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Legal situation: I’m an investor who comes from The United States of America (USA). I'm planning to establish a polyclinics for commercial purposes. Could you please advise me on what conditions must be met in order to set up a polyclinics in Vietnam? Thank you, Lawyer.
Response:
Thank you for sending your question to FDVN Law Firm. In response to your request, after reviewing the relevant legal provisions, we would like to provide the following analysis:
Firstly, for foreign investors to open a polyclinics, they must obtain an Investment Registration Certificate in accordance with clause (c) of subparagraph 1 of Article 22 of the Investment Law 2020 and be issued a Business Registration Certificate to establish a company and operate legally in Vietnam.
To obtain a new License for a polyclinics, investors must ensure that they meet the conditions specified in Articles 40 and 42 of Decree No. 96/2023/ND-CP, specifically as follows:
Regarding the scale:
It must have at least three specialties which include at least two of the following: internal medicine, surgery, obstetrics and pediatrics; establish subclinical departments (medical laboratory and medical imaging); and have emergency room, minor surgery room (if minor surgery operations are performed) and patient stay room;
In case a polyclinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scope of professional activities may include professional activities of such form of organization of health facility.
Regarding material facilities:
The health facility must have a fixed location which must meet regulations of law on bearing safety, fire prevention and fighting, bacterial contamination control, environmental protection, and radiation safety (if any); and must be equipped with electrical and water systems capable of serving its operation;
It must have a signboard, patient flowchart and wayfinding signs to professional and administrative wards, departments and sections;
If the health facility establishes a venue outside its precinct, this venue must be also required to meet the specific conditions for the relevant form of organization as prescribed in Article 39 of this Decree.
Medical examination rooms of a polyclinic must meet the following minimum area requirements:
- The minimum area of the emergency room is 12 m2;
- The patient stay room has a minimum area of 15 m2, and has at least 02 hospital beds. If there are at least 03 hospital beds in the patient stay room, the minimum area of at least 05 m2 per hospital bed must be ensured;
- The minimum area of each specialty-specific medical examination room is 10 m2;
If techniques and minor surgery operations are performed, in addition to specialty-specific medical examination rooms, a technical and minor surgery room with a minimum area of at least 10 m2 must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m2.
A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the polyclinic has entered into a contract for sterilization of medical devices with another health facility.
If traditional drugs are prepared or made up, standards for preparation of traditional drugs adopted by the Minister of Health of Vietnam must be met.
The polyclinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.
Regarding personnel:
The health facility must employ sufficient medical practitioners according to its scale and list of professional techniques, and ensure the medical practitioner ratio set by the Minister of Health of Vietnam (including medical practitioners who have been issued with practicing licenses by licensing authorities in people’s armed forces, stop working in people’s armed forces but still use their issued practicing licenses);
a) For the person in charge of professional practices of the health facility:
The person in charge of professional practices of the health facility must be its full-time medical practitioner whose scope of practice is appropriate to its scope of professional activities, and who has practiced within such scope of professional activities for at least 36 months, except a medical practitioner who is a herbalist, folk remedy holder or folk therapy holder.
In case the health facility has different specialties, the scope of practice on the practicing license of its person in charge of professional practices must be appropriate to one of its registered specialties;
The manager of a professional department or unit of the health facility must possess a practicing license appropriate to his/her in-charge specialty and must be its full-time medical practitioner;
Medical practitioners must be vested with tasks appropriate to their scope of practice approved by competent authorities;
Medical technicians whose scope of practice involves medical laboratory and who possess bachelor’s degrees may read and sign test reports. In case the health facility does not have any medical practitioner who is granted a practicing license for the title of doctor specializing in medical laboratory technology or medical technician possessing bachelor’s degree whose scope of practice involves medical laboratory, the doctor giving prescription for testing shall read and sign such test report.
Medical technicians whose scope of practice involves medical imaging and who possess bachelor’s degrees may read and describe diagnostic images. In case the health facility does not have any medical practitioner who is granted a practicing license for the title of doctor specializing in medical imaging technique or medical technician possessing bachelor’s degree whose scope of practice involves medical laboratory, the doctor giving prescription for medical imaging technique shall read and sign such medical imaging report.
b) For other workers in the polyclinics:
Other persons engaging in medical examination and treatment without holding practicing licenses as prescribed in point d clause 2 Article 19 of the Law on Medical Examination and Treatment (such as medical physics engineers, radiotherapy engineers, biotechnology engineers, biotechnology bachelors and other persons (hereinafter referred to as “employees”) may perform professional activities as assigned by the health facility’s person in charge of professional practices. This assignment must be appropriate to the professional qualification and capacity of the assigned employee.
If a medical practitioner who is a lecturer of a training institution in the healthcare sector is working at a health facility that acts as an instructing facility accepting medical interns from that training institution, he/she may hold the position of manager of a professional department, department or ward of that health facility.
Other conditions:
It must have sufficient clinical and subclinical departments, personnel and medical devices necessary for examination, screening and detection of health conditions according to health standards and templates of health check forms enclosed with guiding documents on health checks;
Data on health check forms for drivers must be connected with the healthcare management information system or national healthcare database or data receipt portal of the health insurance assessment information system.
Above are the legal regulations and necessary conditions for foreign investors to establish and operate a polyclinics in Vietnam. We hope that this advisory provides you with a comprehensive overview and helps you adequately prepare all the essential elements required to implement your investment plan. Should you need further information or detailed support, please do not hesitate to contact FDVN Law Firm. We are always ready to assist you with all your legal matters.
According to Tuan Thi - FDVN Law Firm
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