Law, submit one set of dossier to the Department of Medical Examination and Treatment - Ministry of Health, except for cases as prescribed in Clause 2, Article 38 of this Circular;

b) For medical examination and treatment facilities under the authority as prescribed in Clause 2, Article 45 of the Medical Examination and Treatment Law and cases as prescribed in Clause 2, Article 38 of this Circular: submit one set of dossier to the Provincial Health Department;

2. Procedure for considering applications for issuing, reissuing, and amending operating licenses:

a) After receiving the application dossier for issuing, reissuing, and amending operating licenses, the Ministry of Health or the Provincial Health Department (hereinafter referred to as the dossier receiving agency) shall send to the medical examination and treatment facility requesting issuance, reissuing, and amending operating licenses a Dossier Receipt Form according to the model prescribed in Appendix 20 issued together with this Circular;

b) Within the time limit prescribed in Points b and c, Clause 1, Article 47 of the Medical Examination and Treatment Law, from the date recorded on the Dossier Receipt Form, if there is no request for supplementation, the dossier receiving agency must consider and issue, reissue, or amend the operating license; if it does not issue, reissue, or amend the operating license, it must provide a written response stating the reasons;

c) In case the application dossier for issuing, reissuing, and amending operating licenses is not valid, within ten working days from the date recorded on the Dossier Receipt Form, the dossier receiving agency must notify the medical examination and treatment facility requesting issuance, reissuing, and amending operating licenses in writing to complete the dossier. The notification must specify which documents and contents need to be supplemented or modified;

d) Upon receipt of the written request to complete the dossier, the medical examination and treatment facility requesting issuance, reissuing, and amending operating licenses must supplement and modify according to the contents recorded in the written notice and resubmit to the dossier receiving agency. The date of receipt of the supplementary and modified dossier will be recorded on the Dossier Receipt Form. Within ten working days from the date of receipt of the supplementary and modified dossier, if the dossier receiving agency does not request further modifications or supplements, it must issue, reissue, or amend the operating license within the time limit prescribed in Points b and c, Clause 1, Article 47 of the Medical Examination and Treatment Law; if it does not issue or reissue, it must provide a written response stating the reasons;

đ) In case the medical examination and treatment facility requesting issuance, reissuing, and amending operating licenses has supplemented and modified the dossier but not in accordance with the requirements, the dossier receiving agency will notify the medical examination and treatment facility requesting issuance, reissuing, and amending operating licenses to continue completing the dossier according to Points c and d, Clause 2 of this Article;

3. The operating license shall be issued by the Minister of Health or the Director of the Provincial Health Department according to the model prescribed in Appendix 21 issued together with this Circular.

Section 3

ORGANIZATION OF ISSUING, REISSUING AND AMENDING OPERATING LICENSES FOR

1. Patients must be screened and interviewed in a private, quiet place (a separate examination room), without family members present to ensure objectivity and safety when providing information. In cases where emergency patients cannot answer the interview questions, the interview will be conducted after the patient has been stabilized.

Article 41. Organization of Assessment for Issuing, Reissuing, and Amending Operating Licenses for Medical Examination and Treatment Facilities

1. The Minister of Health shall establish an assessment team to issue and amend operating licenses for medical examination and treatment facilities under the Ministry of Health, private hospitals, or under other ministries and sectors, consisting of the following components:

a) A representative of the leadership of the Department of Medical Examination and Treatment as the Team Leader;

b) A representative of the leadership of the Legal Affairs Department as the Deputy Team Leader;

c) A representative of the leadership of the Traditional Medicine Department as the Deputy Team Leader (in the case of assessing traditional medicine medical examination and treatment facilities);

d) A representative of the Department of Medical Equipment and Construction;

đ) A representative of the Provincial Health Department where the medical examination and treatment facility is located;

e) A representative of a healthcare expert from another hospital with a relevant specialty corresponding to the scope of professional activities that the medical examination and treatment facility requests to register for the operating license;

g) Other related components if necessary (representatives of the health management agencies of ministries and sectors for medical examination and treatment facilities directly under other ministries and sectors);

h) A staff member of the Department of Medical Examination and Treatment or a staff member of the Traditional Medicine Department (in the case of assessing traditional medicine medical examination and treatment facilities) as the Secretary of the assessment team.

2. The Director of the Provincial Health Department shall establish an assessment team to issue and amend operating licenses for medical examination and treatment facilities, except for cases as prescribed in Clause 1 of this Article, as follows:

a) A representative of the leadership of the Provincial Health Department or a representative of the Standing Assessment Team prescribed in Clause 3 of this Article as the Team Leader;

b) A representative of the leadership of the Medical Practice Management Department or the Medical Services Department (for Provincial Health Departments that have not established a Medical Practice Management Department) as the Deputy Team Leader;

c) A representative of the Medical Services Department (for Provincial Health Departments that have established a Medical Practice Management Department);

d) A representative of the Human Resources Department (in the case of assessing state-owned medical examination and treatment facilities);

đ) A representative of a hospital with a relevant specialty corresponding to the scope of professional activities that the medical examination and treatment facility requests to register for the operating license (if necessary);

e) Other related components if necessary (representatives of the health management agencies of ministries and sectors for medical examination and treatment facilities directly under other ministries and sectors);

g) A staff member of the Medical Practice Management Department or the Medical Services Department (for Provincial Health Departments that have not established a Medical Practice Management Department) as the Secretary of the assessment team.

3. The Standing Assessment Team prescribed in Clause 1 of this Article is located at the Department of Medical Examination and Treatment - Ministry of Health. The Standing Assessment Team prescribed in Clause 2 of this Article is located at the Medical Practice Management Department or the Medical Services Department (for Provincial Health Departments that have not established a Medical Practice Management Department) - Provincial Health Department.

Article 42. Procedure for reviewing the issuance, reissuance, and adjustment of operating permits for medical examination and treatment facilities

1. The procedure for reviewing the issuance and adjustment of operating permits includes:

a) Reviewing legal documents; inspecting conditions regarding physical infrastructure, equipment, medical devices, and human resources organization of medical examination and treatment facilities; reviewing the scope of professional activities;

b) Preparing a review record according to the model prescribed in Appendix 22 issued together with this Circular;

c) The review 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 Provincial Health Department where the medical examination and treatment facility is located, and one copy retained at the reviewed medical examination and treatment facility;

d) The review records of medical examination and treatment facilities under the management authority of the Provincial Health Department Director shall be made in two copies: one copy retained at the Provincial Health Department and one copy retained at the reviewed medical examination and treatment facility.

2. The procedure for reviewing the reissuance of operating permits includes:

a) Checking the review file previously issued for the operating permit retained at the Ministry of Health or the Provincial Health Department or the damaged operating permit (if any);

b) Reissuing the operating permit according to the model prescribed in Appendix 21 issued together with this Circular.

3. Management of operating permits:

a) Each medical examination and treatment facility shall only be granted one operating permit;

b) Copies of the operating permit and the application file for issuing, reissuing the operating permit shall be kept at the issuing authority;

c) After granting the operating permit to a medical examination and treatment facility:

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

- The Provincial Health Department must send a notification letter to the People's Committee of the district, city district, provincial town, or provincial city where the medical examination and treatment facility has been granted the operating permit within thirty days from the date of issuance, reissuance, adjustment, or revocation of the operating permit.

Chapter IV

IMPLEMENTING PROVISIONS

Article 43. Effective Date

This Circular takes effect from January 1, 2012.

Abolish Circular No. 07/2007/TT-BYT dated May 25, 2007, guiding the practice of medicine, traditional medicine, and private medical equipment.

Article 44. Cross-References

In case the referenced documents in this Circular are replaced or amended, the amended or replaced documents shall apply.

Article 45. Implementation Organization

1. Responsibilities of the Ministry of Health:

a) The Medical Examination and Treatment Administration:

- Directing, guiding, inspecting, and auditing the implementation of this Circular nationwide;

- Building a data management system related to issuing, reissuing, revoking professional practice certificates, suspending specialized activities, and the practice of those who have been granted professional practice certificates nationwide; issuing, reissuing, adjusting, or revoking operating permits nationwide; registering for practice.

- Publicly posting relevant data on the issuance, reissuance, and revocation of professional practice certificates, suspension of specialized activities on the Ministry of Health’s electronic portal or the Medical Examination and Treatment Administration’s website.

- Coordinating with the Planning and Finance Department and related units in planning investment, upgrading infrastructure, medical equipment, and personnel for state-owned medical examination and treatment facilities under its management to meet the requirements stipulated in this Circular;

b) The Planning and Finance Department shall take the lead, coordinate with the Medical Examination and Treatment Administration and related units in planning investment, upgrading infrastructure, medical equipment, and personnel for state-owned medical examination and treatment facilities under their management to meet the requirements stipulated in this Circular.

2. Ministries and sectors with medical examination and treatment facilities operating before the effective date of this Circular shall be responsible for planning investment, upgrading infrastructure, medical equipment, and personnel for state-owned medical examination and treatment facilities under their management to meet the requirements stipulated in this Circular.

3. The People's Committee of the province shall be responsible for investing in and upgrading infrastructure, medical equipment, and personnel for state-owned medical examination and treatment facilities under its management to meet the requirements stipulated in this Circular upon the proposal of the Provincial Health Department.

4. Responsibilities of the Provincial Health Department:

a) Planning investment, upgrading infrastructure, medical equipment, and personnel for state-owned medical examination and treatment facilities under its management to meet the requirements stipulated in this Circular;

b) Directing, guiding, inspecting, and auditing the implementation of this Circular within its jurisdiction;

c) Revoking dental practice certificates for cases that were issued before the effective date of this Circular but did not comply with the provisions of Circular No. 07/2007/TT-BYT dated May 25, 2007, guiding the practice of medicine, traditional medicine, and private medical equipment issued by the Minister of Health;

d) Statistics and publicly post on the Provincial Health Department’s website the list:

- Practitioners who have been issued, reissued, or had their professional practice certificates revoked or suspended within its jurisdiction;

- Practitioners who have registered for practice within its jurisdiction;

- Medical examination and treatment facilities that have been issued, reissued, adjusted, or had their operating permits revoked or suspended within its jurisdiction.

đ) Reporting statistical data on practitioners and medical examination and treatment facilities as stipulated in Point d Clause 2 Article 42 of this Circular to the Ministry of Health (Medical Examination and Treatment Administration) every six months. Specifically, the list of practitioners who have registered for practice must be implemented in accordance with Clause 2 Article 14 of this Circular.

5. Responsibilities of medical examination and treatment facilities operating before January 1, 2012, shall plan investment and upgrade infrastructure, medical equipment, and personnel to meet the requirements stipulated in this Circular.

Article 46. Responsibility for Implementation

1. The Director of the Department of Medical Examination and Treatment, the Director of the Department of Traditional Medicine, and the Director of the Department of Legal Affairs and Inspectorate of the Ministry within their respective functions, tasks, and authorities shall be responsible for coordinating with relevant Departments, Bureaus, and General Departments to organize inspections and audits of the issuance of practice certificates and operating permits, the conduct of medical examination and treatment activities, and compliance with laws by medical examination and treatment facilities nationwide.

2. The Director of the Provincial Health Department shall be responsible for organizing inspections and audits of the issuance of practice certificates and operating permits, the conduct of medical examination and treatment activities, and compliance with laws by medical examination and treatment facilities within the managed locality.

During implementation, if there are any difficulties, they are requested to promptly reflect them to the Ministry of Health (Department of Medical Examination and Treatment) for research and resolution.