Resolution on Streamlining and Simplifying Business Operation Conditions, Administrative Procedures, and Delegation of Authority for the Implementation of Administrative Procedures in the Field of Healthcare

 

RESOLUTION
ON REDUCING AND SIMPLIFYING BUSINESS REGISTRATION CONDITIONS, ADMINISTRATIVE PROCEDURES, AND AUTHORITY DELEGATION FOR THE IMPLEMENTATION OF ADMINISTRATIVE PROCEDURES IN THE HEALTHCARE SECTOR

BASED ON The Law on Organization of the Government No. 63/2025/QH15;

The Law on Organization of Local Administration No. 72/2025/QH15;

The Law on Issuing Normative Legal Documents No. 64/2025/QH15, as amended and supplemented by the Law No. 87/2025/QH15;

Pursuant to the proposal of the Minister of Health;

The Government promulgates this Resolution on reducing and simplifying business registration conditions, administrative procedures, and authority delegation for the implementation of administrative procedures in the healthcare sector.

Article 1. Scope of Application

This Resolution stipulates the reduction and simplification of business registration conditions, administrative procedures, and authority delegation for the implementation of administrative procedures in the healthcare sector within the purview of the Government.

Article 2. Authority Delegation for Administrative Procedures in the Healthcare Sector

1. Authority Delegation for Administrative Procedures Concerning Food Safety:

a) The issuance of certificates confirming advertising content for health food products as provided in paragraph 5 of Article 27 of Decree No. 15/2018/NĐ-CP, which details the implementation of certain provisions of the Law on Food Safety, is within the authority of the Chairperson of the People's Committee at the provincial level;

b) The application form and procedures are in accordance with those specified in Appendix I attached to this Resolution.

2. Authority Delegation for Administrative Procedures Concerning Disease Prevention:

a) The request for importation of disease samples as provided in Article 36 of Decree No. 89/2018/NĐ-CP, which details the implementation of certain provisions of the Law on Prevention and Control of Infectious Diseases, as amended by Decree No. 155/2018/NĐ-CP, is within the authority of the Chairperson of the People's Committee at the provincial level;

b) The application form and procedures are in accordance with those specified in Appendix II attached to this Resolution.

3. Authority Delegation for Administrative Procedures Concerning Issuance of Practice Licenses:

a) The issuance, renewal, extension, amendment, suspension, or revocation of practice licenses for medical treatment and diagnosis (including certificates of practice for medical treatment and diagnosis issued in accordance with the provisions of Law No. 40/2009/QH12 on Medical Treatment and Diagnosis, hereinafter referred to as "practice license" for entities specified at point a, paragraph 1, Article 28 of the Law on Medical Treatment and Diagnosis and paragraph 8 of Article 143 of Decree No. 96/2023/NĐ-CP, which details certain provisions of the Law on Medical Treatment and Diagnosis) is within the authority of the Chairperson of the People's Committee at the provincial level;

b) The application form and procedures are in accordance with those specified in Appendix III attached to this Resolution.

4. Authority Delegation for Administrative Procedures Concerning Issuance of Operating Licenses:

a) The authority to renew, amend operating licenses for medical treatment and diagnosis where there is a change in working hours or name and address of the medical facility but no change in location for private hospitals as provided in Articles 63 and 65 of Decree No. 96/2023/NĐ-CP is within the authority of the Chairperson of the People's Committee at the provincial level;

b) The application form and procedures are in accordance with those specified in Appendix IV attached to this Resolution.

Article 3. Reduction and Simplification of Business Conditions in the Field of Healthcare

1. No business conditions are prescribed concerning biosafety at laboratories as stipulated in Articles 5, 6, and 7 of Decree No. 103/2016/NĐ-CP on Ensuring Biosafety at Laboratories, which have been amended and supplemented by Decree No. 155/2018/NĐ-CP.

2. No business conditions are prescribed concerning vaccination services as stipulated in Article 9 and Article 10 of Decree No. 104/2016/NĐ-CP on Vaccination Activities, which have been amended and supplemented by Decree No. 155/2018/NĐ-CP.

3. No business conditions are prescribed concerning the organization of practical training in healthcare-related fields as stipulated in Article 8, Article 9, Clause 2 of Article 10, and Articles 11, 140 of Decree No. 111/2017/NĐ-CP on Organizing Practical Training in Healthcare-Related Fields and Article 140 of Decree No. 96/2023/NĐ-CP.

4. No business conditions are prescribed concerning the provision of treatment services for opiate addiction using substitution therapy as stipulated in Articles 16 and 17 of Decree No. 141/2024/NĐ-CP on Detailed Implementation of Certain Provisions of the Law on Prevention and Control of Viral Infections Causing Acquired Immunodeficiency Syndrome (AIDS).

5. No business conditions are prescribed concerning the provision of HIV counseling, testing services as stipulated in Clause 2 of Article 38, Articles 39, 40, and 41 of Decree No. 141/2024/NĐ-CP and Clauses 1 and 2 of Article 5 of Decree No. 63/2021/NĐ-CP on Detailed Implementation of the Law Amending and Supplementing Certain Provisions of the Law on Prevention and Control of Viral Infections Causing Acquired Immunodeficiency Syndrome (AIDS).

6. No business conditions are prescribed concerning the provision of medical examination, treatment services as stipulated in Article 5; Clauses 1 and 2 of Article 6; Clause 4 of Article 7; Article 8; Clauses 1, points a and b of Clause 2, points a, d, e of Clause 4, various Clauses 5, 6, 7, 8, 9, 10, and 11 of Article 40; points a and b of Clause 2, Clause 3, paragraph 7 point b of Clause 4 of Article 41; point b of Clause 1 of Article 42; Clause 1 of Article 43; Clauses 1 and 2 of Article 44; various Clauses 1, 2 and 3 of Article 45; point d of Clause 2 of Article 46; Clause 3 of Article 47; Clause 1 of Article 48; Clause 1 and Clause 3 of Article 49; points b of Clauses 1 and 2 of Article 50, Clause 3 of Article 51; Clause 5 of Article 53; Clause 2 of Article 55; Articles 127, 128, 129, 131, 133, 135 of Decree No. 96/2023/NĐ-CP.

Article 4. Reduction and Simplification of Administrative Procedures in the Field of Healthcare

1. The following administrative procedures are not implemented:

a) The procedure for registering product declarations for food additives with new functions, food additives not included in the list of approved food additives or not within their intended use as prescribed by the Ministry of Health under Clause 3 of Article 6 of Decree No. 15/2018/NĐ-CP;

b) The procedure for issuing, renewing, self-declaration and revocation of certificates of laboratory accreditation meeting biosafety standards as stipulated in Articles 11, 12, 13, and 14 of Decree No. 103/2016/NĐ-CP, which have been amended and supplemented by Decree No. 155/2018/NĐ-CP;

c) The procedure for declaring compliance with vaccination service requirements as stipulated in Article 11 of Decree No. 104/2016/NĐ-CP, which have been amended and supplemented by Decree No. 155/2018/NĐ-CP;

d) The procedure for declaring compliance with opiate addiction treatment using substitution therapy as stipulated in Articles 19, 20, 21, and 22 of Decree No. 141/2024/NĐ-CP;

e) The procedure for issuing certificates of educational institution accreditation meeting examination and certification requirements or sufficient proficiency in the Vietnamese language or other languages or translation skills in medical examinations as stipulated in Articles 141 and 142 of Decree No. 96/2023/NĐ-CP.

2. Simplification of administrative procedures related to medical examination and treatment:

a) Reduction of processing time for the procedure declaring healthcare facilities meeting requirements as instructional institutions, as specified in Clause 3 of Section B Part 11 of Annex II to Decree No. 148/2025/NĐ-CP on Delegation and Hierarchical Authority in the Healthcare Field:

“3. Within a period of 10 working days from the date noted on the application form for declaration as specified in Clause 6, Paragraph 3 of Decree No. 96/2023/NĐ-CP, the receiving authority shall be responsible for publishing information about the instructional institution on the official website or electronic information platform and on the system managing healthcare activities.

In case of non-compliance, the receiving authority must send a written notice to the healthcare facility and specify the reasons.

The minimum published information includes: name, address of the instructional institution, scope of instruction (if there are linked institutions providing instruction, both content and names of such institutions must be published).

If after 10 working days from the date noted on the application form for declaration, the receiving authority has not sent a written notice to the healthcare facility regarding non-compliance as an instructional institution or failed to publish information according to Clause 4, Paragraph 6 of Decree No. 96/2023/NĐ-CP, the instructional institution may begin operating its instruction activities.”

b) Reduction of processing time for the procedure requesting recognition of foreign issued practice permits as specified in Clauses b and c of Paragraph 3 of Article 37 of Decree No. 96/2023/NĐ-CP:

“b) For cases where the applicant has a practice permit issued by an authority or organization authorized to issue such permits in another country, which has been evaluated for recognition:

"b) In the case of an application for examination and recognition of a practice permit where the practice permit was issued by a licensing authority or organization in a foreign country that has been evaluated for recognition:"

- Within twenty working days from the date of receipt, the Ministry of Health must issue a written response regarding the recognition or non-recognition of the practice permit;

- In cases where verification is required concerning foreign training of the practitioner, the period for recognition shall be twenty working days from the date of the verification results.

c) For cases where the applicant requests consideration for recognizing the practice permit and such permit was issued by a foreign licensing authority whose evaluation has not yet been conducted:

- The Ministry of Health shall conduct the evaluation to recognize according to the provisions in Article 38 of this Decree;

- Within twenty working days from the date of the evaluation results, the Ministry of Health must issue a written response regarding the recognition or non-recognition of the practice permit;

- In cases where verification is required concerning foreign training of the practitioner, the period for recognition shall be twenty working days from the date of the verification results.

c) Reduction in the time to implement for the procedure of issuing a new operating license for medical treatment and diagnosis as provided in Article 61 of Decree No. 96/2023/NĐ-CP is as follows:

“1. Submit one set of application documents for issuance and pay fees according to the provisions of the law on fees and charges to the licensing authority (hereinafter referred to as the licensing authority).

2. After receiving the application, the receiving authority shall issue a receipt form to the applying entity in accordance with Form 02 attached to this Decree.

3. In cases where there are no requests for amendments or supplements:

a) The licensing authority shall organize an inspection of operating conditions and technical service list at the applying entity within forty working days from the date recorded on the receipt form;

b) In cases where there are no requests for amendments or supplements, a new operating license shall be issued and a decision approving the technical service list at the entity shall be made within ten working days from the date of issuance of the inspection report;

c) In cases where there are requests for amendments or supplements, such details must be specified in the content of the inspection report.

Within ten working days from the receipt of the notification and supporting documents proving completion of corrective actions by the applying entity, the licensing authority may conduct a practical check on the corrective actions taken by the applying entity if necessary, or proceed with issuing the operating license. In cases where the operating license is not issued, a written response must be provided along with the reasons.

4. In cases where there are requests for amendments or supplements:

a) The licensing authority shall issue a written notice to the applying entity specifying the documents and content that need to be amended or supplemented within ten working days from the date recorded on the receipt form.

b) After amending or supplementing the application, the applying entity shall submit a notification and supporting documents proving completion of the amendments or supplements.

c) Upon receiving the amended or supplemented application, the licensing authority is responsible for implementing the procedures as prescribed:

- Paragraph 3 of this Article in cases where there are no further requests for amendments or supplements;

- Points a and b of this paragraph in cases where the entity has made amendments or supplements but does not meet the requirements.

5. Within five working days from the issuance of the operating license, the licensing authority shall publicly announce on its electronic information portal and the System for Managing Medical Treatment Operations the following information: name and address of the entity issued the operating license; names and practice permit numbers of technical professionals responsible; operating license number; scope of professional activities and duration of such activities.

6. The operating license shall be prepared in two copies according to Form No. 06 attached to this Decree: one copy for the applying entity, and one copy retained by the licensing authority except where results are provided electronically.

7. In cases where the entity is issued an operating license under a corporate form as a hospital, when issuing the operating license, the licensing authority shall issue a temporary document to rank the hospital at the basic level. The temporary ranking period is two years from the date recorded on the temporary ranking document. Sixty days before the end of the temporary ranking period, the hospital must submit an application for professional technical ranking according to Article 90 of this Decree.

d) Reduction in the time to implement for the procedure of adjusting the operating license for medical treatment and diagnosis for cases involving changes in operational scale, scope of professional activities or addition/removal of technical service list as provided in Article 66 of Decree No. 96/2023/NĐ-CP is as follows:

“1. Submit one set of application documents according to paragraph 2 of Article 64 of this Decree and pay fees according to the provisions of the law on fees and charges to the licensing authority.

2. After receiving the application, the licensing authority shall issue a receipt form to the applying entity.

3. In cases where there are requests for amendments or supplements, within seven working days from the date recorded on the receipt form, the licensing authority must issue a written notice to the applying entity specifying the documents and content that need to be amended or supplemented.

Within six months from the date of notification by the licensing authority regarding amendments or supplements, the applying entity shall submit an application for amendment or supplement according to requirements. After this period, the submitted application will no longer be valid.

4. Upon receiving the amended or supplemented application, the licensing authority shall issue a receipt form for the amended or supplemented application to the applying entity:

In cases where the amended or supplemented application does not meet the requirements, the licensing authority must notify the applying entity in accordance with paragraph 3 of this Article.

Within six months from the date of notification by the licensing authority regarding amendments or supplements, the applying entity shall submit an application for amendment or supplement according to requirements.

After this period, if no amendments or supplements are made or after twelve months from the first submission and the supplementary application does not meet the requirements, the submitted application will no longer be valid.

5. In case there is no request for amendment or supplementation of the file, or where the file has been completed in accordance with the provisions of Clause 3 and Clause 4 hereof, the licensing authority:

a) Shall issue a document permitting changes to the scale of operations, scope of professional activities, or addition or reduction of technical categories within fifteen working days from the date recorded on the receipt form if no on-site inspection is required at the facility;

b) The licensing authority shall conduct an on-site inspection and prepare an inspection report within forty working days from the date recorded on the receipt form in case an on-site inspection is required, and the inspection report must specify any amendments or supplements (if applicable).

6. After conducting a site inspection, the licensing authority shall:

a) Issue a document permitting changes to the scale of operations, scope of professional activities, or addition or reduction of technical categories within ten working days from the date of issuance of the inspection report if no amendments or supplements are required;

b) Issue a document notifying the items that need rectification and correction within five working days from the date of issuance of the inspection report in case amendments or supplements are required.

Within six months from the date of notification by the licensing authority regarding the items requiring amendment or supplementation, if the facility fails to complete such amendments or supplements as requested, the submitted file shall no longer be valid.

7. Within ten working days from the receipt of the notification and supporting documents proving that the facility has completed the required amendments or supplements:

a) Issue a document permitting changes to the scale of operations, scope of professional activities, or addition or reduction of technical categories in cases where no on-site verification is needed for the proposed amendments or supplements;

b) Conduct an on-site inspection of the proposed amendments or supplements in cases where such inspections are required:

- Issue a document permitting changes to the scale of operations, scope of professional activities, or addition or reduction of technical categories if the facility has completed the required amendments or supplements;

- Provide a written response and specify reasons for not permitting changes to the scale of operations, scope of professional activities, or addition or reduction of technical categories if the facility has not yet completed the required amendments or supplements.

8. Within five working days from the approval of additional technical categories:

The licensing authority shall publish and update relevant information on its electronic portal or website, as well as in the system for managing medical treatment activities.

9. The document permitting addition of technical categories is to be prepared in two copies: one copy for the requesting facility and one retained by the licensing authority except where results are provided electronically.

10. For cases involving the addition of special category techniques:

a) The medical treatment facility shall submit one set of documents as per the provisions of Clause 2, Article 64 of this Decree to the Ministry of Health for consideration of the feasibility of implementing such special category techniques.

b) Within five working days from receipt of the application, the Ministry of Health shall assess and evaluate the level and capability of the medical treatment facility to implement these special category techniques to determine whether a pilot project is required or if the facility meets the conditions for conducting a pilot project.

c) In cases where a pilot project of a special category technique is necessary, it must be carried out in accordance with the procedures specified in Article 97 of this Decree.

d) For cases where the medical treatment facility has completed the implementation of the pilot project for a special category technique and submitted a written report detailing the results of the pilot project along with recommendations for formal implementation, the following actions are required:

- The medical treatment facility shall submit one set of documents including the report on the application of the pilot project of the special category technique as per the provisions of this point and the proposed technical procedure by the medical treatment facility;

- Within ten working days from receipt of a complete set of documents, the Ministry of Health shall conduct an inspection to verify the results of the pilot project and the proposed technical procedures submitted by the medical treatment facility;

- Within five working days from the issuance of the inspection report on the results of the pilot project and the technical procedure, the Ministry of Health shall decide to permit the medical treatment facility to implement the special category technique officially. In case of disagreement, a written response with reasons must be provided;

- The medical treatment facility shall follow the procedures from Clause 1 to Clause 9 of this Article for the addition of the officially approved special category technique into its scope of professional activities.

d) For cases where no pilot project is required, the following steps are to be taken:

- Within five working days, the Ministry of Health shall issue a decision permitting the medical treatment facility to implement the special category technique without conducting a pilot project. In case of disagreement, a written response with reasons must be provided;

Article 5. Implementation

1. The Ministry of Health shall be responsible for monitoring, urging, and inspecting the implementation of this Resolution.

2. The Minister, Heads of agencies at the same level as ministries, Chairmen of People's Committees of provinces and municipalities shall bear responsibility for implementing this Resolution.

3. People's Councils, committees of People's Councils, deputies to People's Councils, and Vietnam Fatherland Front at all levels shall strengthen supervision over the implementation of this Resolution within their scope of duties and authority.

4. Heads of agencies, units, civil servants, public officials who participated in drafting and promulgating this Resolution may be exempted or have their responsibilities reduced according to the provisions of Clause 11, Article 68 of the Law on Issuing Normative Legal Documents No. 64/2025/QH15 as amended by Law No. 87/2025/QH15.

Article 6. Effective Date

1. This Resolution shall be effective from April 29, 2026 to January 1, 2028, except as provided in Clauses 2 and 3 of this Article.

2. The provisions of Clause 2 of this Resolution shall come into effect on July 1, 2026.

3. The provisions of Clause 3 and Clause 1 of Clause 4 of this Resolution shall come into effect on July 1, 2027.

4. During the period when this Resolution is effective, if laws, resolutions of the National Assembly, ordinances, or decisions of the Standing Committee of the National Assembly, decrees, or decisions of the Government have provisions concerning administrative procedures related to the provisions in this Resolution and are adopted or promulgated, then the corresponding provisions in this Resolution shall cease to be effective at the time those normative legal documents come into effect.

5. For applications for handling administrative procedures in fields specified in Clauses 2, 3, and 4 of this Resolution and the annexed appendix that have been received by competent authorities or stamped with postal seals before the effective date of this Resolution, they shall be handled according to the provisions of the current laws regulating such matters at the time of receipt.

6. During the period when the provisions in this Resolution are effective, if administrative procedures and business conditions in this Resolution differ from relevant normative legal documents within the authority of the Government and the Prime Minister, then they shall be implemented according to the provisions in this Resolution.