Health is always the factor that people care about the most, so medicine is one of the sectors that the state values ​​and is extremely strict in the processing stages. There is a very good saying “If you want to get well quickly, use Western medicine, if you want to get well completely, find Chinese medicine”. That is why people’s demand for treatment with traditional medicine is increasing day by day because Chinese medicine and Vietnamese medicine are prepared from herbal plants that are loved and trusted by many people. However, the number of traditional medicine clinics currently opened is still very limited because the licensing procedures are quite complicated and strict. For this type of medical clinic, in order to be established and operate legally in the form of a traditional medicine clinic, the medical facility needs to meet certain conditions, prepare documents and fully implement the Procedures for apply for a license to open a traditional medicine clinic. The following article of Viet My Law and Accounting will provide customers with detailed answers to the current and latest regulations in 2024 on applying for a license to open a traditional medicine clinic.

1. What is a traditional medicine clinic?

Traditional medicine is understood as a medical field that studies knowledge and experience in disease prevention and treatment that are applied to develop and summarize through many generations of each period. To operate in the traditional medicine industry, it is possible to establish medical examination and treatment facilities such as general hospitals, specialized hospitals, and clinics.

A traditional medicine clinic is one of the types of clinics of medical examination and treatment facilities stipulated in Article 2 of Decree 96/2023/ND-CP. Accordingly, a traditional medicine clinic is understood as a form of clinic following the traditional methods of traditional medicine.

2. Necessary conditions for being granted a license to open a traditional medicine clinic

In order for a traditional medicine clinic to operate legally, the clinic must complete the application procedures for a License to operate a traditional medicine clinic. A license to operate a traditional medicine clinic is granted when the clinic meets the general conditions for medical examination and treatment facilities specified in Article 40 and the specific conditions specified in Article 46 of Decree 96/2023/ND-CP. Specifically as follows:

* Regarding physical facilities

Like all other types of clinics, traditional medicine clinics must also have a fixed location, meeting the provisions of law on: load-bearing safety, fire prevention and fighting, infection control, environmental protection, radiation safety (if any); ensuring adequate electricity and water for the operation of the medical examination and treatment facility. At the same time, there must be signs, diagrams and signs guiding to departments, clinics, professional and administrative departments;

In addition, the clinic must have a place to receive patients, and the examination room must have a minimum area of ​​10m2.

Depending on the scope of registered professional activities, the traditional medicine clinic must meet the following additional conditions:

• In case of performing techniques and procedures, in addition to the examination room, there must be an additional room to perform techniques and procedures with a minimum area of ​​10m2; for example, if performing therapeutic physical techniques, the room to perform techniques and procedures must have a minimum area of ​​20m2;
• In case of medicinal steam bath, the steam room must have a minimum area of ​​2m2 and must be closed but have enough light in the room;
• In case of performing traditional medicine processing and preparation, it must meet the processing and preparation standards according to the regulations of the Minister of Health.

* Regarding medical examination and treatment equipment

If performing medical examination, prescription, and dispensing:

• There is a medicine cabinet, the medicinal herbs are stored in drawers or in glass or white plastic bottles with lids and clearly labeled with the medicinal herbs on the outside;
• There is a medicine scale and the medicinal herbs are divided into scales and medicine wrappers.

In the case of performing acupuncture, massage, and acupressure, there must be at least the following equipment:

• There is an acupuncture, massage, and acupressure bed for the patient;
• There are enough tools for acupuncture, massage, and acupressure;
• There are enough tools and instructions for handling acupuncture.

In the case of medicinal steaming: there must be a complete medicinal steaming system, regulating valve, steaming instruction board, and alarm system in case of emergency.

There must be an anaphylaxis first aid box and enough specialized emergency medicine suitable for the specialties within the scope of professional activities of the clinic.

* Regarding personnel

The specialized clinic must have enough practitioners according to the scale, scientific list and the ratio of practitioners as prescribed by the Minister of Health, and:

The person responsible for professional and technical matters must be a full-time practitioner of the facility and the scope of practice must be suitable for the professional activities of the clinic, with a minimum practice period of 36 months, except for practitioners with the title of traditional medicine practitioner, a person with a traditional medicine prescription, a person with a traditional treatment method.

Other subjects participating in the stage of medical examination and treatment but not required to be granted a practice license (medical physicists, radiotherapy engineers, biotechnology engineers, bachelors of biotechnology and other subjects) are allowed to perform professional activities as assigned by the person responsible for professional and technical matters of the medical examination and treatment facility, the assignment must be suitable for the professional qualifications and capabilities of that person.

In addition, the person responsible for the technical expertise of the traditional medicine clinic must be a practitioner with one of the following professional titles:

• Doctor with scope of practice of traditional medicine;
• Doctor with traditional medicine specialty practice.

Note: to practice traditional medicine, it is necessary to prepare documents to be granted a License to practice medical examination and treatment for the professional title of doctor. To be granted a License to practice, it is necessary to meet the conditions prescribed in Clause 2, Article 30 of the Law on Medical Examination and Treatment 2023. In particular, it is necessary to pay attention to reviewing the capacity to practice for the title of traditional medicine doctor according to Section 2, Chapter II of Decree 96/2023/ND-CP.

3. Application for a license to open a traditional medicine clinic in 2024

(1) Application for a license to operate;

(2) Certificate of business registration or decision to establish a medical examination and treatment facility (for organizations);

(3) Legal practice certificate of the person responsible for the technical expertise of the clinic;

(4) List of registered practitioners at the clinic including: registration of practitioners and medical professionals at the clinic. These people include: cashier; security guard; accountant; receptionist – not subject to the requirement of a practice certificate;

(5) List of facilities; medical equipment, business and personnel of the medical examination and treatment facility;

(6) Documents proving that the clinic meets the conditions on facilities, medical equipment, and personnel organization suitable for the professional operation framework of the clinic such as: certificate of land use rights with house lease contract (if any) to prove and ensure the conditions on minimum area according to regulations; contracts, documents on purchasing equipment at the clinic, etc.;

(7) The list of technical expertise of the clinic has been proposed based on the list of technical expertise issued by the Minister of Health (the head must establish it).

4. Procedures for apply for a license to open a traditional medicine clinic

Step 1: Submit documents and fees

The traditional medicine clinic submits 01 set of documents including the above documents to apply for an operating license to the Ministry of Health or the Department of Health according to regulations.

Along with submitting the documents, the clinic must also pay an appraisal fee. According to Circular 59/2023/TT-BTC, the appraisal fee for granting an operating license for a traditional medicine clinic is VND 3,100,000.

Step 2: Receive documents

The Ministry of Health or the Department of Health receives and sends a Document Receipt to the applicant. After receiving the application for an operating license, the agency continues to perform as follows:

In case the application is submitted directly to the agency receiving the application, after receiving the application, the agency is responsible for immediately sending the Application Receipt to the facility requesting the operating license.
In case the dossier is sent by post, within 03 days from the date of receipt of the documents (calculated from the postmark), the receiving agency will send the facility requesting the issuance of an operating license a Dossier Receipt as prescribed.

Step 3: Processing the dossier

In case there is no request to amend or supplement the dossier:

• The licensing agency will organize the appraisal of the operating conditions and the list of techniques performed at the requesting facility and make a record of the appraisal within 60 days from the date recorded on the dossier receipt;
• In case there is no request for amendment or supplementation, a new operating license must be issued and a decision approving the list of techniques performed at the facility must be issued within 10 working days from the date of issuance of the appraisal record;
• In case there is a proposal for amendment or supplementation, it must be clearly stated in the content of the appraisal record.
• Within 10 working days from the date of receipt of the notification and documents proving the completion of the remediation and repair of the requesting facility, the licensing authority may conduct an inspection of the remediation and repair of the requesting facility if necessary or issue the operating license. In case of refusal to issue the operating license, a written response must be issued stating the reasons.

In case of a request to amend or supplement the dossier:

• The licensing authority must send a written request to the facility, in which it must specifically state which documents and contents need to be amended or supplemented within 10 days from the date recorded on the application receipt.
• After amending or supplementing the documents, the facility is required to send a written notice and documents proving the completion of the amendment or supplement.
• After receiving the revised and supplemented dossier, the licensing authority is responsible for carrying out the procedures according to regulations in cases where there is no longer a request for revision or supplementation and in cases where the facility has revised and supplemented but does not meet the requirements.

Step 4: Issuing and managing the operating license of the clinic

The operating license will be made in 2 copies: 1 copy is issued to the requesting facility and 1 copy is kept at the licensing authority, except in cases where the results have been returned on the electronic information portal.

Within 5 working days from the date of granting the operating license of the traditional medicine clinic, the licensing authority shall publish on its electronic information portal and on the Information System on management of medical examination and treatment activities the following information: name and address of the facility granted the operating license; full name and practice license number of the person responsible for professional and technical expertise; operating license number; scope of professional activities and duration of professional activities.

Note:

If the traditional medicine clinic has been granted an operating license but changes its organizational form or location, it is necessary to carry out procedures to request a re-issuance of the operating license.

Traditional medicine clinics that have changed their name, address (without changing the location), and working hours need to carry out procedures to request adjustments to the contents of their operating license.

Traditional medicine clinics that have been granted an operating license, if they want to change the owner but do not change the name of the facility, scale, scope of the clinic’s operations, or location, do not need to carry out procedures to request a new operating license.

The above is the consulting content of Viet My Law and Accounting on “Apply for a license to open a traditional medicine clinic”. This is a type of clinic that provides examination and treatment services using traditional medicine methods and must comply with the provisions of the law for the health of the community. In case you have any questions about this issue or other legal issues, please contact us for quick advice and resolution.