As the demand for healthcare services has significantly increased over the past few years, the businesses of medical clinics in Vietnam have attracted several investors. However, the operations of medical clinics have a considerable impact on the safety and health of humans, which makes this business sector subject to strict requirements and conditions set forth by the prevailing laws of Vietnam. Through this article, ALB & Partners would like to provide a comprehensive insight into the prevailing requirements and conditions for setting up a medical clinic in Vietnam.
I. LEGAL DOCUMENTS:
- The Law on Medical Examination and Treatment of 2009 (the “LOMDT 2009”);
- Decree No. 87/2011/ND-CP dated 27 September 2011 promulgated by the Government on detailing and guiding the implementation of the Law on Medical Examination and Treatment (“Decree 87”);
- Decree No. 109/2016/ND-CP dated 01 July 2016 promulgated by the Government on regulating the issuance of practicing certificates for practitioners and the issuance of operating licenses for medical examination and treatment establishments (“Decree 109”);
- Decree No. 155/2018/ND-CP dated 12 November 2018 promulgated by the Government on amending and supplementing regulations in regard to investment conditions within the scope of state administration of the Ministry of Health (“Decree 155”).
II. PROCEDURES:
In order to establish a polyclinic or a specialized clinic, it is compulsory to apply for an enterprise registration certificate or an investment certificate as prescribed by law and to apply for an operating license issued by the Minister of Health or the Director of the Department of Health or issued by the Department of Health.
III. CONDITIONS FOR THE ISSUANCE OF AN OPERATING LICENSE:
III.1. As for a polyclinic:
- The required scale of a polyclinic:
- Having at least 02 of the 04 specialized departments of internal medicine, surgery, obstetrics, and pediatrics;
- Have a paraclinical department (units of testing and image diagnostic)
- Facilities:
- Having a fixed location (except for the cases of organizing mobile medical examination and treatment);
- Satisfying the requirements of radiation safety, hospital waste management, and firefighting and fire prevention according to law;
- Having a sterilization area for treating medical instruments for reuse, otherwise concluding contracts with another medical establishment for the purpose of treating used medical instruments;
- Having a place for patient reception, emergency and patient stay rooms, specialized consulting rooms, and minor surgery rooms (if any minor surgery is carried out.
- Rooms in a polyclinic shall satisfy the requirements of the minimum area as follows:
- The emergency room shall have an area of at least 12 m2;
- The patient stay room shall have an area of at least 15 m2 with at least 2 patient beds. If the patient stay room has 3 or more patient beds, the area for each bed shall be at least 5 m2;
- Specialized consulting rooms and the minor surgery room have an area of at least 10 m2.
3. Medical equipment:
- A polyclinic needs to be sufficiently equipped and procured with medical equipment, tools, instruments, consumables, medicines, etc., in compliance with its registered scope of professional practices and its registered list of medical techniques;
- If a polyclinic has the function of examining and treating occupational diseases, it shall have at least a biochemistry laboratory department;
- Additionally, a polyclinic is required to have anti-shock first aid kits and sufficient specialized emergency drugs.
4. Personnel:
- The number of full-time doctors shall account for at least 50% of the total number of doctors in the polyclinic;
- The persons in charge of specialized rooms and paraclinical department (units of testing and image diagnostic) that are affiliated with the polyclinic, shall work on a full-time basis;
- The number of personnel, the arrangement of personnel, and the professional titles in a polyclinic shall adhere to relevant regulations adopted by the Minister of Health;
- In addition to the persons in charge of professional technique in a polyclinic, other persons in the polyclinic who wish to carry out medical practices are also required to obtain practicing certificates, and the assignments they factually practice shall also be in correspondence to the scope of professional practice prescribed in their certificates.
Legal basis: Article 25 of Decree 109
III.2. As for a specialized clinic:
- Facilities:
- Having a fixed location (except for the cases of organizing mobile medical examination and treatment);
- Satisfying the requirements of radiation safety, hospital waste management, and firefighting and fire prevention according to law;
- Having a sterilization area for treating medical instruments for reuse, otherwise concluding contracts with another medical establishment to treat used medical instruments;
- If any operation is conducted, including implanting operation, acupuncture, massage, or acupressure, the operation room shall be located in a separate area. The area of the operation room shall be sufficient for performing specialized techniques;
- If the specialized clinic conducts both upper and lower gastro-endoscopic techniques, it shall have 02 separate rooms;
- Having a biochemistry laboratory department in case of diagnosing and treating occupational diseases;
- Having an exam room or treatment with a minimum area of 10 m2 and a place for patient reception (excluding clinics providing services of medical examination and healthcare consultancy or clinics providing healthcare consultancy by means of information technology and telecommunications). Particularly, a surgery clinic or a cosmetological clinic shall have a patient stay room with a minimum area of 12 m2; a clinic of rehabilitation shall have a rehabilitation room with a minimum area of 10 m2; a clinic of HIV/AIDS treatment shall have the minimum area of 18 m2 (excluding the waiting area) and be divided into 2 rooms for carrying out the examination and treatment;
- Moreover, depending on the registered scope of professional practices, a specialized clinic will be additionally subject to the following requirements:
- If any operation is conducted, including implanting operation, the operation room shall have an area of at least 10 m2;
- If any operation is conducted, including implanting operation, the operation room shall have an area of at least 10 m2;
- If any gynecological examination or examination of sexually transmitted diseases is conducted, the consulting room shall have an area of at least 10 m2;
- If the family planning techniques are performed, the room specialized for such activities shall have an area of at least 10 m2;
- The room for forming a surgical cast shall have an area of at least 10 m2;
- The room for therapeutic exercise shall have an area of at least 20 m2;
- For an odonto-stomatology clinic having more than 01 dental chair, the space for each dental chair must be at least 5 m2;
- Specialized clinics using radiological equipment (including dental X-ray equipment mounted on dental chairs) must satisfy radiation safety requirements;
- A clinic of HIV/AIDS treatment providing antiretroviral drugs (ARV) shall have a place for antiretroviral drugs storage and dispersal which satisfies the requirements specified by the Minister of Health.
- Medical equipment:
- Being sufficiently equipped with medical equipment, tools, and instruments in compliance with its registered scope of professional practices;
- In the case of a clinic specializing in examining and treating occupational diseases, it shall have at least a biochemistry laboratory department;
- Having anti-shock first aid kits and sufficient specialized emergency drugs.
- Personnel:
- a) The person in charge of professional technique in a specialized clinic shall fulfill the following requirements:
- Being a doctor with a practicing certificate in correspondence with at least one of the registered specialized practice areas;
- Having worked as a medical practitioner in the specialized practice area herein for at least 54 months;
- Moreover, as for the following types of specialized clinics, the persons in charge shall be additionally subject to the following requirements:
- As for a clinic of rehabilitation: being a doctor with a practicing certificate in correspondence with physical therapy or rehabilitation;
- As for a clinic for drug rehabilitation: being a psychiatric doctor or a general practitioner with a certificate of training in psychiatry or a traditional medicine practitioner with a certificate of training in drug rehabilitation using traditional medicine;
- As for a clinic of HIV/AIDS treatment: being a doctor with a specialization in infectious disease or a general practitioner with a certificate of training in HIV/AIDS treatment;
- As for a clinic of traditional medicine: Being a traditional medicine practitioner (doctor or physician);
- As for a clinic of traditional diagnosis and treatment: Being an herb doctor or a practitioner who is granted a certificate of traditional medicine prescription or traditional medical treatment;
- As for a clinic of dietetics: Being a nutrition expert or a general practitioner with a certificate of training in dieting, a preventive medicine doctor with a certificate of training in dieting, a bachelor in dieting; or a traditional medicine doctor with a certificate of training in dieting or a bachelor in dieting; or a physician with a certificate of training in dieting;
- As for a clinic of cosmetics: Being a plastic surgeon or a Cosmetological doctor or a cosmetic surgeon.;
- As for a clinic of andrology: Being an andrological doctor or a general doctor with a certificate of training in andrology;
- As for a clinic of occupational disease: being an occupational medicine doctor with a practicing certificate or a general doctor with a practicing certificate and a certificate of training in occupational disease;
- As for a laboratory: Being a doctor or a physician specialized in testing with a bachelor’s degree or higher and a practicing certificate for testing; or a chemical or biological bachelor, or a pharmacist with a bachelor’s degree. This requirement applies to those who are recruited to work in the laboratory before this Decree takes effect and are physicians who are granted practice certificates for testing.;
- As for a clinic of image diagnosis or an X-ray room: Being an image diagnosis doctor or have a bachelor’s degree in X-ray therapy or higher, or have a practicing certificate.
- b) In addition to the persons in charge of professional technique in a specialized clinic, other persons in the clinic who wish to carry out medical practices are also required to obtain practicing certificates, and the assignments they conduct in fact shall also be in correspondence to the scope of professional practices prescribed in their certificates.
Legal basis: Article 26 of Decree 109
IV. APPLICATION PROCEDURE:
Step 1: Setting up an enterprise
In the case of state-owned clinics, establishment decisions shall be required. As for private clinics, the head of such an establishment will be responsible to apply for an Enterprise Registration Certificate or an Investment Certificate in the case of a foreign-invested medical examination and treatment establishment.
Step 2: Preparing an application dossier and applying for the issuance of an operating license
The documents in the application dossier will be prepared in accordance with Section V below.
Step 3: Liaising with the inspectorates of the Ministry of Health or the Department of Health
After examining the legitimacy of the application dossier, and within 45 working days from the date of dossier receipt, an officer of the Ministry of Health or the Department of Health will set up a team of inspectorates to directly inspect the medical establishment.
During the inspection of the establishment, it is necessary to clarify all the issues that may be raised by the team of inspectorates if any as well as to ensure that the declarations undertaken in the application documents are accurate and meet the requirements and conditions as prescribed by law.
Based on the dossier and the actual inspection, the Ministry of Health or the Department of Health will decide whether to grant a license to the establishment.
Legal basis: Article 45 of Decree 109
Step 4: Receiving the result of this procedure.
V. APPLICATION DOSSIER:
The application dossier for requesting the issuance of an operating license for a medical examination and treatment establishment shall contain the following component documents:
| No. | Name of the document | Quantity and format |
| 1 | Application form | 01 original |
| 2 | A valid copy of the followings: As for a state-owned medical establishment: An establishment decision or a document indicating the name of the medical establishment issued by a competent authority or As for a private medical establishment: An enterprise registration certificate, orAs for a foreign-invested healthcare establishment: An investment certificate. | 01 copy |
| 3 | Valid copies of practicing certificates of the persons in charge of the professional technique of the establishment; and/or of the persons in charge of specialized departments of the establishment | 01 copy of each document |
| 4 | A list for registration of practitioners at the medical examination and treatment establishment (including registration of practitioners, and persons practicing medical profession at the establishment but not required to obtain practicing certificates) | 01 original |
| 5 | A declaration of facilities, medical equipment, organization, and personnel of the medical examination and treatment establishment | 01 original |
| 6 | Documents proving that the medical establishment satisfies the requirements for facilities, medical equipment, and organization in correspondence with the scope of professional practices of a certain form of organization as prescribed by law | 01 original |
| 7 | A list of medical practices area and medical techniques provided by the medical establishment which is prepared in accordance with an official schedule adopted by the Minister of Health; | 01 original |
| 8 | As for an establishment providing emergency transportation services: a valid copy of the contract on professional support for the hospital. In the case of providing services of transporting patients abroad: a valid copy of the contract on patient transportation signed with an aviation service company. | 01 copy of each document |
Legal basis: Article 43 and Article 44 of Decree 109
VI. LICENSING AUTHORITIES:
- The Ministry of Health shall be the competent authority to issue operating licenses for clinics that are under the management of the Ministry of Health or other ministries.
- The Department of Health shall be the competent authority to issue operating licenses for local clinics that are under its management.
Legal basis: Article 45 of the LOMDT 2009 and Article 42 of Decree 109.
VII. TIMELINE:
Pursuant to point b Clause 1 Article 47 of the LOMDT 2009, an operating license shall be issued within 90 days from the receipt date of a valid application dossier.
Above is our analysis of the prevailing laws of Vietnam relating to the requirements and conditions on the application for an operating license of a medical clinic. In case of any further inquiries, please revert to us at [email protected] for more assistance. With our team of qualified lawyers and legal experts majoring in the practice areas of corporation and investment, ALB & Partners can facilitate investors with the following services:
- Consulting and drafting legal documents supporting the establishment of a foreign-invested medical clinic;
- Consulting on specific conditions for the issuance of an operating license for a medical clinic;Preparing documents and dossiers, and/or carrying out relevant legal procedures for setting up a medical clinic;
- Consulting other legal issues relating to the operation of a foreign-invested clinic in Vietnam, including but not limited to tax, labor, commercial transactions, and compliance risks…
Should Clients need legal assistance from ALB & Partners, feel free to contact us via email: [email protected].
