Procedure for applying for a general clinics operating license

1. Dossier of application for a general clinic operating license 

• An application for an operation license is made according to Form 01 Appendix XI issued together with Decree 109/2016/ND-CP.

• A valid copy of the practice certificate of the person in charge of professional and technical expertise of the medical examination and treatment establishment; the person in charge of the specialized section of the medical examination and treatment establishment.

• Documents proving that the medical examination and treatment establishment satisfies the conditions on physical facilities, medical equipment, and personnel organization suitable to the scope of professional activities of one of the forms of organization specified in Clause 1 Section 1 Chapter III Decree 109/2016/ND-CP.

• A valid copy of the establishment decision or a document with the name of the medical examination and treatment establishment issued by a competent state agency, for state medical examination and treatment establishments, or the enterprise registration certificate, for with a private medical examination and treatment establishment or an investment certificate for a foreign-invested medical examination and treatment establishment.

• List of registered practitioners at medical examination and treatment establishments (including registration of practitioners and people working in the medical profession at the establishment but not subject to the issuance of practice certificates) according to the form prescribed in Clause 1 of Appendix IV issued together with Decree 109/2016/ND-CP.

• A declaration of physical facilities, medical equipment, organization and personnel of the medical examination and treatment facility according to Form 02, Appendix XI issued together with Decree 109/2016/ND-CP.

• The list of professional and technical expertise of the medical examination and treatment establishment is proposed on the basis of the list of professional and technical expertise promulgated by the Minister of Health.

2. Procedure for granting a general clinic operating license 

• Submit application at the reception room.

• Within 90 days from the date of receipt of a complete dossier, the Director of the Department of Health shall grant or adjust the operation license; if the operation license is not granted or adjusted, it must reply in writing and state the reasons therefore.

• Upon receiving a written request to complete the dossier, the medical examination and treatment establishment applying for an operation license must supplement or amend it according to the contents stated in the document and send it to the receiving agency. file. The date of receipt of the supplemented or modified dossier is stated on the application receipt. After 10 working days from the date of receipt of the supplement or modification dossier, if the dossier-receiving agency does not make a written request for amendment or supplementation, it must issue an operation license within the time limit specified in Points b and c, Clause 1, Article 47 of the Law on medical examination and treatment; if not granted, there must be a written reply clearly stating the reason.

3. Organizing the appraisal to grant the operation license for the general clinics

• The director of the provincial Department of Health shall establish an appraisal team to grant and adjust the operation license for medical examination and treatment establishments, except for the case specified in Clause 1 of this Article as follows:

• The representative of the leader of the provincial Department of Health or the representative of the standing unit of the appraisal delegation specified in Clause 3 of this Article shall act as the head of the delegation.

• The leading representative of the Medical Practice Management Division or the Medical Profession Department (for provincial Health Services that have not yet established a Practice Management Division) shall act as the deputy head of the delegation.

• Representative of the Medical Profession Department (for provincial Health Departments that have established a Practice Management Division).

• Representative of the Personnel and Organization Department (for the case of appraisal of state medical examination and treatment establishments).

• The representative of the hospital has a specialty suitable to the scope of professional activities for which the medical examination and treatment establishment applies for registration (if necessary).

• Other relevant stakeholders if necessary (representatives of health management agencies of ministries and branches for medical examination and treatment establishments affiliated to other ministries or branches).

• An expert from the Practice Management Division or the Medical Profession Department (for provincial Health Departments that have not yet established a Practice Management Division) shall act as the secretary of the appraisal team.

4. Fee for operation license of general clinics

• License appraisal fee: 5,700,000 VND.

• License fee: 350,000 VND.

5. Legal basis

• Decree 87/2011/ND-CP – Detailed guidance on the Law on medical examination and treatment.

• Decree 109/2016/ND-CP – Guiding the issuance of medical practice certificates and operation licenses for medical examination and treatment establishments.

• Circular 278/2016/TT-BTC – Rates of collection, payment, management and use of fees in the health sector.