Circular No. 10/2001/TT-BYT guiding foreign investment in the field of medical examination and treatment in Vietnam

CIRCULAR

Guidelines for foreign investment in the field of medical examination and treatment in Vietnam

 

Pursuant to the Law on Health Care for the People and related legal documents guiding the implementation of this Law;

 

Pursuant to the Law on Foreign Investment in Vietnam dated November 12, 1996, the Law Amending and Supplementing Certain Provisions of the Law on Foreign Investment in Vietnam dated June 9, 2000, and related legal documents guiding the implementation of the Law on Foreign Investment in Vietnam; Decree No. 06/2000/NĐ-CP dated March 6, 2000 of the Government on cooperation with foreign investment in the fields of medical examination and treatment, education and training, scientific research;

Pursuant to the Enterprise Law and related legal documents guiding the implementation of the Enterprise Law; Decree No. 11/1999/NĐ-CP dated March 3, 1999 of the Government on goods prohibited from circulation, commercial services prohibited from implementation; goods and commercial services subject to restricted business operations, conditional business operations;

Pursuant to the Ordinance on Private Medical and Pharmaceutical Practice, Decree No. 06/CP dated January 29, 1994 on detailing certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice and related legal documents guiding the implementation of the Ordinance and the Decree;

Pursuant to Circular No. 08/2000/TT-BLDTBXH dated March 29, 2000 of the Ministry of Labor, Invalids and Social Affairs guiding the issuance of Work Permits for foreigners working at enterprises and organizations in Vietnam;

After receiving the opinion of the Ministry of Planning and Investment in Document No. 2096/BKH-PLĐT dated April 9, 2001, the Ministry of Health guides foreign investment in the field of medical examination and treatment in Vietnam as follows:

PART I

GENERAL PROVISIONS

Article 1. Foreign organizations and individuals may invest in the field of medical examination and treatment in Vietnam under the following types of medical examination and treatment and forms of investment:

1. Types of medical examination and treatment:

1.1. Hospitals:

a) General hospitals.

b) Specialized hospitals.

1.2. Clinics, near-clinical facilities:

a) General clinics: Clinics with multiple specialties (at least two).

b) Specialized clinics.

c) Maternity homes.

d) Near-clinical specialized clinics.

1.3. Services supporting the transportation of patients abroad.

Medical examination and treatment facilities with foreign investment or other facilities that meet the conditions stipulated in Clause 14, Article 9 of this Circular may register services supporting the transportation of patients abroad.

2. Forms of investment:

a) Joint ventures.

b) 100% foreign capital.

c) Business cooperation based on a business cooperation contract.

Article 2. Vietnamese organizations eligible to cooperate with foreign entities to establish medical examination and treatment facilities with foreign investment include:

1. Hospitals, general clinics, specialized clinics, medical examination and treatment units that are self-financing public service units of Vietnam.

2. Public-private partnership hospitals, general clinics, specialized clinics, midwifery houses.

3. Private hospitals, general clinics, specialized clinics, private midwifery houses.

4. Entities specified in Article 2 of Decree No. 24/2000/NĐ-CP dated July 31, 2000 of the Government detailing the implementation of the Law on Foreign Investment in Vietnam.

Article 3. Medical examination and treatment facilities with foreign investment must ensure compliance with the conditions stipulated by the laws on foreign investment in Vietnam, the laws on private medical and pharmaceutical practice, and other relevant laws, and implement technical regulations issued by the Ministry of Health.

Article 4.

1. The Ministry of Planning and Investment shall consider issuing an Investment License for medical examination and treatment facilities with foreign investment after receiving a written agreement from the Ministry of Health based on the initial investment project's review, which is consistent with the planning of the medical examination and treatment network organization, the target population served in the area where the medical examination and treatment facility with foreign investment is located.

2. After the medical examination and treatment facility with foreign investment has been constructed and completed in terms of equipment, infrastructure, organizational structure, and personnel, the Ministry of Health will assess and issue a Certificate of Eligibility for Medical Examination and Treatment Practice.

3. Only after obtaining the Certificate of Eligibility for Medical Examination and Treatment Practice issued by the Ministry of Health can the medical examination and treatment facility with foreign investment commence operations.

Article 5. Medical examination and treatment facilities with foreign investment must operate within the scope of professional activities permitted by the Ministry of Health. The fees for medical examination and treatment must be commensurate with the quality of equipment, infrastructure, and the professional qualifications of doctors and healthcare staff.

Article 6.

1. Medical examination and treatment facilities with foreign investment must reapply for a new Certificate of Eligibility for Medical Examination and Treatment Practice in the following cases:

- Changing the form of investment or type of medical examination and treatment.

- Splitting or merging medical examination and treatment facilities.

- Changing the location of medical examination and treatment practice.

- The Certificate of Eligibility to Practice has expired.

2. While the Certificate of Eligibility for Medical Examination and Treatment Practice remains valid, if there is a change in the investor or director, the medical examination and treatment facility must report to the Minister of Health. The new director of the medical examination and treatment facility must hold a Medical Examination and Treatment Practice Certificate.

Article 7. Medical examination and treatment facilities with foreign investment must pay fees and charges for the assessment of eligibility for practice according to the provisions of the law.

Chapter II

PROVISIONS AND SCOPE OF SPECIALIZED ACTIVITIES OF HEALTH CARE FACILITIES WITH FOREIGN INVESTMENT

OF FOREIGN-INVESTED HEALTH CARE FACILITIES

Article 8. General Conditions:

1. Health care facilities with foreign investment must apply modern methods in diagnosis, treatment, and patient care at a high quality level, ensuring effectiveness and safety for patients.

2. Health care facilities with foreign investment must have modern medical equipment suitable for each type of health care service currently used worldwide. The infrastructure and medical staff must be compatible with modern medical equipment and the approved scope of specialized technical activities; they must have emergency medicine cabinets and anti-shock kits (as per Appendix 1), and ensure adequate electricity, water, sanitation facilities, fire safety equipment, etc., to maintain environmental hygiene and properly manage waste according to legal regulations.

3. The directors of hospitals and health care facilities (commonly referred to as hospital directors, heads of general clinics, heads of specialty clinics, heads of laboratories, and heads of maternity wards) with foreign investment must hold a Medical Practice Certificate issued by the Ministry of Health. Doctors and healthcare personnel working at health care facilities with foreign investment must possess appropriate academic degrees and certificates corresponding to their assigned tasks and must have more than three years of specialized practice experience.

4. Health care facilities with foreign investment must have plans for technology transfer cooperation and training of Vietnamese staff.

Article 9. Specific Conditions: In addition to the general conditions stipulated in Article 8 of this Circular, health care facilities with foreign investment must meet the following specific conditions:

1. Hospitals: Hospitals are health care facilities providing both inpatient and outpatient treatment. They can be either general hospitals or specialized hospitals.

1.1. Conditions for hospitals to be permitted to operate health care services:

a) The hospital director must be a doctor holding a Medical Practice Certificate issued by the Ministry of Health allowing registration of the hospital.

Department heads in the hospital must be specialists who have practiced for five years at legally recognized health care facilities, including three years of specialized practice.

b) The hospital must have at least twenty-one beds.

c) The organization and staff must be commensurate with the scale of the hospital.

d) The hospital must have:

- An outpatient department.

- An emergency department.

- Treatment departments.

- Ancillary departments.

1.2. Scope of Specialized Activities: Carry out activities strictly in accordance with the approved list of specialized activities by the Ministry of Health. The hospital must admit patients in critical condition and only transfer them to another hospital after initial emergency treatment.

2. General Clinics: A general clinic is a health care facility comprising multiple specialty clinics (at least two) under the unified management of a director.

2.1. Conditions for general clinics to be permitted to operate health care services:

a) The general clinic director must be a doctor holding a Medical Practice Certificate issued by the Ministry of Health allowing registration of the general clinic.

Specialty clinic heads within the general clinic must be specialists who have practiced for five years at legally recognized health care facilities, including three years of specialized practice.

b) Infrastructure: Each specialty clinic within the general clinic must ensure sufficient space, equipment, and conditions as specified in this Circular. Additionally, the general clinic must have waiting rooms, emergency rooms, and observation rooms (with a maximum of ten beds and no longer than 24 hours of observation).

2.2. Scope of Specialized Activities: Operate within the approved list of specialties.

3. Internal Clinics: Internal clinics include:

- Comprehensive internal clinics.

- Internal system clinics.

- Family clinics.

- Telehealth consultation clinics.

3.1. Conditions for internal clinics to be permitted to operate health care services:

a) The clinic head must be a doctor holding a Medical Practice Certificate issued by the Ministry of Health allowing registration of the internal clinic.

b) Comprehensive internal clinics, internal system clinics, and family clinics must have specialized equipment suitable for their scope of practice.

There must be a separate examination room of at least 10 square meters, with an examination bed and desk.

For telehealth consultation clinics, the provisions of point b, Clause 3.1 of this Article do not apply.

3.2. Scope of Specialized Activities:

a) Comprehensive internal clinics and family clinics:

- Health counseling and family planning.

- Health management.

- Initial first aid, emergency care, diagnosis, prescription, and treatment of common illnesses without performing specialized procedures. Cases beyond their capacity should be referred to specialty clinics or higher-level facilities.

- Outpatient surgery: initial fracture care without casting, no minor surgeries.

- Obstetrics: prenatal care, pregnancy management, no delivery assistance.

- Dentistry: no tooth extraction.

- Otorhinolaryngology: otoscopy, rhinoscopy, laryngoscopy, no incision for middle ear abscesses.

- Sample collection for laboratory tests, no biopsy, no puncture.

- Electrocardiogram, ultrasound, etc., do not require separate certification but must have a certificate of professional training and practical experience in these fields from legally recognized health care facilities, certified by the competent authority to permit recording within the scope of practice.

b) Internal system clinics: Diagnosis and treatment of diseases within the approved specialty.

4. Specialty Surgical Clinics:

4.1. Conditions for surgical clinics to be permitted to operate health care services:

a) The clinic head must be a doctor holding a Medical Practice Certificate issued by the Ministry of Health allowing registration of the surgical clinic.

Surgical specialty clinics must have minor surgery tools and operating rooms, emergency rooms, and observation rooms, with particular attention to infection control techniques.

4.2. Scope of Specialized Activities:

- Initial surgical first aid and emergency care.

- Examination and treatment of common wounds.

- Casting of small bone fractures.

- Removal of casts as directed by the physician who applied them.

- Minor hemorrhoid ligation, cyst excision, small cyst removal.

- No drainage of large diffuse abscesses.

5. Specialty Obstetric-Gynecological and Family Planning Clinics:

5.1. Conditions for a specialized obstetrics and gynecology - family planning clinic to be permitted to conduct general outpatient services and treatment:

a) The head of the clinic must be a doctor with a medical practice certificate for a specialized obstetrics and gynecology - family planning clinic issued by the Ministry of Health.

b) There must be a separate examination room with an area of at least 10m², equipped with an examination table, examination tools, and instruments for obstetric procedures. In addition to the examination room, there must be a procedure room.

5.2. Scope of professional activities:

- Providing health education and family planning counseling.

- Initial emergency care for obstetric and gynecological conditions.

- Prenatal examinations and pregnancy management.

- Routine gynecological examinations and treatments.

- Inserting vaginal medication.

- Treating cervical erosion by cauterization.

- Performing cervical cytology tests.

- Inserting intrauterine devices.

- Inducing abortion up to 15 days post-conception.

- Performing male sterilization without using a knife.

- Not performing induced abortion, removal of intrauterine devices, or female sterilization.

- Not delivering babies at the clinic.

6. Specialized dental - oral and maxillofacial clinic:

6.1. Conditions for a specialized dental - oral and maxillofacial clinic to be permitted to conduct outpatient services and treatment:

a) The head of the clinic must be a doctor with a medical practice certificate for a specialized dental - oral and maxillofacial clinic issued by the Ministry of Health.

b) There must be sufficient minor surgery rooms and workspaces suitable for the scope of practice.

6.2. Scope of professional activities:

- Routine examinations and initial emergency care for oral and maxillofacial injuries.

- Performing minor surgical procedures to repair small scars under 2cm on the face.

- Correcting jaw misalignment.

- Surface laser treatment.

- Treating periodontal diseases.

- Draining abscesses, removing tartar, and extracting teeth.

- Making dentures and false teeth.

7. Specialized otolaryngology clinic:

7.1. Conditions for a specialized otolaryngology clinic to be permitted to conduct outpatient services and treatment: The head of the clinic must be a doctor with a medical practice certificate for a specialized otolaryngology clinic issued by the Ministry of Health.

7.2. Scope of professional activities:

- Initial emergency care for ear, nose, and throat conditions.

- Routine examinations and treatments:

+ Sinusitis, sinus puncture, and fluid aspiration from cysts.

+ Incision and drainage of acute middle ear infections.

+ Incision and drainage of peritonsillar abscesses.

+ Simple polyp, benign tumor, and cyst excisions in the ear, nose, and throat region.

+ Stopping nasal bleeding.

+ Removing foreign objects from the ear, nose, and throat. Not removing foreign objects from the trachea or esophagus.

+ Treating throat lesions with heat or laser.

+ Suturing wounds in the head and neck region under 5cm.

+ Adenoidectomy.

8. Specialized ophthalmology clinic:

8.1. Conditions for a specialized ophthalmology clinic to be permitted to conduct outpatient services and treatment: The head of the clinic must be a doctor with a medical practice certificate for a specialized ophthalmology clinic issued by the Ministry of Health.

8.2. Scope of professional activities:

- Initial emergency care and routine eye examinations and treatments.

- Subconjunctival injections, periocular injections, and retrobulbar injections.

- Removing foreign objects from the conjunctiva, treating styes, and performing blepharoplasties.

- Lacrimal duct irrigation.

9. Specialized plastic surgery clinic: This facility provides aesthetic services performed by physicians.

9.1. Conditions for a specialized plastic surgery clinic to be permitted to operate:

a) The head of the clinic must be a doctor with a medical practice certificate for a specialized plastic surgery clinic issued by the Ministry of Health.

b) The facility must ensure sterility, have adequate operating rooms, recovery rooms, and waiting areas.

c) If the procedures alter facial recognition, they must be approved by the police authority.

9.2. Scope of professional activities:

- Tattooing lips and eyelids, acne extraction, and other blood-bleeding cosmetic services.

- Hair transplantation.

- Cheek augmentation and rhinoplasty.

- Facelift surgery.

- Treating upper and lower eyelid wrinkles, creating double eyelids from single eyelids.

10. Specialized rehabilitation and physical therapy clinic:

10.1. Conditions for a specialized rehabilitation and physical therapy clinic to be permitted to conduct outpatient services and treatment: The head of the clinic must be a doctor with a medical practice certificate for a specialized rehabilitation and physical therapy clinic issued by the Ministry of Health.

10.2. Scope of professional activities:

- Caring for central and peripheral nervous system paralysis syndromes.

- Caring for chronic musculoskeletal diseases.

- Postoperative care requiring continued functional rehabilitation.

- Implementing techniques:

+ Massage, acupressure, acupuncture.

+ Approved physical therapy methods.

+ Therapeutic exercises.

11. Diagnostic imaging department: The diagnostic imaging department is a facility that contributes to disease diagnosis and treatment monitoring through X-ray and ultrasound equipment.

11.1. Conditions for a diagnostic imaging department to be permitted to conduct outpatient services and treatment:

a) The head of the diagnostic imaging department must be a doctor with a medical practice certificate for a specialized diagnostic imaging clinic issued by the Ministry of Health.

b) There must be sufficient personal protective equipment, and the X-ray room must meet radiation safety standards and be certified for radiation safety. The infrastructure must ensure absolute safety; there must be waiting rooms, film processing rooms, printing rooms, and reading rooms. The equipment room must be at least 3.5 meters high, with barium-coated walls, lead-lined doors, and a raised floor.

11.2. Scope of professional activities:

- Conducting X-rays, computed tomography, and magnetic resonance imaging.

- Performing Doppler ultrasound, conventional ultrasound, and diagnostic endoscopy.

- Not using intravenous contrast media.

- Not performing ultrasound-guided interventions, laparoscopic surgeries, bronchoscopies, or angiographic interventions.

12. Laboratory: The laboratory is a facility that assists in diagnosis and treatment monitoring, including hematology, biochemistry, microbiology, and histopathology.

12.1. Conditions for a laboratory to be permitted to operate:

a) The head of the laboratory must be a doctor, pharmacist, or biologist/chemist with a medical practice certificate for a specialized laboratory issued by the Ministry of Health.

b) The infrastructure must meet laboratory standards, with architectural design and organization ensuring workplace safety according to laboratory regulations. Attention should also be paid to auxiliary facilities such as electricity, water supply, and fire prevention.

12.2. Scope of professional activities:

Conducting hematological, biochemical, microbiological, parasitological, and histopathological (microscopic) tests.

13. Midwife House: A midwife house is a childbirth facility responsible for managing and providing prenatal care.

13.1. Conditions for a midwife house to be permitted to operate:

a) The head of the midwife house must be a doctor holding a Medical Practice Certificate issued by the Ministry of Health and must practice full-time.

b) Infrastructure: It must have delivery waiting rooms, delivery rooms, and post-delivery rooms that ensure sterile and well-ventilated conditions.

13.2. Scope of professional activities:

- Prenatal examinations and pregnancy management.

- Initial emergency care and obstetric first aid.

- Administering tetanus prophylaxis according to regulations for each pregnant woman.

- Urine protein testing.

- Normal delivery assistance.

- Episiotomy and suturing of the perineum when indicated, suturing of first-degree perineal lacerations.

- Abortion up to 12 weeks.

- Removal of retained placenta after delivery or miscarriage.

- May assist with difficult deliveries, vacuum extraction, and forceps delivery.

- Insertion of intrauterine devices, but not removal of them, and cannot perform category 1 obstetric procedures.

14. Support Services for Patient Transport Overseas: Conditions for being permitted to operate such services:

- Must be a foreign-invested medical facility. The directors of these facilities must hold a Medical Practice Certificate.

- Must have sufficient specialized critical care doctors and medical staff, transportation means, and adequate medical equipment, tools, and emergency medications to ensure patient safety during transport.

- Must have a contract with an airline service company for patient transport.

Chapter III

RECORDS, PROCEDURES AND AUTHORITY FOR ISSUING PRACTICE LICENSES

MEDICAL PRACTICE LICENSES

Article 10. Records and Procedures:

1. Individuals applying for a foreign-invested medical facility are foreigners or overseas Vietnamese:

a) Documents:

- Application for issuance of a Medical Practice Certificate.

- Commitment letter to comply with Vietnamese laws on health and other relevant Vietnamese laws.

- Certified copies of specialty diplomas, certificates, or proof of more than five years of practical experience from the home country (with notarized certification).

- Work permit issued by the provincial Department of Labor, Invalids, and Social Affairs for foreign workers employed within their jurisdiction.

b) Procedure: The application for issuance of a Medical Practice Certificate is submitted to the Ministry of Health (Department of Treatment). Within thirty days of receiving complete and valid applications, the Ministry of Health will issue a Medical Practice Certificate or notify in writing if it decides not to issue one.

2. Individuals applying for a foreign-invested medical facility are Vietnamese citizens:

a) Records: Follow the provisions set forth in Circular No. 19/2000/TT-BYT dated November 24, 2000, issued by the Minister of Health regarding guidelines for issuing Medical Practice Certificates.

b) Procedure: After fifteen days from the date the Ministry of Health receives a complete and valid application, individuals will be notified of the time for the examination to obtain a Medical Practice Certificate. The Ministry of Health will organize examinations to issue Medical Practice Certificates every third month of each quarter.

Article 11. Authority to Issue Medical Practice Certificates:

The Minister of Health will issue Medical Practice Certificates to individuals who meet the requirements stipulated in this Circular to register foreign-invested medical facilities. These certificates are valid nationwide and have a validity period of five years from the date of issuance. Five years after obtaining a Medical Practice Certificate, the holder must submit to the Ministry of Health a certificate confirming participation in a refresher course to renew the Medical Practice Certificate.

Chapter IV

RECORDS, PROCEDURES AND AUTHORITY FOR ISSUING CERTIFICATES

OF ELIGIBILITY FOR MEDICAL PRACTICE LICENSES

Article 12. Application for Issuance of a Certificate of Eligibility for Medical Practice Licenses.

Article 13. Procedures for Review to Issue a Certificate of Eligibility for Medical Practice Licenses:

1. The facility applying for a Certificate of Eligibility for Medical Practice Licenses must submit the application to the Ministry of Health (Department of Treatment).

2. Content of the review record:

All documents must be submitted with original copies and certified translations into Vietnamese, and all copies and translations must be notarized.

Article 14. Authority to Issue a Certificate of Eligibility for Medical Practice Licenses:

1. The Minister of Health issues a Certificate of Eligibility for Medical Practice Licenses to foreign-invested medical facilities.

2. The Ministry of Health establishes a Review Board to assist the Minister in reviewing eligibility for issuing Certificates of Eligibility. The Board is chaired by a Deputy Minister, with the Director of the Department of Treatment as the Vice-Chairman, a representative from the Vietnam Association of Physicians and Pharmacists, and other members. During the review process, there will be participation from a representative of the Provincial Health Department and a representative from the foreign-invested medical facility.

Article 15. Validity Period of the Certificate of Eligibility for Medical Practice Licenses:

1. The Certificate of Eligibility for Medical Practice Licenses issued by the Minister of Health is valid for five years from the date of issuance.

2. Three months before expiration, facilities must apply for renewal.

2.1. Records:

+ Application for renewal.

+ Previously issued Certificate of Eligibility for Medical Practice Licenses.

+ Report on the operation of the foreign-invested medical facility over the past five years: The report should detail specific operational activities related to medical treatment over the past five years, infrastructure and medical equipment status, technical advancements, strengths, weaknesses, corrective measures, and future development plans...

+ Health check certificates for the facility director, department heads, doctors, medical staff, and other employees.

2.2. Procedure: The records are submitted to the Ministry of Health (Department of Treatment), which will establish a Review Team to consider the renewal of the Certificate of Eligibility for Medical Practice Licenses.

3. The Certificate of Eligibility for Medical Practice Licenses is issued and kept as follows: The Certificate issued by the Minister of Health is made in four copies: one copy sent to the Provincial Health Department, one copy sent to the applicant, and two copies retained by the Ministry of Health.

Chapter V

RIGHTS AND OBLIGATIONS OF MEDICAL FACILITIES

WITH FOREIGN INVESTMENT CAPITAL

Article 16. In addition to the rights and obligations prescribed in Chapter III of the Private Medical and Pharmaceutical Practice Ordinance and Article 16 of Decree No. 06/CP dated January 29, 1994 of the Government on detailing certain provisions of the Private Medical and Pharmaceutical Practice Ordinance, Article 18, 19, 20, 21, 22, and 23 of Decree No. 06/2000/NĐ-CP dated March 6, 2000 of the Government on cooperation with foreign investment in the fields of medical examination and treatment, education and training, and scientific research, foreign-invested medical examination and treatment establishments have the following rights and obligations:

1. Rights:

- Foreign-invested hospitals are permitted to organize pharmacies to provide medicines for outpatients, in accordance with the relevant legal regulations. If not establishing a pharmacy, the hospital must have a hospital pharmacy department to supply medicines for inpatients.

- Doctors, pharmacists, and healthcare staff working in foreign-invested medical examination and treatment establishments are entitled to long-term study according to the state's student recruitment regulations to improve their skills; regularly participate in professional activities and specialized training to update knowledge, especially dangerous diseases (malaria, cholera, typhoid fever, HIV/AIDS...). The provincial Department of Health (referred to collectively as the province) is responsible for coordinating with the Provincial Medical and Pharmaceutical Association to organize training, instruction, and skill improvement, as well as knowledge updates for the aforementioned individuals.

- Medical examination and treatment establishments and individuals with outstanding achievements in serving patients shall be commended and rewarded according to the general system of the Socialist Republic of Vietnam.

- The director of foreign-invested medical examination and treatment establishments must bear legal responsibility before Vietnamese law for all medical examination and treatment activities of the establishment.

- Foreign-invested medical examination and treatment establishments are entitled to incentives and investment preferences stipulated in Articles 18, 19, 20, 21, 22, and 23 of Decree No. 06/2000/NĐ-CP dated March 6, 2000 of the Government.

2. Obligations:

- They must fulfill tax and financial obligations like other foreign-invested enterprises and enjoy investment incentives under Vietnamese laws on foreign investment.

- They are encouraged to allocate a portion of annual profits to organize free medical examinations and treatments or support for the poor and disaster victims.

- They must display signs in compliance with regulations, publicly post fee schedules, detailed scope of practice; operate within the approved scope of practice and fee schedule. Foreign-invested medical examination and treatment establishments must establish a fee schedule and report it to the Ministry of Health for approval.

- They are prohibited from prescribing, using drugs, or utilizing medical equipment that has not been authorized for circulation, or applying new techniques without permission from the Ministry of Health.

- They have the obligation to participate in disease prevention and control programs and national health programs. It is strictly forbidden to exploit free-of-charge drugs or equipment provided by the state (under state subsidy) for sale to profit.

- They must sign contracts with state-owned medical examination and treatment establishments to receive technical support and transfer patients when required.

- They must comply with the Hospital Regulations issued together with Decision No. 1895/1997/BYT-QĐ dated September 19, 1997 of the Minister of Health (medical records must be written in Vietnamese or bilingual Vietnamese and another foreign language chosen by the medical examination and treatment establishment), implement special allowances for particularly difficult professions as state medical examination and treatment establishments, and other related legal provisions.

Chapter VI

STATE MANAGEMENT IN TERMS OF SPECIALIZATION AND TECHNICAL SKILLS FOR

FOREIGN-INVESTED MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 17.

- The Ministry of Health performs state management functions in terms of specialization and technical skills for foreign-invested medical examination and treatment establishments nationwide.

- The provincial Department of Health is responsible for state management in terms of specialization and technical skills for foreign-invested medical examination and treatment establishments within its jurisdiction.

Article 18. Foreign-invested medical examination and treatment establishments must submit regular quarterly, semi-annual, and annual reports to the provincial Department of Health and the Ministry of Health in accordance with the Hospital Regulations issued together with Decision No. 1895/1997/BYT-QĐ dated September 19, 1997 of the Minister of Health.

- The periodic reports submitted by the provincial Department of Health to the Ministry of Health must include local management of foreign-invested medical examination and treatment establishments.

- Each year, the provincial Departments of Health must submit separate reports on foreign-invested medical examination and treatment establishments.

Chapter VI

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 19. The Ministry of Health will organize regular or spot inspections to check compliance with legal provisions regarding medical practice at foreign-invested medical examination and treatment establishments nationwide.

The provincial Department of Health will organize regular or spot inspections to check compliance with legal provisions regarding medical practice at foreign-invested medical examination and treatment establishments within its jurisdiction.

Foreign-invested medical examination and treatment establishments must comply with and facilitate inspection and audit activities at their premises.

Article 20. Foreign-invested medical examination and treatment establishments and individuals practicing in these establishments who violate the provisions of this Circular, professional technical regulations, or other related legal provisions will be subject to legal sanctions.

Chapter VIII

IMPLEMENTING PROVISIONS

Article 21. This Circular takes effect 15 days after its issuance date and replaces Circular No. 22/BYT-TT dated December 29, 1994 of the Minister of Health on guiding foreign investment in the field of medical examination and treatment in Vietnam.

Article 22. Foreign-invested medical examination and treatment establishments that have obtained certificates confirming they meet the criteria and conditions for establishing foreign-invested medical examination and treatment establishments as stipulated in Circular No. 22/BYT-TT dated December 29, 1994 of the Minister of Health must complete procedures to obtain new certificates according to this Circular five months before the expiration date./.