Hello Lawyer,
Currently, I want to establish a business in the field of cosmetics that includes tattooing, spraying, and embroidering on the skin. Could you please advise me on the business conditions for offering cosmetic services such as tattooing, spraying, and skin embroidery using injectable anesthetics? Thank you very much.
FDVN’s Opinion:
Thank you for submitting your question to FDVN Law Firm ("FDVN"). In response to your consultation request, after researching relevant legal regulations, FDVN would like to present our opinion as follows:
Conditions for operating a cosmetic service business of tattooing, spraying and skin embroidery using injectable anesthetics
According to Point b, Clause 12, Article 40 of Decree 96/2023/ND-CP: “A health facility that provides the following cosmetic services or uses products with pharmacological effects must be a hospital, polyclinic or specialty clinic:”
b) Tattooing, spraying, and skin embroidery using injectable anesthetics.”
Accordingly, if you wish to operate a business providing services of cosmetic tattooing, spraying, and skin embroidery using injectable anesthetics, you must operate under the form of a General clinic or a Specialized clinic
1. General clinic
Licensing conditions for polyclinics according to Articles 40 and 42 of Decree 96/2023/ND-CP are as follows:
1. Scale and organizational structure of the polyclinic:
a) 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;
b) 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.
Material facilities and personnel:
a) 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.
b) 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.
c) 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
Personnel:
a) 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);
b) 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;
c) 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;
d) Medical practitioners must be vested with tasks appropriate to their scope of practice approved by competent authorities;
đ) Medical technicians whose scope of practice involves medical laboratories 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.
e) 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;
g) 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.
h) 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.
* Specialized clinic
Licensing conditions for specialty clinics according to Articles 40 and 43 of Decree 96/2023/ND-CP are as follows:
1. Scale and organizational structure of the specialty clinic:
a) It has at least a specialty;
b) In case a specialty clinic 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, provided that activities of no more than 03 forms of organization of health facility are added.
Material facilities:
a) The specialty clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m2;
b) If techniques and minor surgery operations are performed, in addition to medical examination room(s), 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.
c) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the clinic has entered into a contract for sterilization of medical devices with another health facility.
The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.
Personnel:
a) 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);
b) 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;
c) 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;
d) Medical practitioners must be vested with tasks appropriate to their scope of practice approved by competent authorities;
đ) Medical technicians whose scope of practice involves medical laboratories 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.
e) 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;
g) 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.
h) 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.
The above is the legal advice of FDVN related to your consultation request based on research of legal regulations. We hope FDVN's advice will be helpful to you.
Tran Thi Ha - FDVN Law Firm
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