Conditions for foreign investors to establish a general clinic

Conditions for foreign investors to establish a general clinic

According to Vietnamese law, medical examination and treatment services are conditional business lines. So, for foreign investors who want to establish a general clinic, are there any additional conditions? What are the procedures for establishment? Let’s find out with Siglaw in this article!

 

Legal basis for establishing a general clinic for foreign investors

Vietnam’s commitments in international treaties (WTO, FTAs, AFAS);

Law No. 61/2020/QH14, Law on Investment ;

Law No. 59/2020/QH14, Law on Enterprise;

Law No. 40/2009/QH12, Law on Medical Examination and Treatment;

Decree 87/2011/ND-CP detailing the Law on Medical Examination and Treatment;

Decree 109/2016/ND-CP guiding the issuance of medical practice certificates and operating licenses for medical examination and treatment facilities;

Decree 155/2018/ND-CP amending and supplementing a number of regulations related to investment and business conditions under the state management of the Ministry of Health;

Decree 31/2021/ND-CP detailing and guiding the implementation of a number of articles of the Investment Law; Decree 01/2021/ND-CP on business registration;

 

Conditions for establishing a general clinic for foreign investors

1.1. According to Vietnam’s commitments in the WTO, the FTAs

There are no restrictions on general clinics, except for the regulation on the minimum investment capital of 2 million USD.

1.2. According to Vietnamese law:

According to Vietnamese law, to establish a general clinic, it is necessary to satisfy 3 conditions:

+) It is a medical examination and treatment facility that has been granted an operating license according to the provisions of law;

+) It must have sufficient clinical and paraclinical examination departments, human resources and necessary medical equipment to examine and detect health status according to health standards and health examination forms issued with documents guiding health examination according to the provisions of law.

+) It has a license to operate medical examination and treatment issued by the Department of Health of the province or city.

In addition, according to the provisions of Article 25 of the Decree amended by Decree 155/2018/ND-CP, the general clinic must also meet the conditions on facilities, scale, medical equipment and personnel.

 

First, regarding facilities:

• Have a fixed location (except for mobile medical examination and treatment);
• Ensure conditions on radiation safety and fire prevention and fighting according to the provisions of law;
• Must arrange a sterilization area to handle reusable medical instruments, except in cases where there are no instruments that need to be re-sterilized or there is a contract with another medical facility to sterilize instruments.
• Have an emergency room, a patient room, a specialized examination room and a minor surgery room (if minor surgery is performed). The examination rooms in the general clinic must have enough space to perform specialized techniques.

Second, regarding the scale of the general clinic:

• Have at least 02 of the 04 specialties: internal medicine, surgery, obstetrics, pediatrics;
• Have a paraclinical department (testing and diagnostic imaging).

Third,  regarding the medical equipment

• Have sufficient medical equipment suitable for the scope of professional activities of the facility;
• Particularly, occupational disease examination and treatment facilities must have at least a biochemical testing department;
• Health consultation clinics or health consultation rooms via information technology and telecommunications are not required to have medical equipment specified in points a and b of this clause, but must have sufficient information technology and telecommunications means and equipment suitable for the scope of registered activities.
• Have anti-shock medicine boxes and sufficient specialized emergency medicines.

Fourth, on personnel:

• Each medical examination and treatment facility must have a person responsible for technical expertise. The person responsible for technical expertise and the heads of specialized departments of the medical examination and treatment facility must meet the following conditions:
• Be a doctor with a practicing certificate with a scope of professional activities suitable for the scope of professional activities of the facility.
• In the case of a medical examination and treatment facility that includes multiple specialties, the practice certificate of the person responsible for technical expertise must have a scope of professional activities appropriate to at least one of the clinical specialties that the facility is registered to operate.
• For the following specialized clinics, the person responsible for technical expertise must also meet the conditions specified in Article 23a of Decree 155/2018/ND-CP;
• Have at least 36 months of medical examination and treatment practice experience after being granted a practice certificate or have at least 54 months of direct participation in medical examination and treatment. The assignment and appointment of the person responsible for technical expertise of the medical examination and treatment facility must be stated in writing;
• Be a full-time practitioner at the facility.
• In addition to the person responsible for technical expertise of the medical examination and treatment facility, other subjects working in the facility, if they perform medical examination and treatment, must have a practice certificate and may only perform medical examination and treatment within the scope of their assigned work. Based on the scope of professional activities, diplomas, certificates, training certificates and capacity of the practitioner, the person responsible for technical expertise of the medical examination and treatment facility shall assign practitioners to perform professional techniques in writing;
• In addition, there are regulations on qualifications and capacity for some positions such as: laboratory technician, X-ray bachelor, etc.
• The number of doctors who examine and treat patients on a regular basis must reach at least 50% of the total number of doctors who practice medical examination and treatment in the general clinic. The person in charge of specialized clinics and paraclinical departments (testing and diagnostic imaging) of the General Clinic must be a full-time employee at the clinic.

 

Forms of investment in general clinic services

• Direct investment: Establishing an economic organization with foreign investment capital;
• Indirect investment: Registering to contribute charter capital, buying shares, and capital contributions to a company operating general clinics in Vietnam;

 

Procedures for establishing a multidisciplinary clinic for foreign investors

Step 1: Apply for an Investment Registration Certificate (IRC)

Documents for requesting an Investment Registration Certificate:

• A written request to implement a security business investment project, including a commitment to bear all costs and risks if the project is not approved;
• Documents on the legal status of the foreign investor: ID card, passport, identity card for individual investors; copy of the Enterprise Registration Certificate or other equivalent document confirming the legal status for institutional investors with consular confirmation
• Documents proving the financial capacity of the foreign investor, including at least one of the following documents: financial statements of the last 2 years of the foreign investor; commitment to financial support from the parent company; commitment to financial support from a financial institution; guarantee of the financial capacity of the investor; Other documents proving the financial capacity of the foreign investor;
• The proposal for an investment project to provide general clinic services includes the following main contents: investor or form of investor selection, investment objectives, investment scale, investment capital and capital mobilization plan, location, duration, implementation progress, information on the current land use status at the project implementation location and proposed land use needs (if any), labor needs, proposed investment incentives, impacts, socio-economic efficiency of the project, preliminary assessment of environmental impacts (if any) in accordance with the provisions of the law on environmental protection.

 

In cases where the law on construction stipulates the preparation of a pre-feasibility study report, the investor may submit a pre-feasibility study report instead of the investment project proposal;

• In case the investment project for the business of general clinic services does not request the State to allocate land, lease land, or allow the change of land use purpose, a copy of the land use right papers or other documents determining the right to use the location to implement the investment project shall be submitted;
• Explanation of the technology used in the investment project for the business of general clinic services for projects subject to appraisal and consultation on technology according to the provisions of law on technology transfer;
• Other documents related to the investment project, requirements on conditions and capacity of the investor according to the provisions of law (if any).
• Number of dossiers: 01 set
• Processing time: The investment registration agency shall issue the Investment Registration Certificate to the foreign investor within 15 days from the date of receipt of valid dossiers.
• Issuing authority: Department of Planning and Investment of the province where the company intends to establish its headquarters

 

Step 2: Apply for an Enterprise Registration Certificate (ERC)

After being granted an Investment Registration Certificate, the investor shall carry out the procedure for applying for a business registration certificate for a multidisciplinary clinic service business by one of the following three methods:

• Register the business directly at the Business Registration Office;
• Register the business via postal service;
• Register the business via the electronic information network.

The dossier includes the following documents:

• Application for establishment of an FDI enterprise operating a multidisciplinary clinic;
• Company charter;
• List of members or shareholders of the company (if it is a limited liability company with two or more members or a joint stock company);
• Copies of legal documents of members, shareholders, and representatives (For individual investors: Copies of citizen identification cards, identity cards, passports, or other legal personal identification of founding members or shareholders; For investors that are economic organizations: Copies of the decision to establish the company, business registration certificate, or other equivalent documents of the organization; copies of valid identity cards or passports of the legal representative of the organization);
• Investment registration certificate
• Other necessary documents (if any);

Within 03 working days from the date of receipt of the dossier, the Business Registration Authority shall be responsible for reviewing the validity of the business registration dossier and granting the business registration; in case the dossier is invalid, the Business Registration Authority shall notify in writing the contents that need to be amended or supplemented to the business founder. In case of refusal to register the business, it shall notify in writing the business founder and state the reasons.

 

Issuing authority:

 

• At provincial level: Business Registration Office under the Department of Planning and Investment

 

The Business Registration Office can organize points to receive dossiers and return results under the Business Registration Office at different locations in the province;

 

• At district level: Finance – Planning Office under the District People’s Committee

 

Step 3: Procedures for applying for a license to operate a general clinic (According to Decree 109/2016/ND-CP)

Application for a license to operate a general clinic

• Application for a license to operate according to Form 01 of Appendix XI issued with this Decree;
• A valid copy of the decision to establish or a document with the name of the medical examination and treatment facility issued by a competent state agency for a state medical examination and treatment facility or a business registration certificate for a private medical examination and treatment facility or an investment certificate for a foreign-invested medical examination and treatment facility;
• A valid copy of the practice certificate of the person responsible for the technical expertise of the medical examination and treatment facility; the person in charge of the professional department of the medical examination and treatment facility;
• List of registered practitioners at medical examination and treatment facilities (including registration of practitioners and medical professionals at the facility but not required to be granted a practice certificate) according to the form prescribed in Appendix IV issued with this Decree;
• Declaration of facilities, medical equipment, organization and personnel of the medical examination and treatment facility according to Form 02 Appendix XI issued with this Decree;
• Documents proving that the medical examination and treatment facility meets the conditions on facilities, medical equipment, and personnel organization in accordance with the scope of professional activities of one of the organizational forms prescribed in Section 1 Chapter III of this Decree;
• The charter of organization and operation for state hospitals shall follow the form prescribed by the Minister of Health; for private hospitals, follow Form 03 Appendix XI issued with this Decree and the initial operation plan for the hospital;
• A valid copy of the patient transport contract for hospitals and maternity homes that do not have emergency transport vehicles outside the facility;
• A list of technical expertise of the medical examination and treatment facility proposed based on the list of technical expertise issued by the Minister of Health;
• For emergency service facilities and patient transport support facilities: A valid copy of the professional support contract with the hospital. In case of providing patient transport services abroad, a valid copy of the patient transport contract with the aviation service company is required.
• Submission method:
• Submit the application directly to the receiving agency
• Application sent by post

After receiving the application, the receiving agency sends the investor a Receipt of Application

• Authority: Department of Health
• Time limit:

+) In case the application is valid, the receiving agency must consider granting it within 45 days from the date recorded on the Receipt of Application

+) In case the application for a license to operate is not valid, the following shall be done:

Within 10 working days from the date recorded on the Receipt of Application, the receiving agency must issue a written notice to the facility requesting a sub-license to operate a general clinic to complete the application.

Upon receiving a written request to complete the dossier, the medical examination and treatment facility requesting to issue, re-issue, or adjust the operating license, or to change the person in charge of professional expertise for the medical examination and treatment facility must supplement or amend in accordance with the contents stated in the document and send it to the agency receiving the dossier;

After 10 working days from the date of receipt of the supplemented or amended dossier, if the agency receiving the dossier does not have a written request for amendment or supplementation, it must issue, re-issue, or adjust the operating license within the time specified in Point b of this Clause; if it does not issue, re-issue, or adjust, it must have a written response stating the reason;

After 60 days from the date the agency receiving the dossier has a written request, if the facility requesting to issue an operating license does not supplement or amend, or supplements or amends the dossier but does not meet the requirements, it must re-implement the procedure for requesting to issue, re-issue, or adjust the operating license.

 

For comprehensive free CONSULTATION ON ESTABLISHING A MULTI-SPECIALTY CLINIC FOR FOREIGN INVESTORS IN VIETNAM, please contact:

Siglaw Law Firm

Phone: (+84) 961 366 238

Email:

• vphn@siglaw.com.vn
• vphcm@siglaw.com.vn

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