CONDITIONS FOR ESTABLISHING POLYCLINICS FOR FOREIGN INVESTORS

CONDITIONS FOR ESTABLISHING POLYCLINICS FOR FOREIGN INVESTORS

According to the provisions of Vietnamese law, the provision of medical examination and treatment services belongs to conditional business lines. So for foreign investors who want to establish a polyclinic, are there any additional conditions, what is the order of establishment procedures? Let’s find out with Siglaw in this below article!

Legal basis:

• Vietnam’s commitments in international treaties (WTO, FTAs, AFAS);
• Law No. 61/2020/QH14, Law on Investment;
• Law No. 59/2020/QH14, Law on enterprises;
• 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 operation licenses for medical examination and treatment establishments;
• Decree 155/2018/ND-CP amending and supplementing some regulations related to business investment conditions under state management of the Ministry of Health;
• Decree 31/2021/ND-CP detailing and guiding the implementation of some articles of the Investment Law;
• Decree 01/2021/ND-CP on business registration;

Investment conditions for foreign investors in the field of polyclinic business

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

For polyclinics, there are no restrictions, except for a minimum investment of 2 million USD.

1.2. According to Vietnamese law:

According to the provisions of Vietnamese law, to establish a polyclinic, it is necessary to satisfy 3 conditions:

+) Being a medical examination and treatment establishment that has been granted operation licenses under law;

+) There must be sufficient clinical, and subclinical examination departments, human resources, and medical equipment necessary to examine and detect health conditions according to health standards and health examination slip forms issued together with documents guiding health examination under law.

+) Having a license for medical examination and treatment activities issued by provincial/municipal Health Departments.

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

Firstly, in terms of facilities: 

• Having a fixed location (except for the case of organizing mobile medical examination and treatment);
• Ensuring conditions on radiation safety and fire prevention and fighting under the provisions of law;
• Arranging a sterilization area for the handling of reusable medical instruments, except in cases where there are no instruments to be re-sterilized or there is a contract with another medical facility to sterilize instruments.
• Having an emergency room, patient storage room, specialist clinic, and minor surgery room (if minor surgery is performed). Clinics in polyclinics must have a sufficient area for the implementation of specialized techniques.

  Secondly, about the size of polyclinics:

• Having at least 02 out of 04 specialties of internal medicine, surgery, obstetrics, and pediatrics;
• Having a subclinical department (laboratory and diagnostic imaging).

Third, about medical equipment

• Having sufficient medical equipment suitable to the scope of professional activities of the establishment;
• Particularly, occupational disease examination and treatment establishments must have at least biochemical testing departments;
• Having sufficient information technology, telecommunications and equipment suitable to the scope of registered activities.
• Having a shock medicine box and enough specialized emergency medicine.

Fourth, on personnel:

• Each medical examination and treatment establishment must have a person responsible for technical expertise. Persons in charge of technical expertise and heads of specialized departments of medical examination and treatment establishments must satisfy the following conditions:
• Being a doctor with a practicing certificate with a scope of professional activities suitable to the scope of professional activities of the establishment.
• In case a medical examination and treatment establishment consists of many specialties, the practicing certificate of the person responsible for technical expertise must have the scope of professional activities suitable to at least one of the clinical specialties in which the establishment is registered.
• For the following specialized clinics, the person responsible for technical expertise must also meet the conditions specified in Article 23 of Decree 155/2018/ND-CP;
• Having a medical examination and treatment practice period of at least 36 months after being granted a practicing certificate or have a direct participation in medical examination and treatment for at least 54 months. The assignment and appointment of persons responsible for professional and technical expertise of medical examination and treatment establishments must be expressed in writing;
• Being an organic practitioner at the facility.
• In addition to persons in charge of professional and technical expertise of medical examination and treatment establishments, other persons working in establishments, if performing medical examination and treatment, must have practicing certificates and may only perform medical examination and treatment within the scope of assigned work. Based on the scope of professional activities, diplomas, certificates, training certificates and competence of practitioners, persons in charge of professional and technical expertise of medical examination and treatment establishments shall assign practitioners to perform professional techniques in writing;
• There are also regulations on qualifications and competencies for some positions such as laboratory technician, bachelor of X-ray, ..
• The number of doctors conducting medical examination and treatment must reach at least 50% of the total number of doctors practicing medical examination and treatment of general clinics. The person in charge of specialized clinics and subclinical departments (laboratory and imaging) of the Polyclinic must be a permanent worker at the clinic.

Forms of investment in the business of polyclinic services

• Direct investment: Establish foreign-invested economic organizations;
• Indirect investment: register capital contribution, purchase of shares, capital contribution to a polyclinic business company in Vietnam;

Procedures for establishment of a polyclinic service company

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

Dossier of  application for an Investment Registration Certificate:

• A written request for implementation of a protective business investment project, including a commitment to bear all costs and risks if the project is not approved;
• Documents on the legal status of foreign investors: ID card, passport, identity card for individual investors; a certificed copy of the Certificate of Incorporation or other equivalent document confirming the legal status of the investor being an organization certified by the consular
• Documents proving the foreign investor’s financial capacity include at least one of the following documents: financial statements of the last 02 years of the foreign investor; commitment to financial support of the parent company; commitment to financial support of the financial institution; guarantee on the financial capacity of the investor; other documents proving the financial capacity of the foreign investor;
•  A proposal for an investment project for provision of polyclinic services includes the following principal contents: investor or form of investor selection, investment objectives, investment scale, investment capital and capital mobilization plan, location, duration, implementation schedule, etc  information on the current status of land use at the project site and proposal of land use demand (if any), labor demand, proposal for investment incentives, impacts, socio-economic efficiency of the project, preliminary environmental impact assessment (if any) in accordance with the law on environmental protection.

Where the law on construction provides for the preparation of a pre-feasibility study report, the investor may submit the pre-feasibility study report instead of the investment project proposal;

• In case the investment project providing polyclinic services does not request the State to allocate land, lease land, permit change of land use purpose, submit a copy of the land use right document or other document determining the right to use the location for the implementation of the investment project;
• Contents of explanation of technologies used in investment projects on the provision of polyclinic services for projects subject to appraisal and collection of opinions on technologies under the law on technology transfer;
• Other documents related to the investment project, requirements on conditions and capacity of the investor as prescribed by law (if any).

• Number of documents: 01 set

• Time limit for settlement: The investment registration agency shall issue the Investment Registration Certificate to the foreign investor within 15 days from the date of receipt of a valid dossier.
• Competence to grant: Department of Planning and Investment of the province where the company intends to establish its headquarters

Step 2: Apply for an Enterprise Registration Certificate

After being granted the Investment Registration Certificate, the investor shall carry out the procedures for applying for the Enterprise Registration providing polyclinic services by one of the following three methods:

• Enterprise registration directly at the Enterprise Registration Office;
• Enterprise registration via postal service;
• Enterprise registration via electronic information network.

The dossier includes the following documents:

• An application for establishment of a security service enterprise;
• The company’s 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);
• Certified copies of legal papers of members, shareholders, representatives (For individual investors: Certified copies of citizen identity cards, identity cards, passports or other lawful personal identification of founding members or shareholders; For investors being economic organizations:  A copy of the company’s establishment decision, business registration certificate or other equivalent document of the organization; copy of valid identity card or passport of the legal representative of the organization);
• Investment registration certificate
• Other required documents (if any);

Within 03 working days  from the date of receipt of the dossier, the business registration agency shall consider the validity of the enterprise registration dossier and grant business registration; in case the application is invalid, the business registration agency must notify in writing the contents to be amended,  additions for business founders. In case of refusal to register an enterprise, it must notify in writing the enterprise founder by clearly stating the reason.

Authority granted:

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

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

• At the district level: Finance and Planning Department under the District People’s Committee

Step 3: Procedures for applying for operation license for polyclinics (According to Decree 109/2016/ND-CP)

Dossier of  application for operation license for polyclinic 

• An application for an operation license according to Form 01 of Appendix XI promulgated together with this Decree;

• A valid copy of the establishment decision or a document bearing the name of the medical examination and treatment establishment of a competent state agency for the State’s medical examination and treatment establishment or an enterprise registration certificate for a private medical examination and treatment establishment or an investment certificate for a medical examination establishment,  foreign-invested medical treatment;

• A valid copy of the practicing certificate of the person responsible for professional and technical expertise of the medical examination and treatment establishment; persons in charge of specialized departments of medical examination and treatment establishments;

• List of registration of practitioners at medical examination and treatment establishments (including registration of practitioners and persons working in medical professions at establishments but not subject to issuance of practice certificates) according to the form specified in Appendix IV promulgated together with this Decree;

• A declaration of medical facilities, equipment, organizations and personnel of medical examination and treatment establishments according to Form 02 of Appendix XI promulgated together with this Decree;

• Documents proving that medical examination and treatment establishments satisfy conditions on material foundations, medical equipment and personnel organization in conformity with the scope of professional activities of one of the organizational forms specified in Section 1, Chapter III of this Decree;

• The charter on organization and operation of state hospitals shall comply with the form prescribed by the Minister of Health; for private hospitals complying with Form 03 of Appendix XI promulgated together with this Decree and the initial operation plan for hospitals;

• A valid copy of the contract for the transport of patients for hospitals or maternity homes that do not have emergency transport facilities outside the facility;

• The list of technical expertise of medical examination and treatment establishments shall be proposed on the basis of the list of technical expertise promulgated by the Minister of Health;

• For emergency service establishments, assistance in transporting patients: A valid copy of the professional support contract with the hospital. In the case of providing services for transporting patients abroad, a valid copy of the contract of carriage of the patient with the airline service company is required.

• Delivery method:

• Apply directly at the receiving agency
• Mailed documents

After receiving the dossier, the receiving agency shall send the investor a receipt form

• Jurisdiction: Department of Health
• Term:

+) In case the application is valid, the dossier-receiving agency must consider issuing it within 45 days from the date stated on the dossier receipt form

+) In case the application for an operation license is not valid, the following shall be done:

Within 10 working days from the date stated on the dossier  receipt form, the dossier-receiving agency must notify in writing the establishment applying for an operation license to complete the dossier. 

Upon receipt of a written request for completion of a dossier, a medical examination and treatment establishment requesting for issuance, re-issuance, adjustment of operation licenses or change of persons having professional responsibility for medical examination and treatment establishments must supplement or amend them under the contents stated in the documents and send them to the dossier-receiving agency;

After 10 working days from the date of receipt of the  supplementary or amended dossier, if the dossier-receiving agency does not make a written request for amendment or supplementation, it must grant, re-grant or modify the operation license within the time specified at Point b of this Clause; if not granted,  reissuance or adjustment, a written reply clearly stating the reasons therefor must be given;

After 60 days from the date on which the dossier-receiving agency makes a written request, but the establishment applying for an operation license fails to supplement, amend, or supplement or amend the dossier but fails to meet the requirements, it must repeat from the beginning of the application procedure,  reissuance and modification of operation licenses.

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Siglaw Law Firm

Phone: (+84) 961 366 238

Email:

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

Headquarters: Floor 12A Sao Mai Building, 19 Le Van Luong Street, Nhan Chinh Ward, Thanh Xuan District, Hanoi City.

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