Procedures for amending the license to provide medical services in Vietnam as of March 29, 2024

Procedures for amending the license to provide medical services in Vietnam as of March 29, 2024 (Internet image) 

Regarding this matter, LawNet would like to answer as follows:

On March 29, 2024, the Minister of Health issued Decision 743/QD-BYT amending and supplementing Decision 159/QD-BYT dated January 18, 2024.

Procedures for amending the license to provide medical services in Vietnam as of March 29, 2024

* Case 1: Case of changing working hours or changing the name, address of the medical facility, but not changing the location.

- Step 1:

Submiting 01 set of documents requesting changes to the name, address, and working hours of the medical facility according to the regulations in Clause 1 of Article 64 of Decree 96/2023/ND-CP and pay fees as prescribed by law on fees and charges for the licensing authority.

- Step 2:

Upon receiving the documents, the licensing authority will return to the facility a receipt for the submitted documents according to Form 02 in Appendix I issued with Decree 96/2023/ND-CP.

- Step 3:

In case there is no request for amending or supplementing the documents, the licensing authority shall adjust the operating license within 20 days from the date indicated on the receipt in Clause 2 Article 65 of Decree 96/2023/ND-CP.

- Step 4:

In case there is a request for amending or supplementing the documents, within 05 working days from the date indicated on the receipt in Clause 2 Article 65 of Decree 96/2023/ND-CP, the licensing authority shall send a written request to the facility, specifying the specific documents, content that needs to be amended, supplemented.

Within 06 months from the date of issuance of the operating license, the facility must submit the amended documents as requested. After the above deadline, if the facility does not make amendments or supplements, the submitted documents will no longer be valid.

- Step 5:

After receiving the application for amendment or supplementation, the licensing authority shall return the receipt to the requesting establishment according to Form 02 Appendix I issued together with Decree 96/2023/ND-CP for the amended or supplemented application:

+ In case the amended or supplemented application does not meet the requirements, the licensing authority must notify the requesting establishment in writing according to the provisions in Clause 4 Article 65 of Decree 96/2023/ND-CP.

Within 6 months from the date the licensing authority issues the notification of amendment or supplementation, the requesting establishment must submit the amended or supplemented application as required. After the above-mentioned deadline, if the requesting establishment does not amend or supplement the application, or after 12 months from the date of the first submission, if the supplemented application does not meet the requirements, the submitted application will no longer be valid.

+ In the event that there is no requirement for amendment or supplementation to the amended or supplemented application, the licensing authority shall carry out the provisions in Clause 3 of Article 65 of Decree 96/2023/ND-CP.

- Step 6:

Within 5 working days from the date of issuing the operating license, the licensing authority shall announce and update on its electronic information portal and on the information system for the management of medical examination and treatment activities all relevant information regarding the adjusted content.

* Case 2: Case of changing the scale of activities, the scope of professional activities, or supplementing, reducing the technical list of the medical examination and treatment establishment.

- Step 1:

Submitting 01 set of documents according to the provisions in Clause 2 Article 64 of Decree 96/2023/ND-CP and pay fees according to the provisions of the law on fees and charges to the licensing authority.

- Step 2:

After receiving the application, the licensing authority shall issue a receipt for the requesting establishment.

- Step 3:

In case there is a requirement for amendment or supplementation of the application, within 7 working days from the date stated on the receipt, the licensing authority must send a written document to the requesting establishment, specifying the specific documents and content that need to be amended or supplemented.

Within 6 months from the date the licensing authority issues the notification of amendment or supplementation, the requesting establishment must submit the amended or supplemented application as required. After the above-mentioned deadline, if the requesting establishment does not amend or supplement the application, the submitted application will no longer be valid.

- Step 4:

After receiving the amended or supplemented application, the licensing authority shall return the receipt for the requesting establishment:

In case the amended or supplemented application does not meet the requirements, the licensing authority must notify the requesting establishment in writing according to the provisions in Clause 3 of Article 66 of Decree 96/2023/ND-CP.

Within 6 months from the date the licensing authority issues the notification of amendment or supplementation, the requesting establishment must submit the amended or supplemented application as required.

After the above-mentioned deadline, if the requesting establishment does not amend or supplement the application, or after 12 months from the date of the first submission, if the supplemented application does not meet the requirements, the submitted application will no longer be valid.

- Step 5:

In case there is no request for modification, supplementation of the dossier, or the documents have been completed in accordance with the provisions in Clause 3, 4 of Article 66 of Decree 96/2023/ND-CP, the licensing authority:

+ Issue a document permitting changes in the operating scale, scope of professional activities, or addition or reduction of technical categories within 20 days from the date recorded on the receipt if it does not fall under the case of not conducting on-site verification.

+ The licensing authority shall conduct on-site verification and prepare a verification report within 60 days from the date recorded on the receipt for cases requiring on-site verification; the verification report must clearly state the required amendments, supplements (if any).

- Step 6:

After conducting on-site verification, the licensing authority is responsible for:

+ Issuing a document permitting changes in the operating scale, scope of professional activities, or addition, reduction of technical categories within 10 working days from the date of issuing the verification report for cases without requests for modification, supplementation;

+ Issuing a document notifying the contents that need to be rectified, repaired within 05 working days from the date of issuing the verification report for cases with requests for modification, supplementation.

Within 06 months from the date the licensing authority notifies the contents that need to be modified, supplemented but the establishment fails to complete the amendments, supplements, the submitted dossier shall no longer be valid.

Step 7:

Within 10 working days from the date of receiving the notification and documents proving the completion of the amendments, supplements requested by the establishment, the licensing authority:

+ Issues a document permitting changes in the operating scale, scope of professional activities, or addition, reduction of technical categories for cases that do not require on-site verification of the amendments, supplements requested by the establishment;

+ Conducts on-site verification of the amendments, supplements requested by the establishment in cases that require on-site verification:

++ Issuing a document permitting changes in the operating scale, scope of professional activities, or addition, reduction of technical categories for cases where the establishment has completed the amendments, supplements;

++ Providing a written response stating the reasons for not allowing changes in the operating scale, scope of professional activities, or addition, reduction of technical categories if the establishment has completed the amendments, supplements.

- Step 8:

Within 05 working days from the date of allowing the addition of technical categories, the licensing authority shall announce, update on its electronic information portal or website and on the information system for managing medical examination and treatment activities all information related to the adjustment content.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE