What are the requirements for issuance of the operating licenses to the hospitals in Vietnam? - Pham Gia (HCMC)
Requirements for issuance of the operating licenses to the hospitals in Vietnam (Internet image)
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.
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.
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