Condition and procedure for applying for a dental clinic operation license

Health and aesthetics are the top concerns for people in the current context. Therefore, more and more private clinics have been established to ensure the needs of people, especially the dental clinics of domestic and foreign enterprises. Hence, How to set up a Dental Clinic, Condition, and procedure for applying for a dental clinic operation license … These are the problems most businesses encounter when they plan to set up a Dental Clinic

In order to provide information about these issues to facilitate the implementation process and help enterprise to avoid violation of Vietnam Law. Bizlawyer will advise on the specific conditions and procedures for applying a Dental Clinic operating license in Vietnam

I. Legal documents

1. Law on Medical Examination and Treatment 2009;
2. Decree 109/2016/ND-CP regulating the issuance of practice certificates for practitioner and operation licenses for medical examination and treatment establishment;
3. Decree 155/2018/ND-CP amending and supplementing a number of provisions related to business investment conditions under the state management scope of the Ministry of Health;
4. Decision 3207/QD-BYT promulgating guidelines on technical procedures for medical examination and treatment of maxillofacial teeth

II. Regulations on licensing conditions for operating the Dental Clinic

Dental clinic is a type of medical examination and treatment establishment in the form of specialized clinic. Accordingly, the application for an operating license is governed by Law on Examination and Treatment 2009; Decree 109/2016/ND-CP; Decree 155/2018/ND-CP

Pursuant to Article 11 of Decree No. 155/2018/ND-CP, a dental clinic must satisfy the following specific conditions

1.1. Conditions on facilities

• To Have a fixed location;
• To Satisfy radiation safety, fire prevention, and fighting conditions in accordance with law;
• To Arrange sterilized area to handle re-used medical equipment, except having no sterilized equipment or signing contract with other medical establishments to sterilize the equipment;
• The specialized clinic must have a medical examination and treatment room with an area of ​​at least 10 m2 and a place for the reception of patient (excluding the waiting area for examination), divided into two-room for medical examination and counseling for patients;
• In case of a Specialized Clinic having more than 01 dental chair, the area for each dental chair must be at least 5 m2;
• In case a specialized clinic using radiation equipment (including dental X-ray equipment attached to dental chair), it must satisfy the provisions of the law on radiation safety; and
• In case of performing medical procedure, including implanting techniques, there must be a room or a separate area for performing medical procedure. The room or area where the procedure is performed must have sufficient area for performing professional techniques

1.2. Medical equipment

• To have sufficient medical equipment satisfying operation scope of medical examination and treatment establishment; and
• To have an anti-shock drugs box and sufficient specialized emergency drugs

1.3. Staff

Each medical examination and treatment establishment must have an individual in charge of professional and technical matters. This person must satisfy the following conditions:

• Hold a doctor position with a practicing certificate suitable to the job major: teeth, jaw, face.
• Have practiced medical examination and treatment for at least 36 months after being granted a practicing certificate or have directly participated in medical examination and treatment for at least 54 months in the fields of teeth, jaw, face; and
• Work at the examination and treatment establishment;

Other staffs working at specialized Clinic in case of conducting medical examination and treatment, they must have practice certificate and be assigned jobs in accordance with the scope of professional practice as stated in the practice certificate

III. Procedure for applying for a dental clinic operation license

Licensing Agency: Department of Health (“DOH”) of the province/city where the clinic is located

Procedure

Step 1: Submit applications

A dental clinic applying for an operation license shall submit one set of document, including

• An application for an operation license;
• A valid copy of the establishment decision or a document with the name of the medical examination and treatment establishment, issued by a competent state agency, or business registration for private medical examination and treatment establishment or investment certificate for foreign-invested medical examination and treatment establishment;
• A valid copy of the practicing certificate of individual who has the responsibility of professional and technical matters of the medical examination and treatment establishment; other staffs of medical examination and treatment establishment who perform the specialized job;
• A list of practitioners’ registration at a medical examination and treatment establishment (including registration of medical practitioners and individuals who perform the specialized job but not required to hold a practicing certificate;
• A list of facilities, medical equipment, organization and staff of the medical examination and treatment establishment;
• Proofs show that the medical examination and treatment establishment satisfies conditions on facilities, medical equipment and appropriate human organization to the scope of professional activities; and
• The list of technical and professional qualifications of medical examination and treatment establishment proposed pursuant to the basis of the list of technical expertise issued by the Minister of Health

Step 2: Receive and check the file

After receiving the dossier, the DOH will send a Receipt note to the clinic

Step 3: Verify and approve document the file

In the case of valid dossiers, the DOH shall consider and appraise dossiers within 45 working days from the date stated in the Receipt note.

Step 4: Get results

Based on the result-receiving date on the Receipt note, the clinic requests the DOH that it has received the dossier to receive the result.

Result: License for the operation of medical examination and treatment establishment [dental clinic]

Processing time: 45 working days from the date stated on the Receipt note.

Conclusion

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