What are the general requirements for issuance of operating licenses to healthcare facilities in Vietnam?
What are the general requirements for issuance of operating licenses to healthcare facilities in Vietnam?
Pursuant to Article 23a of Decree 109/2016/ND-CP (supplemented by Clause 4, Article 11 of Decree 155/2018/ND-CP) regulating general requirements for issuance of operating licenses to healthcare facilities are as follows:
Facility requirements:
- The healthcare facility has a fixed location (unless it is a mobile healthcare clinic).
- Radiation safety and fire safety are ensured in accordance with regulations of law.
- There is a separated area for sterilizing reusable medical instruments, unless there are no reusable instruments or the healthcare facility has a contract with another healthcare facility for sterilization of reusable instruments.
Medical equipment:
- Sufficient medical equipment must be provided and be suitable to the practice scope of the health facility.
- An occupational health service provider must have at least a Biochemistry Laboratory Department.
- Clinic providing healthcare consultancy or clinic providing healthcare consultancy by using information technology and telecommunications is not required to have the medical equipment specified in points a and b of this Clause. However, it must have sufficient information technology and telecommunications which are suitable to the registered practice scope.
Health facilities must satisfy the following requirements:
- Be the health facilities which are granted operating licenses according to the law.
- Have clinical and paraclinical departments, as well as sufficient personnel and equipment used for providing medical examination and detecting the health conditions of patients based on the health standards and medical forms which are enclosed with the documented guidelines on medical examination.
What are the general requirements for issuance of operating licenses to healthcare facilities in Vietnam?
What are the requirements for issuance of operating licenses to general medicine clinic in Vietnam?
Pursuant to Article 26 of Decree 109/2016/ND-CP (amended by Clause 8, Article 11 of Decree 155/2018/ND-CP) stipulates as follows:
Requirements for issuance of operating licenses to specialized clinics
Aside from the requirements specified in Article 23a hereof and except those applied to the chief physicians, the specialized clinics must also satisfy the following requirements:
1. Facilities:
a. If any operation is conducted, including implanting operation, acupuncture, massage or acupressure, the operation room must be located in a separate area. The area of the operation room must be sufficient for performing specialized techniques.
b. If the specialized clinic conducts both upper and lower gastro-endoscopic techniques, it must have 02 separate rooms.
c. There must be a biochemistry department for diagnosing and treating occupational diseases.
2. Medical equipment: Have anti-shock first aid kits and sufficient specialized emergency drugs
3. Personnel:
a) Any chief physician of a specialized clinic shall satisfy the following conditions:
- Being a doctor with a practice certificate suitable for at least one of the specialities registered by the clinic.
- Having worked as a healthcare practitioner in such speciality for at least 54 months.
Any chief physician of the following specialized clinics shall satisfy the corresponding conditions as follows:
+ Clinic of rehabilitation: being a doctor with a practice certificate relevant to physical therapy or rehabilitation;
+ Clinics 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;
+ Clinics of HIV/AIDS treatment: being a doctor of infectious disease speciality or a general practitioner with a certificate of training in HIV/AIDS treatment;
+ Clinics of dietetics: being a nutrition expert or a general practitioner with a certificate of training in dieting;
+ Clinics of cosmetic: being a plastic surgeon or an cosmetological doctors;
+ Clinics of andrology: being an andrological doctor or a general practitioner with a certificate of training in andrology.
b) If wishing to provide healthcare, persons other than the chief physicians of a specialized clinic working in the specialized clinic must have a practice certificate and be assigned in accordance with the practice scope specified in such practice certificate.
Accordingly, in addition to meeting the general requirements for issuance of operating licenses to healthcare facilities, specialized clinics of internal medicine must also meet the following conditions:
Facilities:
- If any operation is conducted, including implanting operation, acupuncture, massage or acupressure, the operation room must be located in a separate area. The area of the operation room must be sufficient for performing specialized techniques.
- If the specialized clinic conducts both upper and lower gastro-endoscopic techniques, it must have 02 separate rooms.
- There must be a biochemistry department for diagnosing and treating occupational diseases.
Medical equipment: Have anti-shock first aid kits and sufficient specialized emergency drugs
- Personnel:
Any chief physician of a specialized clinic shall satisfy the following conditions:
- Being a doctor with a practice certificate suitable for at least one of the specialities registered by the clinic.
- Having worked as a healthcare practitioner in such speciality for at least 54 months.
Any chief physician of the following specialized clinics shall satisfy the corresponding conditions as follows:
+ Clinic of rehabilitation: being a doctor with a practice certificate relevant to physical therapy or rehabilitation;
+ Clinics 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;
+ Clinics of HIV/AIDS treatment: being a doctor of infectious disease speciality or a general practitioner with a certificate of training in HIV/AIDS treatment;
+ Clinics of dietetics: being a nutrition expert or a general practitioner with a certificate of training in dieting;
+ Clinics of cosmetic: being a plastic surgeon or an cosmetological doctors;
+ Clinics of andrology: being an andrological doctor or a general practitioner with a certificate of training in andrology.
If wishing to provide healthcare, persons other than the chief physicians of a specialized clinic working in the specialized clinic must have a practice certificate and be assigned in accordance with the practice scope specified in such practice certificate.
Is a general medicine clinic a form of organization of health facilities in Vietnam?
Pursuant to Point a, Clause 4, Article 22 of Decree 109/2016/ND-CP amended by Clause 3, Article 11 of Decree 155/2018/ND-CP stipulates as follows:
Forms of organization of health facilities
The health facilities must be established in accordance with the law and must conform to one of the following forms of organization:
...
4. Specialized clinic, including:
a. General medicine clinic.
Accordingly, general medicine clinic is a form of organization of health facilities. Therefore, the conditions for granting operating licenses to internal medicine clinics will also be the same as those for granting operating licenses to medical examination and treatment facilities.
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