Decree No. 148/2025/NĐ-CP on Delegation and Decentralization in the Health Sector

DECREE
Regulations on Delegation and Decentralization in the Health Sector
                

Pursuant to the Law on Government Organization 2025;

Pursuant to the Law on Local Government Organization 2025;

Pursuant to Resolution No. 190/2025/QH15 dated February 19, 2025 of the National Assembly on handling certain issues related to the restructuring of the state apparatus;

At the proposal of the Minister of Health;

The Government promulgates this Decree to regulate delegation and decentralization in the health sector.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree stipulates the authority, procedures, and formalities for implementing tasks and powers of agencies and authorized individuals in the health sector as prescribed by laws, resolutions of the National Assembly, ordinances, resolutions of the Standing Committee of the National Assembly, decrees of the Government, and decisions of the Prime Minister, which need adjustment to implement delegation and decentralization.

Article 2. Principles of Authority Division

1. Ensuring compliance with the Constitution; aligning with principles and regulations on delegation and decentralization under the Law on the Organization of the Government 2025 and the Law on the Organization of Local Administration 2025.

2. Ensuring thorough decentralization of tasks between central government agencies and local authorities, ensuring the unified management authority of the Government and the operational authority of the head of the Government over the national administration of the Ministry of Justice, while promoting the initiative, creativity, and accountability of local authorities in performing national administrative management tasks in the judicial field.

3. Ensuring that the Government, the Prime Minister, Ministries, and ministerial-level agencies focus on macro-level state management tasks; building coherent and unified systems, strategies, plans, playing a constructive role, and strengthening inspection, supervision, and monitoring.

4. Promoting delegation and decentralization, clearly defining the authority of People's Councils, People's Committees, and heads of specialized health agencies under People's Committees; clearly distinguishing the general authority of People's Committees from the specific authority of heads of specialized health agencies under People's Committees; ensuring alignment with the responsibilities, powers, and capabilities of agencies and authorized individuals assigned such tasks.

5. Implementing delegation and decentralization among related sectors and fields in a coordinated, comprehensive, interconnected manner, without omission or overlap of tasks; ensuring a legal basis for the normal, continuous, and smooth operation of agencies; preventing work interruptions, overlapping, duplication, or omission of functions, tasks, areas, or regions.

6. Ensuring human rights and citizens' rights; ensuring transparency and creating favorable conditions for individuals and organizations to access information, exercise their rights and obligations, and follow legal procedures; not affecting the normal activities of society, citizens, and businesses.

7. Ensuring no impact on the implementation of international treaties and agreements to which the Socialist Republic of Vietnam is a party.

Article 3. Fees and Charges

When handling administrative procedures requiring payment of fees and charges as prescribed by laws on fees and charges, individuals and organizations must simultaneously submit the application for administrative procedures and pay the fees and charges to the agency receiving the application. The amount of fees and charges, their management, and utilization shall be implemented according to the provisions of the Government, the Minister of Finance, or the People's Council at the provincial level for corresponding fees and charges.

Chapter II
DELEGATION IN THE HEALTH SECTOR

Article 4. Appointment of forensic medical examiners and forensic psychiatric examiners

1. The appointment of forensic medical examiners and forensic psychiatric examiners as prescribed in Clause 1 and Clause 2, Article 9 of the 2012 Legal Appraisal Law amended and supplemented in 2020 shall be within the authority of the head of the specialized agency on health under the provincial People's Committee.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions of Part 1 of Appendix I issued together with this Decree.

Article 5. Removal of forensic medical examiners and forensic psychiatric examiners

1. The removal of forensic medical examiners and forensic psychiatric examiners as prescribed in Article 10 of the 2012 Legal Appraisal Law amended and supplemented in 2020 shall be within the authority of the head of the specialized agency on health under the provincial People's Committee.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions of Part 2 of Appendix I issued together with this Decree.

Article 6. Adjustment of permits for medical examination and treatment activities

1. The adjustment of permits for medical examination and treatment activities in cases of changes in scale of operations, scope of professional activities, or addition or reduction of technical categories (excluding special technical categories) for private hospitals as prescribed in Clause 13, Article 121 of the Medical Examination and Treatment Law shall be within the authority of the head of the specialized agency on health under the provincial People's Committee.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions of Part 1 of Appendix II issued together with this Decree.

Article 7. Issuance, reissuance, extension, adjustment, suspension, and revocation of permits for medical examination and treatment activities

1. The issuance, reissuance, extension, adjustment, suspension, and revocation of permits for medical examination and treatment activities for the subjects prescribed in Point a, Clause 1, Article 28 of the Medical Examination and Treatment Law shall be within the authority of the head of the specialized agency on health under the provincial People's Committee.

2. Documents, procedures, and steps:

a) Issuance of new permits for medical practice shall be carried out in accordance with the provisions of Part 2 of Appendix II issued together with this Decree;

b) Reissuance of permits for medical practice shall be carried out in accordance with the provisions of Part 3 of Appendix II issued together with this Decree;

c) Extension of permits for medical practice shall be carried out in accordance with the provisions of Part 4 of Appendix II issued together with this Decree;

d) Adjustment of permits for medical practice shall be carried out in accordance with the provisions of Part 5 of Appendix II issued together with this Decree;

đ) Suspension of medical practice shall be carried out in accordance with the provisions of Part 6 of Appendix II issued together with this Decree;

e) Revocation of permits for medical practice shall be carried out in accordance with the provisions of Part 7 of Appendix II issued together with this Decree.

Chapter III
CLASSIFICATION IN THE HEALTH SECTOR

Section 1

CLASSIFICATION UNDER THE PREVENTION FIELD

Article 8. Issuance of Certificates of Occupational Exposure to HIV and Certificates of Occupational Infection with HIV

1. The issuance of Certificates of Occupational Exposure to HIV and Certificates of Occupational Infection with HIV as prescribed in Clause 1, Article 4 of Decision No. 24/2023/QĐ-TTg dated September 22, 2023 of the Government Chairman regarding conditions for determining persons exposed to HIV and persons infected with HIV due to occupational accidents and risks working at agencies under the Ministry of Health located in the province shall be within the authority of the head of the specialized agency on health under the provincial People's Committee.

2. Dossier, procedures, and formalities for issuance:

a) Certificate of Occupational Exposure to HIV shall be carried out in accordance with the provisions of Part 1 of Appendix III issued together with this Decree;

b) Certificate of Occupational Infection with HIV shall be carried out in accordance with the provisions of Part 2 of Appendix III issued together with this Decree.

Article 9. Issuance of Certificate for Testing Facilities Meeting Biosafety Level III Standards

1. The issuance of new and renewed certificates for testing facilities meeting biosafety level III standards as stipulated in Clause 1, Article 10 of Decree No. 103/2016/NĐ-CP dated July 1, 2016 of the Government on ensuring biosafety in laboratories falls within the authority of the head of the specialized health administration body under the provincial People's Committee.

2. Dossier, procedures, and formalities for issuance:

a) The issuance of new certificates for testing facilities meeting biosafety level III standards shall be carried out in accordance with the provisions set forth in Part 3 of Appendix III promulgated together with this Decree;

b) The renewal of certificates for testing facilities meeting biosafety level III standards upon expiration shall be carried out in accordance with the provisions set forth in Part 4 of Appendix III promulgated together with this Decree;

c) The renewal of certificates for testing facilities meeting biosafety level III standards due to damage or loss shall be carried out in accordance with the provisions set forth in Part 5 of Appendix III promulgated together with this Decree;

d) The renewal of certificates for testing facilities meeting biosafety level III standards due to a change in the facility name shall be carried out in accordance with the provisions set forth in Part 6 of Appendix III promulgated together with this Decree.

Article 10. Issuance of Certificate for Facilities Meeting Conditions to Conduct Confirmatory HIV Positive Tests

1. The issuance of new, renewed, amended, and revoked certificates for facilities meeting conditions to conduct confirmatory HIV positive tests as stipulated in Clause 1, Article 42 of Decree No. 141/2024/NĐ-CP dated October 28, 2024 of the Government detailing certain provisions of the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV/AIDS) falls within the authority of the head of the specialized health administration body under the provincial People's Committee.

2. Dossier, procedures, and formalities for issuance:

a) The issuance of new certificates for facilities meeting conditions to conduct confirmatory HIV positive tests shall be carried out in accordance with the provisions set forth in Part 7 of Appendix III promulgated together with this Decree;

b) The renewal of certificates for facilities meeting conditions to conduct confirmatory HIV positive tests shall be carried out in accordance with the provisions set forth in Part 8 of Appendix III promulgated together with this Decree;

c) The amendment of certificates for facilities meeting conditions to conduct confirmatory HIV positive tests shall be carried out in accordance with the provisions set forth in Part 9 of Appendix III promulgated together with this Decree.

Article 11. Documents, Procedures, and Formalities for Announcing Compliance with Conditions for Conducting Occupational Environmental Monitoring

1. The acceptance of documents for announcing compliance with conditions for conducting occupational environmental monitoring as stipulated in Point a, Clause 2, Article 34 of Decree No. 44/2016/NĐ-CP dated May 15, 2016 of the Government detailing certain provisions of the Labor Safety and Health Law on technical safety and health inspection activities, safety and health training, and occupational environmental monitoring for organizations proposing to announce compliance with conditions for conducting occupational environmental monitoring with their headquarters located within the province falls within the authority of the head of the specialized health administration body under the provincial People's Committee.

2. The documents, procedures, and formalities for announcing compliance with conditions for conducting occupational environmental monitoring shall be carried out in accordance with the provisions set forth in Part 10 of Appendix III promulgated together with this Decree.

Article 12. Documents, procedures, and formalities for registering the circulation of insecticides and disinfectants used in household and medical fields

1. The issuance of new registrations, reissuance, extension, supplementation, revocation of registration for circulation, and import permits for insecticides and disinfectants used in household and medical fields, as stipulated in Decree No. 91/2016/NĐ-CP dated July 1, 2016 of the Government on the management of chemicals, insecticides, and disinfectants used in household and medical fields (amended and supplemented in 2024), shall be within the authority of the head of the specialized health agency under the provincial People's Committee.

2. Documents, procedures, and steps:

a) New registration for the circulation of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 11 of Appendix III issued together with this Decree;

b) Extension of registration numbers for the circulation of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 12 of Appendix III issued together with this Decree;

c) Supplementary registration due to changes in ownership of the registration number for insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 13 of Appendix III issued together with this Decree;

d) Supplementary registration due to renaming of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 14 of Appendix III issued together with this Decree;

đ) Supplementary registration due to changes in the production location or production facility of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 15 of Appendix III issued together with this Decree;

e) Supplementary registration due to changes in the name or contact address of the registration entity or production entity of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 16 of Appendix III issued together with this Decree;

g) Supplementary registration due to changes in the efficacy, dosage, usage method, active ingredient content, synergist additive content, formulation type, shelf life, source of active ingredients of insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 17 of Appendix III issued together with this Decree;

h) Reissue of the certificate of registration for circulation for insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 18 of Appendix III issued together with this Decree;

i) Notification of changes in the content and form of labels for insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 19 of Appendix III issued together with this Decree;

k) Issuance of import permits for insecticides and disinfectants used in household and medical fields imported for research purposes shall be carried out in accordance with the provisions of Part 20 of Appendix III issued together with this Decree;

1) Issuance of import permits for insecticides and disinfectants used in household and medical fields for aid purposes shall be carried out in accordance with the provisions of Part 21 of Appendix III issued together with this Decree;

m) Issuance of import permits for insecticides and disinfectants used in household and medical fields that are gifts, donations, or presents shall be carried out in accordance with the provisions of Part 22 of Appendix III issued together with this Decree;

n) Issuance of import permits for insecticides and disinfectants used in household and medical fields when there is no suitable product or usage method available on the market to meet the needs of the importing organization or individual shall be carried out in accordance with the provisions of Part 23 of Appendix III issued together with this Decree;

o) Issuance of certificates of free circulation (CFS) for insecticides and disinfectants used in household and medical fields exported under the jurisdiction of the Ministry of Health shall be carried out in accordance with the provisions of Part 24 of Appendix III issued together with this Decree;

p) Amendment, supplementation, and reissuance of certificates of free circulation (CFS) for insecticides and disinfectants used in household and medical fields exported under the jurisdiction of the Ministry of Health shall be carried out in accordance with the provisions of Part 25 of Appendix III issued together with this Decree;

q) Suspension of circulation and revocation of registration numbers for insecticides and disinfectants used in household and medical fields shall be carried out in accordance with the provisions of Part 26 of Appendix III issued together with this Decree.

Section 2
CLASSIFICATION UNDER THE FIELD OF MEDICAL EXAMINATION AND TREATMENT

Article 13. Acceptance of announcement of eligibility to conduct health examinations and HIV/AIDS diagnosis and treatment

1. The acceptance of announcement of eligibility to conduct health examinations and HIV/AIDS diagnosis and treatment as stipulated in point a, Clause 1, Article 69 of Decree No. 96/2023/NĐ-CP dated December 30, 2023, detailing certain provisions of the Law on Medical Examination and Treatment shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 8 of Appendix II issued together with this Decree.

Article 14. Permitting foreigners to enter Vietnam to transfer medical technology or cooperate in medical training involving practical medical examination and treatment

1. The permitting of foreigners to enter Vietnam to transfer medical technology or cooperate in medical training involving practical medical examination and treatment as stipulated in point a, Clause 3, Article 86 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 9 of Appendix II issued together with this Decree.

Article 15. Permitting organizations to operate charitable medical examination and treatment activities in batches or mobile medical examination and treatment

1. The permitting of organizations to operate charitable medical examination and treatment activities in batches or mobile medical examination and treatment as stipulated in Clause 1, Article 79 of the Law on Medical Examination and Treatment or individuals conducting charitable medical examination and treatment as stipulated in point a, Clause 3, Article 83 of Decree No. 96/2023/NĐ-CP (excluding charitable medical examination and treatment in batches or mobile medical examination and treatment in two or more centrally governed cities or provinces) shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 10 of Appendix II issued together with this Decree.

Article 16. Acceptance of announcement of medical examination and treatment facilities meeting requirements for practical training bases

1. The acceptance of announcement of medical examination and treatment facilities meeting requirements for practical training bases as stipulated in point a, Clause 2, Article 6 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 11 of Appendix II issued together with this Decree.

Article 17. Acceptance of announcement of medical examination and treatment facilities meeting conditions for remote medical examination and treatment

1. The acceptance of announcement of medical examination and treatment facilities meeting conditions for remote medical examination and treatment as stipulated in point a, Clause 3, Article 87 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 12 of Appendix II issued together with this Decree.

Article 18. Permitting medical examination and treatment facilities to pilot remote medical examination and treatment

1. The permitting of medical examination and treatment facilities to pilot remote medical examination and treatment as stipulated in point a, Clause 6, Article 87 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the People's Committee at the provincial level.

2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with the provisions in Part 13 of Appendix II issued together with this Decree.

Article 19. Registration for Professional Practice

Clause 1. The acceptance of registration for professional practice as stipulated in Article 29 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Clause 2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with Part 14 of Appendix II attached to this Decree.

Section 3
CLASSIFICATION IN THE FIELD OF MEDICAL DEVICES

Article 20. Continued Circulation of Medical Devices When the Owner Ceases Production or Goes Bankrupt

Clause 1. The continued circulation of medical devices when the owner ceases production or goes bankrupt, as provided for in Article 37 of Decree No. 98/2021/NĐ-CP dated November 8, 2021, amended and supplemented in 2025, shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Clause 2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with Part 1 of Appendix IV attached to this Decree.

Article 21. Issuance of Free Circulation Certificates for Medical Devices

Clause 1. The issuance of free circulation certificates (CFS) for medical devices of Class A and B as stipulated in Clause 1 of Article 50 of Decree No. 98/2021/NĐ-CP, amended and supplemented in 2025, shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Clause 2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with Part 2 of Appendix IV attached to this Decree.

Article 22. Acceptance of Declaration of Concentration and Content in Raw Materials for Manufacturing Medical Devices Containing Narcotics and Precursors

Clause 1. The acceptance of declarations regarding the concentration and content of narcotics and precursors as stipulated in Clause 2 of Article 60 and the acceptance of reports on the purchase, export, import, and transfer of medical devices, raw materials for manufacturing, and external reagents containing narcotics and precursors as stipulated in Clause 4 of Article 74 of Decree No. 98/2021/NĐ-CP, amended and supplemented in 2025, shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Clause 2. The dossier, procedures, and formalities for accepting declarations regarding the concentration and content of narcotics and precursors shall be carried out in accordance with Part 3 of Appendix IV attached to this Decree.

Article 23. Withdrawal of Classification Results for Medical Devices

Clause 1. The head of the specialized agency under the provincial People's Committee responsible for health matters shall be responsible for implementing the withdrawal of classification results for medical devices as stipulated in Article 6 of Decree No. 98/2021/NĐ-CP, amended and supplemented in 2025.

Clause 2. The dossier, procedures, and formalities for implementation shall be carried out in accordance with Part 4 of Appendix IV attached to this Decree.

Article 24. Declaration of Prices for Medical Devices

Clause 1. The acceptance of price declaration documents for medical devices as stipulated in Sub-item 15 of Appendix V attached to Decree No. 85/2024/NĐ-CP dated July 10, 2024, detailing certain provisions of the Price Law, shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Clause 2. The issuance of the list of organizations engaged in the business of medical devices that declare prices, the method of accepting and declaring prices for medical devices shall be carried out in accordance with Part 5 of Appendix IV attached to this Decree, and shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

Section 4

CLASSIFICATION IN THE FIELD OF FOOD SAFETY DRUGS

Article 25. Issuance, amendment, supplementation, reissuance of Free Circulation Certificates (CFS) for food products

1. The issuance, amendment, supplementation, and reissuance of Free Circulation Certificates (CFS) for export food products under the management of the Ministry of Health as stipulated in Article 11 of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Foreign Trade Management shall be within the authority of the head of the specialized health agency under the provincial People's Committee or the specialized agency assigned tasks by the provincial People's Committee.

2. Documents, procedures, and steps:

a) The issuance of Free Circulation Certificates (CFS) for export food products under the management of the Ministry of Health shall be carried out in accordance with the provisions of Part 1 of Appendix V promulgated together with this Decree;

b) The amendment, supplementation, and reissuance of Free Circulation Certificates (CFS) for export food products under the management of the Ministry of Health shall be carried out in accordance with the provisions of Part 2 of Appendix V promulgated together with this Decree.

Article 26. Registration of Advertising Content for Food Products

1. The acceptance of registration of advertising content for medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old as stipulated in Clause 2 of Article 26 of Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government detailing certain provisions of the Food Safety Law shall be within the authority of the head of the specialized health agency under the provincial People's Committee or the specialized agency assigned tasks by the provincial People's Committee.

2. The dossier, procedures, and processes shall be implemented in accordance with the provisions of Part 3 of Appendix V promulgated together with this Decree.

Article 27. Issuance of Food Safety Condition Certificate

1. The issuance of Food Safety Condition Certificates for food production establishments under the management of the Ministry of Health as stipulated in Chapter III of Decree No. 67/2016/ND-CP dated July 1, 2016 of the Government on conditions for food production and business activities under the specialized management of the Ministry of Health, which has been amended and supplemented in 2018, shall be within the authority of the head of the specialized health agency under the provincial People's Committee or the specialized agency assigned tasks by the provincial People's Committee.

2. The dossier, procedures, and processes shall be implemented in accordance with the provisions of Part 4 of Appendix V promulgated together with this Decree.

Article 28. Registration of Product Declaration for Medical Nutrition Foods, Special Diet Foods, and Nutritional Products for Children Up to 36 Months Old

1. The acceptance of registration of product declarations for imported products and domestically produced products for medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old as stipulated in Clause 1 of Article 8 of Decree No. 15/2018/ND-CP shall be within the authority of the head of the specialized health agency under the provincial People's Committee or the specialized agency assigned tasks by the provincial People's Committee.

2. Documents, procedures, and steps:

a) The registration of product declarations for imported medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old shall be carried out in accordance with the provisions of Part 5 of Appendix V promulgated together with this Decree;

b) The registration of product declarations for domestically produced medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old shall be carried out in accordance with the provisions of Part 6 of Appendix V promulgated together with this Decree.

Article 29. Designation of food testing facilities for state management

1. The designation of food testing facilities for state management as stipulated in Clause 6, Article 37 of Decree No. 15/2018/NĐ-CP shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters or the specialized agency assigned tasks by the provincial People's Committee.

2. Documents, procedures, and steps:

a) The designation of food testing facilities for state management shall be carried out in accordance with the provisions of Part 7 of Appendix V issued together with this Decree;

b) The designation of food testing facilities that have been evaluated and certified according to National Standard TCVN ISO/IEC 17025 or International Standard ISO/IEC 17025 by a legally recognized organization in Vietnam or an international organization participating in mutual recognition agreements of the International Laboratory Accreditation Cooperation, Asia-Pacific Laboratory Accreditation Cooperation shall be carried out in accordance with the provisions of Part 8 of Appendix V issued together with this Decree;

c) Any changes or additions to the scope of designation of food testing facilities for state management shall be carried out in accordance with the provisions of Part 9 of Appendix V issued together with this Decree;

d) The extension of the designation of food testing facilities for state management shall be carried out in accordance with the provisions of Part 10 of Appendix V issued together with this Decree;

đ) The exemption from supervision for food testing facilities that have been evaluated and certified according to National Standard TCVN ISO/IEC 17025 or International Standard ISO/IEC 17025 by a legally recognized organization in Vietnam or an international organization participating in mutual recognition agreements of the International Laboratory Accreditation Cooperation, Asia-Pacific Laboratory Accreditation Cooperation shall be carried out in accordance with the provisions of Part 11 of Appendix V issued together with this Decree.

Article 30. Issuance of certificates for exported foods

1. The issuance of certificates for exported foods (including export food certificates and health certificates) as stipulated in Article 42 of the Food Safety Law and Clause 5, Article 37 of Decree No. 15/2018/NĐ-CP shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters or the specialized agency assigned tasks by the provincial People's Committee.

2. The dossier and procedures for issuing certificates for exported foods shall be carried out in accordance with the provisions of Part 12 of Appendix V issued together with this Decree.

Article 31. Assignment or designation of state inspection agencies for imported food safety for products under the jurisdiction of the Ministry of Health

The assignment or designation of state inspection agencies for imported food safety for products under the jurisdiction of the Ministry of Health as stipulated in Clause 1, Article 15 and Clause 1, Article 37 of Decree No. 15/2018/NĐ-CP shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters or the specialized agency assigned tasks by the provincial People's Committee.

Section 5
CLASSIFICATION UNDER THE FIELD OF MATERNAL AND CHILD HEALTH AND THE FIELD OF SCIENCE, TECHNOLOGY AND TRAINING

Article 32. Recognition of medical establishments conducting in vitro fertilization techniques

1. The recognition of medical establishments conducting in vitro fertilization techniques as stipulated in Article 8 of Decree No. 10/2015/NĐ-CP dated January 28, 2015 of the Government on in vitro fertilization techniques and conditions for surrogacy for humanitarian purposes, amended and supplemented in 2016 and 2018 shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

2. The dossier, procedure, and process for recognizing medical establishments conducting in vitro fertilization techniques shall be carried out in accordance with the provisions of Part 1 of Appendix VI issued together with this Decree.

Article 33. Issuing Certificates for Educational Institutions Meeting Conditions to Conduct and Recognize Proficiency in Vietnamese or Other Languages or Adequate Interpretation Level in Medical Examination and Treatment

1. The issuance of certificates for educational institutions meeting conditions to conduct and recognize proficiency in Vietnamese or other languages or adequate interpretation level in medical examination and treatment as stipulated in Clause 3, Article 141 of Decree No. 96/2023/NĐ-CP shall be within the authority of the head of the specialized agency under the provincial People's Committee responsible for health matters.

2. The dossier, procedures, and formalities shall be carried out in accordance with Appendix VI attached to this Decree.

Chapter IV IMPLEMENTATION PROVISIONS

Article 34. Effective Date

1. This Decree takes effect from July 1, 2025.

2. Abolish the procedures prescribed in Appendix VIII attached to this Decree from the date this Decree takes effect.

3. This Decree shall cease to be effective from March 1, 2027 except for the following cases:

a) Ministries and ministerial-level agencies report to the Government to propose and obtain the National Assembly's decision to extend the application period of this Decree in whole or in part;

b) Where laws, resolutions of the National Assembly, ordinances, resolutions of the Standing Committee of the National Assembly, decrees, resolutions of the Government, decisions of the Prime Minister provide for state management authorities, responsibilities, procedures as stipulated in this Decree and are adopted or issued from July 1, 2025 and take effect before March 1, 2027, then the corresponding provisions in this Decree shall become ineffective at the time these legal documents come into force.

4. During the period when the provisions of this Decree are effective, if the provisions on state management authorities, responsibilities, procedures in this Decree differ from those in related legal documents, they shall be implemented according to the provisions of this Decree.

Article 35. Transitional Provisions

For dossiers submitted before this Decree takes effect: The agency receiving the dossiers shall continue to process them according to current regulations until the administrative procedure is completed.

Appendix I
FIELD OF FORENSIC APPRAISAL

(Passed by the Government on June 12, 2025)

Part 1. Dossier and Procedures for Appointing Forensic Appraisers and Forensic Mental Health Appraisers

1. Dossier for appointing forensic appraisers and forensic mental health appraisers:

a) A proposal for appointing forensic appraisers and forensic mental health appraisers from the competent authority;

b) A copy of the bachelor’s degree or higher diploma relevant to the proposed field of expertise;

Diplomas issued by foreign educational institutions must be recognized for use in Vietnam according to agreements, mutual recognition arrangements regarding diplomas, or international treaties related to diplomas that the Socialist Republic of Vietnam has signed.

c) Curriculum vitae as prescribed;

d) Certificate from the organization or institution where the proposed appointee works, confirming their actual professional experience;

đ) Training or refresher course certificate for judicial appraisal in the fields of forensic science, forensic psychiatry, and criminal technical investigation for those proposed to be appointed as judicial appraisers.

2. Procedures for appointing forensic appraisers and forensic mental health appraisers:

a) The Institute of Criminal Science - Ministry of Public Security; Military Forensic Institute - Ministry of National Defense; National Forensic Institute; Central Forensic Psychiatry Institute; Central Forensic Psychiatry Institute in Bien Hoa; five regional forensic psychiatry centers; forensic appraisal organizations shall examine, select, complete, and submit the dossier to the specialized health agency under the provincial People's Committee where the headquarters is located (hereinafter referred to as the dossier receiving agency).

b) The dossier receiving agency shall be responsible for receiving and checking the validity of the dossier. In case the dossier is incomplete, the dossier receiving agency shall issue a document guiding the unit or individual to complete the dossier.

c) Within twenty days from the date of receipt of a valid dossier, the dossier receiving agency shall organize the review of the dossier proposing the appointment of forensic appraisers and forensic mental health appraisers, and submit it to the head of the dossier receiving agency for consideration and decision on the appointment of forensic appraisers and forensic mental health appraisers.

If the appointment is not made, the dossier receiving agency must issue a document explaining the reasons.

d) Within ten days from the date of appointment of forensic appraisers and forensic mental health appraisers, the dossier receiving agency shall be responsible for establishing and posting the list of appointed forensic appraisers and forensic mental health appraisers on the provincial People's Committee's electronic portal, and send it to the Ministry of Justice to establish a comprehensive list of judicial appraisers.

Part 2. Documents and Procedures for Removing Forensic Medical Examiners and Forensic Mental Health Examiners

1. Documents for Removing Forensic Medical Examiners and Forensic Mental Health Examiners:

a) A proposal document for removing forensic medical examiners and forensic mental health examiners from the managing agency or organization, or a resignation letter from the forensic medical examiner or forensic mental health examiner;

b) Documentation proving that the forensic medical examiner or forensic mental health examiner falls under one of the circumstances subject to removal.

2. Procedure for Removing Forensic Medical Examiners and Forensic Mental Health Examiners:

a) The Institute of Criminal Science - Ministry of Public Security; Military Forensic Institute - Ministry of National Defense; National Forensic Institute; Central Forensic Mental Health Institute; Central Forensic Mental Health Institute Bien Hoa; Five Regional Forensic Mental Health Centers; forensic examination organizations shall prepare removal documents and submit them to the receiving agency.

b) The receiving agency is responsible for checking the legality of the documents. In cases where the documents are incomplete or invalid, the People's Committee of the province shall issue guidance to complete the documents.

Within 10 days from the date of receipt of complete and valid documents, the receiving agency shall present the matter to the head of the receiving agency for consideration and decision on removal, revocation of the forensic medical examiner or forensic mental health examiner card, and adjustment of the list of examiners on the provincial People's Committee's electronic information portal, while sending the Ministry of Justice to adjust the general list of judicial examiners.

If the removal is not approved, the receiving agency shall notify the proposing agency in writing and specify the reasons.

Seal Registration Certificate
ADMINISTRATIVE PROCEDURES IN THE FIELD OF
MEDICAL EXAMINATION AND TREATMENT
(Attached to Decree No. 148/2025/NĐ-CP dated June 12, 2025 of the Government)

Part 1. Procedures and Formalities for Adjusting Medical Practice Licenses for Private Hospitals in Cases of Changes in Scale of Operations, Scope of Professional Activities, or Addition or Reduction of Technical Item Categories (excluding special technical item categories)

1. Submit one set of documents as prescribed in Clause 2, Article 64 of Decree No. 96/2023/NĐ-CP (directly, through postal service, or via electronic environment) and pay the fee as prescribed by laws on fees and charges to the specialized agency on health under the Provincial People's Committee (hereinafter referred to as the receiving agency).

2. After receiving the documents, the receiving agency shall issue a receipt to the requesting entity.

3. In case of requests for amendments or supplements to the documents, within seven working days from the date recorded on the receipt, the receiving agency must send a written notice to the requesting entity specifying the required documents and contents to be amended or supplemented.

Within six months from the date the receiving agency issues a notice for amendment or supplementation, the requesting entity must submit the amended or supplemented documents as requested. Beyond this period, if the requesting entity does not amend or supplement the documents, the submitted documents will lose their validity.

4. After receiving the amended or supplemented documents, the receiving agency shall issue a receipt for the amended or supplemented documents to the requesting entity.

If the amended or supplemented documents do not meet the requirements, the receiving agency must notify the requesting entity in writing according to Clause 3 of this Article.

Within six months from the date the receiving agency issues a notice for amendment or supplementation, the requesting entity must submit the amended or supplemented documents as requested.

Beyond this period, if the requesting entity does not amend or supplement the documents, or if within twelve months from the date of the initial submission, the supplementary documents do not meet the requirements, the submitted documents will lose their validity.

5. In cases where there are no requests for amendments or supplements to the documents or the documents have been completed as prescribed in Clauses 3 and 4 of this Article, the receiving agency:

a) Shall issue a document permitting changes in scale of operations, scope of professional activities, or addition or reduction of technical item categories within twenty days from the date recorded on the receipt, if it does not require on-site verification at the facility;

b) The receiving agency shall organize on-site verification at the requesting facility and prepare a verification report within sixty days from the date recorded on the receipt, for cases requiring on-site verification, the report must specify any required amendments or supplements (if any).

6. After on-site verification, the receiving agency shall be responsible for:

a) Issuing a document permitting changes in scale of operations, scope of professional activities, or addition or reduction of technical item categories within ten working days from the date of issuing the verification report, if there are no requests for amendments or supplements;

b) Issuing a notice regarding the necessary corrections or improvements within five working days from the date of issuing the verification report, if there are requests for amendments or supplements.

Within six months from the date the receiving agency issues a notice regarding necessary amendments or supplements, if the requesting entity fails to complete these tasks, the submitted documents will lose their validity.

7. Within ten working days from the date of receipt of the notification document and proof of completion of amendments or supplements from the requesting entity, the receiving agency:

a) Shall issue a document permitting changes in scale of operations, scope of professional activities, or addition or reduction of technical item categories for cases where on-site verification of amendments or supplements is not required;

b) Shall conduct on-site verification of amendments or supplements in cases where on-site verification is required:

Issue a document permitting changes in scale of operations, scope of professional activities, or addition or reduction of technical item categories if the requesting entity has completed the amendments or supplements;

Issue a response document specifying the reasons for not permitting changes in scale of operations, scope of professional activities, or addition or reduction of technical item categories if the requesting entity has completed the amendments or supplements.

8. Within five working days from the date of permission to adjust the business operation permit, the agency receiving the registration dossier shall publish and update on its electronic portal or website, and on the Information System for Managing Medical Examination and Treatment Activities, all relevant information related to the adjustment content.

9. The document granting permission to adjust the business operation permit shall be prepared in two copies: one copy issued to the requesting entity and one copy retained by the issuing authority, except in cases where the result has been delivered electronically.