PROCEDURES FOR ESTABLISHMENT OF SPECIALIZED CLINIC

With the rise of many new dangerous diseases, medical service is one of the business sector that is not just socially beneficial but also highly profitable for the investor. However, this is a conditional business sector. Therefore, the establishment and operation of a healthcare facility must oblige to the legal requirements and issued an operation license by the competent authority. In this article, LVI Law Firm shall provide the needed information related to the establishment of specialized clinics.

Requirements for the issuance of operation license to specialized clinics

1. Facilities requirements for specialized clinics

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.

• 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.

2. Medical equipment requirements for specialized clinics

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.

Have anti-shock first aid kits and sufficient specialized emergency drugs

3. Personnel requirements for specialized clinics

The chief physician must have a practicing certificate which is suitable to the practice scope of at least one of the registered clinical departments. Additionally, such individuals have provided medical examination and treatment for at least 36 months after being granted a practice certificate, or have directly participated in providing medical examination and treatment for at least 54 months and must work on a full-time basis at the health facility. The chief physician of the health facility must be assigned in writing to carry out the tasks.

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.

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.

Clinic of HIV/AIDS treatment: being a doctor of infectious disease speciality or a general practitioner with a certificate of training in HIV/AIDS treatment.

Clinic of dietetics: being a nutrition expert or a general practitioner with a certificate of training in dieting, or a preventive medicine doctor with a certificate of training in dieting or 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.

Clinic of cosmetic: Being a plastic surgeon or a Cosmetological doctor or a cosmetic surgeon.

Clinic of andrology: Being an adrological doctor or a general doctor with a certificate of training in andrology.

Other practitioners working in the specialized clinics must have practice certificates and shall only provide medical examination and treatment within the assigned practice scope.

Issuance authority of operation licenses to specialized clinics

Department of Health of the province where the clinic is headquartered.

Composition of applications for issuance of operation licenses to specialized clinics

The form No. 01 in Annex XI enclosed with Decree No. 109/2016/ND-CP;

A valid copy of the establishment decision or a document containing the name of the healthcare facility issued by a competent authority, applicable to state-owned healthcare facilities, or a certificate of enterprise registration, applicable to private healthcare facilities, or an investment certificate, applicable to foreign-invested healthcare facilities;

Valid copies of practice certificates of chief physicians of the healthcare facilities; persons taking charge of professional department of the healthcare facilty;

The form in Annex IV enclosed with Decree No. 109/2016/ND-CP;

The form No. 02 in Annex XI enclosed with Decree No. 109/2016/ND-CP;

Documents proving that the healthcare facility satisfies the requirements for facilities, medical equipment and organization suitable for the practice scope;

The Charter of organization and operation applicable to state-owned hospitals, or that applicable to private hospitals;

A professional and technical list proposed by the healthcare facility on the basis of the professional and technical list issued by the Minister of Health;

Procedures for issuance of operation licenses to specialized clinics

Step 1: The clinic sent the application for issuance of operation license to Department of Health and is given an application receipt note as accordingly to the law.

Step 2: Department of Health conducts the inspection of the application.

• If the application is satisfactory, the receiving authority shall consider the issuance of the operation license within 45 days from the date written on the receipt note. If the application is rejected, a written response containing explanation shall be sent.

• If the application is not satisfactory: Within 10 working days from the date written on the receipt note, Department of Health shall send a written notification to the applicant containing the request for completion. Such notification must specify the contents subject to supplementation and those subject to modification. After receiving the request for completion of the application, the chief physicians of the healthcare facility shall comply with the request and send the revised application to the receiving authority in the duration of 60 days.

After 10 working days from the day on which the revised application is received, the receiving authority which does not request modification or supplementation to the application shall issue operation license within the period of 45 days from the date written on the receipt note. Otherwise, written response containing explanation shall be sent.

Result of the procedure: A operation license of the specialized clinic.

If dear client still has problems about the procedures for the establishment of specialized clinics, please consider choosing LVI Law Firm, with its team of highly experienced Lawyers and legal experts in this major, to get the most immediate legal consultation and assistance.

With best regards!