Procedures for issuing a new license to provide medical services (latest) in Vietnam

Procedures for issuing a new license to provide medical services (latest) in Vietnam (Internet image)

On March 29, 2024, the Ministry of Health issued Decision 743/QD-BYT on amending Decision 159/QD-BYT dated January 18, 2024 announcing newly issued, replaced, and annulled administrative procedures in Vietnam under the Ministry of Health specified in the Law on Medical Examination and Treatment 2023 and Decree 96/2023/ND-CP.

Procedures for issuing a new license to provide medical services (latest) in Vietnam

(1) Implementation process

Step 1: Submitting 01 set of application documents for a new license and pay fees as prescribed by law for the competent authority to grant an operating license (hereinafter referred to as the licensing authority).

Step 2: After receiving the documents, the receiving agency shall issue a receipt for the application documents according to Form 02 Appendix I issued together with Decree 96/2023/ND-CP.

Step 3:

- In case there is no request for amendment or supplementation of the documents:

+ The licensing authority shall organize the evaluation of the operating conditions and the list of technical implementations at the requesting establishment and prepare an evaluation report within 60 days from the date recorded on the receipt for the application documents;

+ In case there is no request for amendment or supplementation, a new operating license must be issued; and a decision approving the list of technical implementations at the establishment must be issued within 10 working days from the date of issuing the evaluation report;

+ If there is a request for amendment or supplementation, it must be clearly stated in the content of the evaluation report.

Within 10 working days from the date of receiving the notification and supporting documents proving the completion of the requested rectification and repair by the requesting establishment, the licensing authority may conduct on-site inspections of the rectification and repair by the requesting establishment if necessary or proceed with the issuance of the operating license. If the operating license is not granted, a written response stating the reasons must be provided.

- In case there is a request for amendment or supplementation of the documents:

+ The licensing authority must send a written notice to the requesting establishment, specifying the specific documents and content that need to be amended or supplemented within 10 days from the date recorded on the receipt for the application documents;

+ After amending or supplementing the documents, the requesting establishment shall send a notification and supporting documents proving the completion of the amendment or supplementation;

+ After receiving the amended or supplemented documents, the licensing authority is responsible for following the prescribed procedures:

++ At Clause 3 of Article 61 of Decree 96/2023/ND-CP for cases where there is no longer a request for amendment or supplementation;

++ At points a and b of Clause 4 of Article 61 of Decree 96/2023/ND-CP for cases where the establishment has amended or supplemented but has not yet met the requirements.

Within 05 working days from the date of issuing the operating license, the licensing authority shall announce on its electronic information portal and on the Ministry of Health's information system on the management of medical examination and treatment activities the following information: the name and address of the licensed establishment; the full name and professional license number of the person responsible for technical expertise; the operating license number; the scope of professional activities; and the duration of professional activities.

(2) Implementation methods

- Online

- Directly

- Public postal service

(3) The application includes:

(3.1) Case 1: Application for a new license for operating activities in cases specified in points a, b, c, d, đ, e, clause 1, Article 59 of Decree 96/2023/ND-CP:

- Application according to Form 02 Appendix II issued together with Decree 96/2023/ND-CP;

- Valid copy of the establishment decision or document with the name of the state authority for the healthcare facility or the business registration certificate for the private healthcare facility or the investment certificate for the healthcare facility with foreign investment;

- Valid copy of the professional practice license and confirmation of professional practice process according to Form 11 Appendix I issued together with Decree 96/2023/ND-CP by the person in charge of the technical expertise of the healthcare facility (not applicable in cases where these documents have been connected, shared on the healthcare management information system or the national health database);

- Valid copy of the professional practice license and confirmation of professional practice process according to Form 11 Appendix I issued together with Decree 96/2023/ND-CP by the person in charge of the professional department of the healthcare facility (not applicable in cases where these documents have been connected, shared on the healthcare management information system or the national health database);

- Declaration of infrastructure, list of medical equipment, list of personnel meeting the conditions for granting corresponding operating licenses for each organizational form according to Form 08 Appendix II issued together with Decree 96/2023/ND-CP and supporting documents confirming these declarations;

- List stating the full name and professional practice license number of each registered practitioner at the facility according to Form 01 Appendix II issued together with Decree 96/2023/ND-CP;

- Document approved by the competent authority stipulating the functions, tasks, organizational structure of the state hospital or the charter of organization and operation of the private hospital according to Form 03 Appendix II issued together with Decree 96/2023/ND-CP;

- List of professional expertise of the healthcare facility proposed based on the list of professional expertise issued by the Minister of Health;

- In case of applying for the first-time issuance of a license for operating a humanitarian healthcare facility or a healthcare facility not for profit, there must be documents proving the financial source ensuring the healthcare activities for humanitarian patients or healthcare activities not for profit.

(3.2) Case 2: Application for a license for operating activities in cases where a license has been granted but there is a change of location according to the provisions at point d, clause 1, Article 59 of Decree 96/2023/ND-CP:

- Application according to Form 02 Appendix II issued together with Decree 96/2023/ND-CP;

- Valid copy of the establishment decision or document with the name of the state authority for the healthcare facility or the business registration certificate for the private healthcare facility or the investment certificate for the healthcare facility with foreign investment;

- Declaration of infrastructure meeting the conditions for granting operating licenses at the new location and supporting documents confirming these declarations;

- Valid copy of the granted operating license.

(3.3) Case 3: Application for a new license for operating activities for a facility that has been granted a license but requests to switch to operating according to the model of humanitarian healthcare or operating without profit, not charging medical examination and treatment fees for patients as prescribed at point g, clause 1, Article 59 of Decree 96/2023/ND-CP:

- Application according to Form 02 Appendix II issued together with Decree 96/2023/ND-CP;

- Documents proving the financial source for healthcare activities for humanitarian patients.

(4) Processing time: The organization shall assess the operating conditions and technical list at the proposed facility and prepare an assessment report within 60 days from the date of receiving the complete dossier and;

10 working days from the date of issuing the assessment report or receiving the notification and supporting documents proving the completion of the rectification and repair work of the proposed facility.

More details can be found in Decision 743/QD-BYT taking effect on March 29, 2024.

Ho Quoc Tuan

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