Opening an Obstetrics Clinic in Vietnam

Obstetrics Clinic in Vietnam is becoming increasingly essential as the number of individuals facing reproductive health issues rises. Concurrently, there is a growing emphasis on the importance of pre- and post-natal health check-ups, which has led to an increased demand for expanding the scale and number of obstetrics clinics. Consequently, it is important to understand the necessary documents, procedures, and requirements for opening an obstetrics clinic. In the article below, Viet An Law advise on the procedures for opening an obstetrics clinic in Vienam through the article below.

What is an obstetrics clinic in Vietnam?

According to the provisions of the Law on Medical Examination and Treatment 2023 guided by Decree 96/2023/ND-CP detailing several articles of the Law on Medical Examination and Treatment:

Obstetrics clinic is a type of clinic that belongs to the form of specialized clinic organization. Accordingly, obstetrics clinics must have staff with degrees related to obstetrics.

Clinic service business in particular or medical examination and treatment in general is a conditional business line under the specialized regulation of the Ministry of Health, accordingly, the private establishment must meet the conditions to apply for a license to operate a clinic.

Conditions for establishment and operation of obstetrics clinics

To establish an obstetrics clinic, foreign investors, in addition to meeting the same licensing conditions as domestic investors, must also satisfy the market entry conditions according to WTO commitments, specifically, they must meet the minimum investment capital requirement of 200,000 USD to be granted an Investment Registration Certificate.

According to Articles 40 and 43 of Decree 96/2023/ND-CP, obstetric clinics are granted an operating license when they fully meet clinic facilities, equipment, and staff conditions. Specifically:

Conditions of clinic facilities

Obstetrics clinic needs:

Conditions of equipment at the clinic

At the clinic, there must be adequate medical equipment suitable for the scope of professional activities of the obstetrics clinic; equipped with anaphylaxis first aid kits and specialized emergency drugs suitable for obstetrics.

Conditions for human resources working at the clinic

• Have enough practitioners according to the scale, technical list and achieve the ratio of practitioners according to the regulations issued by the Minister of Health;
• The person in charge of obstetrics must be a full-time practitioner of the facility and have a scope of practice appropriate to the facility’s professional activities, with at least 36 months of practice in that field;
• Practitioners must be assigned work within the scope of practice approved by the competent authority;

Other subjects participating in the process of medical examination and treatment but not required to be granted a practice license as prescribed in Point d, Clause 2, Article 19 of the Law on Medical Examination and Treatment are allowed to perform professional activities under the assignment of the person responsible for professional and technical expertise and the assignment must be consistent with the professional qualifications and capabilities of that person.

Note: The assignment and appointment of the person responsible for technical expertise of the clinic must be shown in writing.

Procedures for opening an obstetrics clinic in Vietnam

According to current regulations, for private medical examination and treatment facilities operating for profit, to be granted a license to operate in Vietnam, the licensing application requires the legality of the investment capital source through the following procedures:

In the first phase, investors conduct establishment process as the same as the other normal business. It is included the process for obtain ERC and IRC in Vietnam. You can refer this article for further information. After that, before operation officially, clinic must obtain business license below.

Application for license to operate obstetrics clinic

Pursuant to Article 60 of Decree 96/2023/ND-CP, to apply for a license to operate an obstetrics clinic, individuals and organizations (including foreign-invested companies) need to prepare a dossier including the following documents:

• Application for operating license according to Form 02, Appendix II issued with Decree 96/2023/ND-CP;
• A valid copy of the enterprise registration certificate for private obstetrics clinics or the investment certificate for obstetrics clinics with foreign investment or the decision to establish an obstetrics clinic;
• Valid copies of practice licenses and certificates of practice experience according to Form 11, Appendix I issued with Decree 96/2023/ND-CP of the person responsible for technical expertise and the person in charge of the professional department of the obstetrics clinic.
• Declaration of facilities, list of medical equipment, list of personnel meeting the conditions for granting operating licenses corresponding to each form of organization according to Form 08 Appendix II issued with Decree 96/2023/ND-CP and documents proving and confirming such declarations;
• The list clearly states the full name and practice license number of each practitioner registered to practice at the facility;
• The list of technical specialties of the obstetrics clinic is proposed based on the list of technical specialties issued by the Minister of Health;
• Power of Attorney for Viet An Law to carry out procedures.

Procedures for applying for a license to operate an obstetrics clinic

Pursuant to Article 61 of Decree 96/2023/ND-CP, to open an obstetrics clinic, individuals and organizations (including foreign-invested companies) must go through the following steps:

Step 1: Submit 01 set of application documents for a license to operate an obstetrics clinic and pay the prescribed fee to the Department of Health where the medical examination and treatment facility is located;

Step 2: The Department of Health receives and sends a receipt of the application according to Form 02 Appendix I issued with Decree 96/2023/ND-CP to the applicant;

Step 3: Review the validity of the application

• In case the dossier is valid: the agency receiving the license to operate shall organize an assessment of the operating conditions and the list of technical implementation at the requesting facility, and at the same time make a record of the assessment within 60 days from the date stated on the dossier receipt.
• In case the application is invalid: within 10 working days from the date stated on the application receipt, the receiving agency must send a written notice to the facility requesting the operating license to complete the application. The written notice must specify which documents need to be supplemented and which content needs to be revised.

Step 4: Assessment at obstetrics clinic

• The Department of Health shall make a record of assessment within 60 days from the date recorded on the application receipt;
• In case there is no request for amendment or supplementation, issue a decision approving the list of techniques performed at the obstetrics clinic within 10 working days from the date of issuance of the appraisal record; In case of amendment or supplementation, the request must be issued within 10 days from the date recorded on the dossier receipt and the amended contents must be clearly stated in the content of the appraisal record.

Step 5: Granting a license to operate a clinic

Within 10 working days from the date of completion of the appraisal procedure (receiving the written notice and documents proving the completion of the remediation and repair of the requesting facility), the Department of Health shall conduct an actual inspection of the remediation and repair of the requesting facility if necessary or issue an operating license. In case of not issuing an operating license, a written response must be provided stating the reasons.

Step 6: Publish obstetrics clinic information

Within 05 working days from the date of issuance of the operating license, the Department of Health shall issue the operating license and publish it on its electronic information portal and on the Information System on management of medical examination and treatment activities.

Regulations on personal practice licenses for an obstetrics clinic in Vietnam

Regulations on the establishment of medical examination and treatment facilities are accompanied by conditions on personnel when establishing. Accordingly, to be allowed to practice obstetrics at clinics, the minimum required personnel must meet the following conditions:

• Have a valid practice license;
• Registered to practice, except in cases where registration to practice is not required as prescribed in Clause 3, Article 36 of the Law on Medical Examination and Treatment (for example, in the case of humanitarian rescue);
• Meet the requirement of using Vietnamese or the same language as the patient in medical examination and treatment;
• Have good health to practice according to regulations of the Minister of Health;
• Not in a case of being banned from practicing medicine, such as being in the process of serving a sentence.

In the case of foreigners and Vietnamese people residing abroad who have a practice license issued by a competent foreign agency or organization, they are allowed to provide humanitarian medical examination and treatment in batches, cooperate in medical training with practice of medical examination and treatment, or transfer professional techniques in medical examination and treatment according to the provisions of this Law without having to meet the above conditions on license and practice registration.

For support and advice on the conditions and procedures for opening an obstetrics clinic in Vietnam, please contact Viet An Law Firm for the best support.

Updated: 8/2024