Requirements for issuance of the operating licenses to the hospitals in Vietnam

Requirements for issuance of the operating licenses to the hospitals in Vietnam (Internet image)

Requirements for issuance of the operating licenses to the hospitals in Vietnam

Pursuant to the provisions of Clause 5, Article 11 of Decree 155/2018/ND-CP amending Article 23 of Decree 109/2016/ND-CP, requirements for issuance of the operating licenses to the hospitals include:

Aside from the requirements specified in Article 23a of Decree 109/2016/ND-CP amended by Decree 155/2018/ND-CP, the hospitals must also satisfy the following requirements:

- Scale of hospitals:

+ A general hospital must have at least 30 patient beds.

+ A specialized or traditional hospital must have at least 20 patient beds. Particularly, an ophthalmologic or a psychiatric hospital must have at least 10 patient beds.

- Facilities:

Aside from the requirements specified in Article 23a of Decree 155/2018/ND-CP and depends on the scale of the hospital, a specialized or a general hospital must be designed and built in accordance with the following requirements:

+ Departments, rooms and hallways must be arranged conveniently for technique expertise under the interconnected and self-contained complex model within the hospital premises.

+ As for a general and a specialized hospital, there must be a minimum construction floor area of 50 m2 per patient bed; the hospital façade must be at least 10m.

+ There must be a stand-by generator.

+ Requirements for medical waste treatment must be satisfied according to the regulations on environment.

- Medical equipment: There must be sufficient emergency vehicles for transporting patients in and out of the hospital. If there are no emergency vehicles providing out-of-hospital treatment, a contract must be signed with a health facility which has been granted an operating license and its practice scope includes the provision of emergency transport services.

- Organization:

+ Departments:

++ There must be at least 02 of 04 departments of internal medicine, surgery, obstetrics and pediatrics, applicable to general hospitals, or an appropriate clinical department, applicable to specialized hospital.

++ The medical examination department shall have a place for patient reception, emergency and patient stay rooms, consulting rooms and minor surgery rooms (if any minor surgery is carried out).

++ The paraclinical department shall have at least one unit for testing and one unit for image diagnostic. Any ophthalmologic hospital having no image diagnostic unit must have a contract concluded with a healthcare facility having an operating license and with an image diagnostic unit.

++ Pharmaceutical department.

++ Other specialized departments and sections must be suitable to the scale, functions and tasks of the hospital.

+ There must be departments of general planning, organization and personnel, quality control, convalescence, finance and accounting and other necessary departments.

- Personnel:

+ The number of full-time (tenured) practitioners in each department must account for at least 50% of the total number of practitioners in such department.

+ The deans of specialized departments of the hospital must have practice certificates which are suitable to such departments and must be the full-time practitioners at the hospital.

+ Deans of other departments who are not granted the practice certificates must have bachelor degrees in the specialities suitable to the assigned tasks. Also, they must be full-time practitioners at the hospital.

 Authority to issue operating licenses for hospitals in Vietnam

Pursuant to Article 51 of the Law on Medical Examination and Treatment 2023 (effective as of January 1, 2024) stipulating the authority to issue, re-issue, modify or revise operating licenses; suspend operation; revoke or withdraw operating licenses for hospital in Vietnam:

- The Ministry of Health shall be empowered to issue, re-issue, modify or revise operating licenses; suspend operation; revoke or withdraw operating licenses of medical establishments under its control; suspend operation of other medical establishments nationwide.

- The Ministry of National Defence shall be empowered to issue, re-issue, modify or revise operating licenses; suspend operation; revoke or withdraw operating licenses of medical establishments under its jurisdiction.

- The Ministry of Public Security shall be empowered to issue, re-issue, modify or revise operating licenses; suspend operation; revoke or withdraw operating licenses of medical establishments under its jurisdiction.

- Health agencies under the People's Committees of provinces shall be empowered to issue, re-issue, modify or revise or revoke operating licenses of medical establishments at local areas falling within their remit, unless otherwise prescribed in clause 1, 2 and 3 of Article 51 of the Law on Medical Examination and Treatment 2023; suspend operation of medical establishments operating in local areas under their management.

Nguyen Pham Nhut Tan

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