Decree 148/2025/ND-CP delegation and decentralization of authority in the health sector

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Decree No. 148/2025/ND-CP dated June 12, 2025 of the Government providing for delegation and decentralization of authority in the health sector
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Official number: 148/2025/ND-CP Signer: Nguyen Hoa Binh
Type: Decree Expiry date:
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Issuing date: 12/06/2025 Effect status:
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Fields: Administration , Medical - Health , Organizational structure
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 THE GOVERNMENT

___________

 

No. 148/2025/ND-CP

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

___________________

Hanoi, June 12, 2025

 

 

DECREE

Providing for delegation and decentralization of authority in the health sector

 

Pursuant to the 2025 Law on Organization of the Government;

Pursuant to the 2025 Law on Organization of Local Administration;

Pursuant to the Resolution No. 190/2025/QH15 dated February 19, 2025, of the National Assembly stipulating the handling of matters related to the reorganization of the state apparatus;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree providing for delegation and decentralization of authority in the health sector.

 

Chapter I

GENERAL PROVISIONS

 

Article 1. Scope of regulation

This Decree stipulates the authority, order, and procedures for performing the tasks and powers of agencies and competent persons in the health sector as prescribed in 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 that need to be adjusted for the implementation of delegation and decentralization of authority.

Article 2. Principles of determination of competence

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

2. Ensure thorough decentralization of tasks between central state agencies and local administrations; ensure unified management competence of the Government, the executive competence of the Head of the Government over the state management field of the Ministry of Justice, and promote the initiative, creativity and accountability of local administrations in performing state management tasks in the judicial field.

3. Ensure that the Government, the Prime Minister, the Ministries, and ministerial-level agencies focus on performing macro-level state management tasks; formulate institutional frameworks, strategies, planning, and unified and synchronous plans; play a constructive role and strengthen inspection, examination, and supervision.

4. Promote decentralization and delegation and clearly define the competence of the People's Councils, the People's Committees, and the heads of specialized health agencies under the People's Committees; clearly determine the general competence of the People's Committees from the specific competence of the heads of specialized health agencies under the People's Committees; ensure alignment with the tasks, powers, and capacities of the agencies and competent persons responsible for performing the delegated tasks and powers.

5. Implement the delegation and decentralization of powers across relevant sectors and fields in a manner that ensures consistency, comprehensiveness, interoperability, without omissions, overlaps, or duplication of tasks; ensure a legal basis for the normal, continuous, and smooth operation of agencies; avoid work disruption, overlapping, duplication, omission of functions, tasks, sectors, and localities.

6. Ensure human rights and citizens’ rights; ensure transparency and publicity, creating favorable conditions for individuals and organizations in accessing information, exercising rights and obligations, and carrying out procedures as prescribed by law; without adversely affecting the normal operations of society, the people, and enterprises.

7. Ensure that the enforcement of international treaties and agreements to which the Socialist Republic of Vietnam is a contracting party is not affected.

Article 3. Charges and fees

For administrative procedures that require the payment of charges and fees in accordance with the law on charges and fees, the individuals and organizations shall pay the applicable charges and fees to the receiving agency at the time of submitting their application for the resolution of the administrative procedure. The charge and fee rates, as well as the management and use of charges and fees, shall comply with the regulations of the Government, the Minister of Finance, or the provincial-level People's Councils, corresponding to each type of charge or fee.

 

Chapter II

DELEGATION OF AUTHORITY IN THE HEALTH SECTOR

 

Article 4. Appointment of forensic expert assessors and psychiatrically forensic expert assessors

1. The appointment of forensic expert assessors and psychiatrically forensic expert assessors as prescribed in Clauses 1 and 2, Article 9 of the 2012 Law on Judicial Assessment, as amended and supplemented in 2020, falls under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 1 of Appendix I issued together with this Decree.

Article 5. Relief from duty of forensic expert assessors and psychiatrically forensic expert assessors

1. The relief from duty of forensic expert assessors and psychiatrically forensic expert assessors as prescribed in Article 10 of the 2012 Law on Judicial Assessment, as amended and supplemented in 2020, falls under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 2 of Appendix I issued together with this Decree.

Article 6. Modification of licenses for medical examination and treatment activities

1. The modification of licenses for medical examination and treatment activities in cases involving changes in the scale of operations, scope of professional activities, or addition or reduction of the list of techniques (excluding the list of special techniques) for private hospitals, as stipulated in Clause 13, Article 121 of the Law on Medical Examination and Treatment, falls under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 1 of Appendix II issued together with this Decree.

Article 7. Grant, re-grant, extension, modification, suspension, and revocation of license to practice medical examination and treatment

1. The grant, re-grant, extension, modification, suspension, and revocation of licenses to practice medical examination and treatment for the subjects specified at Point a, Clause 1, Article 28 of the Law on Medical Examination and Treatment fall under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures for:

a) The grant of practicing licenses shall be implemented in accordance with Part 2 of Appendix II issued together with this Decree;

b) The re-grant of practicing licenses shall be implemented in accordance with Part 3 of Appendix II issued together with this Decree;

c) The extension of practicing licenses shall be implemented in accordance with Part 4 of Appendix II issued together with this Decree;

d) The modification of practicing licenses shall be implemented in accordance with Part 5 of Appendix II issued together with this Decree;

dd) The suspension from practice shall be implemented in accordance with Part 6 of Appendix II issued together with this Decree;

e) The revocation of practicing licenses shall be implemented in accordance with Part 7 of Appendix II issued together with this Decree.

 

Chapter III
DECENTRALIZATION IN THE HEALTH SECTOR

 

Section 1
DECENTRALIZATION IN THE FIELD OF DISEASE PREVENTION

 

Article 8. Grant of the certificates of HIV exposure due to occupational accidents and risks and the certificates of HIV infection due to occupational accidents and risks

1. The grant of the certificates of HIV exposure due to occupational accidents and risks and the certificates of HIV infection due to occupational accidents and risks as stipulated in Clause 1, Article 4 of the Decision No. 24/2023/QD-TTg dated September 22, 2023, of the Prime Minister, providing for the conditions for identifying persons exposed to HIV and persons infected with HIV due to occupational accidents and risks, for persons working at the establishments under the Ministry of Health located within the province, falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures for:

a) For certificates of HIV exposure due to occupational accidents and risks, to comply with Part 1 of Appendix III issued together with this Decree;

b) For certificates of HIV infection due to occupational accidents and risks, to comply with Part 2 of Appendix III issued together with this Decree.

Article 9. Grant of certificates of satisfaction of level-III biosafety standards for testing laboratories

1. The grant and re-grant of the certificates of satisfaction of level-III biosafety standards for testing laboratories as stipulated in Clause 1, Article 10 of the Decree No. 103/2016/ND-CP dated July 1, 2016, of the Government on biosafety in laboratories, falls under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures for:

a) The grant of certificates of satisfaction of level-III biosafety standards for testing laboratories, to comply with Part 3 of Appendix III issued together with this Decree;

b) The re-grant of certificates of satisfaction of level-III biosafety standards for testing laboratories due to expiration, to comply with Part 4 of Appendix III issued together with this Decree;

c) The re-grant of certificates of satisfaction of level-III biosafety standards for testing laboratories due to damage or loss, to comply with Part 5 of Appendix III issued together with this Decree;

d) The re-grant of certificates of satisfaction of level-III biosafety standards for testing laboratories due to change of the name of the testing, to comply with Part 6 of Appendix III issued together with this Decree.

Article 10. Grant of certificates of eligibility for conducting HIV positive confirmatory tests for testing laboratories

1. The grant, re-grant, modification, and revocation of certificates of eligibility for conducting HIV positive confirmatory tests for testing laboratories as stipulated in Clause 1, Article 42 of the Decree No. 141/2024/ND-CP dated October 28, 2024, of the Government detailing a number of articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS), shall fall under the competence of the head of the specialized health agency under the provincial-level People's Committee.

2. The dossier, order, and procedures for:

a) The re-grant of certificates of eligibility for conducting HIV positive confirmatory tests for testing laboratories shall comply with Part 7 of Appendix III issued together with this Decree;

b) The re-grant of certificates of eligibility for conducting HIV positive confirmatory tests for testing laboratories shall comply with Part 8 of Appendix III issued together with this Decree;

c) The modification of certificates of eligibility for conducting HIV positive confirmatory tests for testing laboratories shall comply with Part 9 of Appendix III issued together with this Decree.

Article 11. Dossier, order, and procedures for announcement of eligibility for working environment monitoring

1. The receipt of dossiers for the declaration of eligibility for working environment monitoring, as stipulated at Point a, Clause 2, Article 34 of the Decree No. 44/2016/NĐ-CP dated May 15, 2016, of the Government detailing the implementation of several articles of the Law on Occupational Safety and Health regarding technical inspection of occupational safety, training in occupational safety and health, and working environment monitoring, for institutions requesting announcement of eligibility for working environment monitoring that are headquartered within the province, falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures for announcement of eligibility for working environment monitoring shall be implemented in accordance with Part 10 of Appendix III issued together with this Decree.

Article 12. Dossier, order, and procedures for circulation registration for insecticidal or germicidal preparations for household and medical use

1. The grant, re-grant, extension, supplementation, revocation of circulation registrations, and the grant of import permits for insecticidal or germicidal preparations for household and medical use as stipulated in the Decree No. 91/2016/ND-CP dated July 1, 2016, of the Government on management of insecticidal or germicidal chemicals and preparations for household and medical use, as amended and supplemented in 2024, falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures for:

a) The new circulation registration for insecticidal or germicidal preparations for household and medical use shall comply with Part 11 of Appendix III issued together with this Decree;

b) The extension of circulation registration numbers for insecticidal or germicidal preparations for household and medical use shall comply with Part 12 of Appendix III issued together with this Decree;

c) The supplementary circulation registration due to changes in ownership of circulation registration numbers for insecticidal or germicidal preparations for household and medical use shall comply with Part 13 of Appendix III issued together with this Decree;

d) The supplementary circulation registration due to changes in the names of insecticidal or germicidal preparations for household and medical use shall comply with Part 14 of Appendix III issued together with this Decree;

dd) The supplementary circulation registration due to relocation of the production establishment or change of the production establishment of insecticidal or germicidal preparations used in household and medical sectors shall comply with Part 15, Appendix III issued together with this Decree;

e) The supplementary circulation registration due to change of the name and address of the registering establishment, of the production establishment of insecticidal or germicidal preparations used in household and medical sectors shall comply with Part 16, Appendix III issued together with this Decree;

g) The supplementary circulation registration due to change in effects, dosage, usage methods, active ingredient content, synergistic additive content, formulation type, expiration date, or source of active ingredients shall comply with Part 17, Appendix III issued together with this Decree;

h) The registration for re-grant of the Certificate of Circulation Registration for insecticidal or germicidal preparations used in household and medical sectors shall comply with Part 18, Appendix III issued together with this Decree;

i) Notification of changes in the content or design of labels for insecticidal or germicidal preparations used in household and medical sectors shall comply with Part 19, Appendix III issued together with this Decree;

k) The grant of import permits for insecticidal or germicidal preparations used in household and medical sectors for research purposes shall comply with Part 20, Appendix III issued together with this Decree;

l) The grant of import permits for insecticidal or germicidal preparations used in household and medical sectors for humanitarian aid purposes shall be implemented in accordance with Part 21, Appendix III issued together with this Decree.

m) The grant of import permits for insecticidal or germicidal preparations for household and medical use as gifts or donations shall be implemented in accordance with Part 22, Appendix III issued together with this Decree;

n) The grant of import permits for insecticidal or germicidal preparations for household and medical use in case products or use methods needed by organizations and individuals applying for an import license are unavailable on the market shall be implemented in accordance with Part 23, Appendix III issued together with this Decree;

o) The grant of certificates of free sale (CFS) for insecticidal or germicidal preparations for household and medical use for export under the management of the Ministry of Health shall be implemented in accordance with Part 24, Appendix III issued together with this Decree;

p) The amendment, supplementation, or re-grant of certificates of free sale (CFS) for insecticidal or germicidal preparations for household and medical use for export under the management of the Ministry of Health shall be implemented in accordance with Part 25, Appendix III issued together with this Decree;

q) The suspension of circulation or revocation of the circulation registration number for insecticidal or germicidal preparations for household and medical use shall be implemented in accordance with Part 26, Appendix III issued together with this Decree.

 

Section 2

DECENTRALIZATION IN THE FIELD OF MEDICAL EXAMINATION AND TREATMENT

 

Article 13. Receipt of the declaration of the eligibility to perform health check-ups or examination and treatment of HIV/AIDS

1. The receipt of the declaration of the eligibility to perform health check-ups or examination and treatment of HIV/AIDS as stipulated at Point a, Clause 1, Article 69 of the Decree No. 96/2023/ND-CP dated December 30, 2023 of the Government detailing a number of articles of the Law on Medical Examination and Treatment shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 8 of Appendix II issued together with this Decree.

Article 14. Permission for foreigners to enter Vietnam and transfer of professional techniques in medical examination and treatment or cooperation in medical training involving medical examination and treatment internship

1. The permission for foreigners to enter Vietnam and transfer of professional techniques in medical examination and treatment or cooperation in medical training involving medical examination and treatment internship, as stipulated at Point a, Clause 3, Article 86 of Decree No. 96/2023/ND-CP, falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 9 of Appendix II issued together with this Decree.

Article 15. Permission to organize humanitarian medical examination and treatment under campaigns, mobile medical examination and treatment activities

1. The permission to organize humanitarian medical examination and treatment under campaigns, mobile medical examination and treatment activities as specified in Clause 1, Article 79 of the Law on Medical Examination and Treatment, or for individuals conducting humanitarian medical examination and treatment as stipulated at Point a, Clause 3, Article 83 of the Decree No. 96/2023/ND-CP (excluding humanitarian medical examination and treatment under campaigns or on a mobile basis in two or more centrally-run provinces or cities) shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 10 of Appendix II issued together with this Decree.

Article 16. Receipt of the declaration of medical examination and treatment establishments meeting the requirements for serving as internship-instructing establishment

1. The receipt of the declaration of medical examination and treatment establishments meeting the requirements for serving as internship-instructing establishment as stipulated at Point a, Clause 2, Article 6 of the Decree No. 96/2023/ND-CP shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 11 of Appendix II issued together with this Decree.

Article 17. Receipt of the declaration of medical examination and treatment establishments eligible to provide telehealth

1. The receipt of the declaration of medical examination and treatment establishments eligible to provide telehealth as stipulated at Point a, Clause 3, Article 87 of the Decree No. 96/2023/ND-CP shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 12 of Appendix II issued together with this Decree.

Article 18. Permission for medical examination and treatment establishments to pilot application of telehealth

1. The permission for medical examination and treatment establishments to pilot application of telehealth as stipulated at Point a, Clause 6, Article 87 of the Decree No. 96/2023/ND-CP shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 13 of Appendix II issued together with this Decree.

Article 19. Practice registration

1. The receipt of practice registration as stipulated in Article 29 of the Decree No. 96/2023/ND-CP shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 14 of Appendix II issued together with this Decree.

 

Section 3
DECENTRALIZATION IN THE FIELD OF MEDICAL DEVICES

 

Article 20. Continuation of circulation of medical devices in cases where the owner of medical devices discontinues production or undergoes bankruptcy or dissolution, applicable to type-A and type-B medical devices

1. The continuation of circulation of medical devices in cases where the owner of medical devices discontinues production or undergoes bankruptcy or dissolution, applicable to type-A and type-B medical devices as stipulated in Article 37 of the Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government, as amended and supplemented in 2025, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 1 of Appendix IV issued together with this Decree.

Article 21. Grant of certificate of free sale for medical devices

1. The grant of Certificate of Free Sale (CFS) for type-A and type-B medical devices as stipulated in Clause 1, Article 50 of the Decree No. 98/2021/ND-CP, as amended and supplemented in 2025, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 2 of Appendix IV issued together with this Decree.

Article 22. Receipt of the declaration of concentration and content in raw materials used for manufacturing medical devices and external quality control substances containing narcotic substances and precursors

1. The receipt of the declaration of concentration and content of narcotic substances and precursors as stipulated in Clause 2, Article 60, and the receipt of reports on trading, exporting, importing, and transferring medical devices, manufacturing raw materials, and external quality control substances containing narcotic substances and precursors as stipulated in Clause 4, Article 74 of the Decree No. 98/2021/ND-CP, as amended and supplemented in 2025, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, order, and procedures for the receipt of the declaration of concentration and content of narcotic substances and precursors shall be implemented in accordance with Section 3, Appendix IV issued together with this Decree.

Article 23. Revocation of medical device classification results

1. The head of the specialized health agency under the provincial-level People’s Committee shall be responsible for revoking the classification results of medical devices as stipulated in Article 6 of the Decree No. 98/2021/ND-CP, as amended and supplemented in 2025.

2. The dossier, order, and procedures shall be implemented in accordance with Part 4 of Appendix IV issued together with this Decree.

Article 24. Declaration of medical device prices

1. The receipt of the declaration of medical device prices as stipulated in Subsection 15, Appendix V issued together with the Decree No. 85/2024/ND-CP dated July 10, 2024 of the Government detailing a number of articles of the Law on Price shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The grant of the List of medical device trading organizations required to declare prices, the method of receipt, and the implementation of medical device price declarations in accordance with Section 5, Appendix IV issued together with this Decree, and shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

 

Section 4

DECENTRALIZATION IN THE FIELD OF FOOD SAFETY

 

Article 25. Grant, modification, supplementation, and re-grant of the certificate of free sale (CFS) for food products

1. The grant, modification, supplementation, and re-grant of the certificate of free sale (CFS) for food products for export under the management competence of the Ministry of Health as stipulated in Article 11 of the Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing a number of articles of the Law on Foreign Trade Management shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee or the specialized agency assigned by the provincial-level People’s Committee.

2. The dossier, order, and procedures for:

a) The grant of the certificate of free sale (CFS) for food products for export under the management competence of the Ministry of Health shall be implemented in accordance with Section 1, Appendix V issued together with this Decree;

b) The modification, supplementation, and re-grant of the certificate of free sale (CFS) for food products for export under the management competence of the Ministry of Health shall be implemented in accordance with Section 2, Appendix V issued together with this Decree.

Article 26. Registration of food advertisement content

1. The receipt of registration of food advertisement content concerning medical foods, food for special dietary uses and dietary products for children up to 36 months as stipulated in Clause 2, Article 26 of the Decree No. 15/2018/ND-CP dated February 02, 2018 of the Government detailing the implementation of a number of articles of the Law on Food Safety shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee or the specialized agency assigned by the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 3 of Appendix V issued together with this Decree.

Article 27. Grant of certificate of food safety

1. The grant of certificates of food safety to food production establishments under the authority of the Ministry of Health as stipulated in Chapter III of the Decree No. 67/2016/ND-CP dated July 01, 2016 of the Government on conditions for food production and trading under the specialized management of the Ministry of Health, as amended and supplemented in 2018, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee or the specialized agency assigned by the provincial-level People’s Committee.

2. The dossier, order, and procedures shall be implemented in accordance with Part 4 of Appendix V issued together with this Decree.

Article 28. Registration of product declaration for medical foods, food for special dietary uses and dietary products for children up to 36 months old

1. The receipt of registration of product declarations for imported products and domestically produced products concerning medical foods, food for special dietary uses and dietary products for children up to 36 months old as stipulated in Clause 1, Article 8 of the Decree No. 15/2018/ND-CP shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee or the specialized agency assigned by the provincial-level People’s Committee.

2. The dossier, order, and procedures for:

a) The registration of product declarations for imported medical foods, food for special dietary uses and dietary products for children up to 36 months old shall be implemented in accordance with Part 5, Appendix V issued together with this Decree.

b) The registration of product declarations for domestically produced medical foods, food for special dietary uses and dietary products for children up to 36 months old shall be implemented in accordance with Part 6, Appendix V issued together with this Decree.

Article 29. Designation of laboratories to test foods for state management purposes

1. The designation of laboratories to test foods for state management purposes as stipulated in Clause 6, Article 37 of the Decree No. 15/2018/ND-CP falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee or the specialized agency assigned by the provincial-level People’s Committee.

2. The dossier, order, and procedures for:

a) The designation of laboratories to test foods for state management purposes shall be implemented in accordance with Part 7, Appendix V issued together with this Decree.

b) The designation of food testing laboratories that have been accredited by a legally recognized organization in Vietnam or by a foreign accreditation organization that is a member of mutual recognition agreements of the International Laboratory Accreditation Cooperation (ILAC) or the Asia Pacific Accreditation Cooperation (APAC), and that have been assessed and certified in compliance with National Standard TCVN ISO/IEC 17025 or International Standard ISO/IEC 17025, shall be implemented in accordance with Part 8, Appendix V.

c) The amendment or supplementation of the scope of designation of laboratories to test foods for state management purposes shall be implemented in accordance with Part 9, Appendix V.

d) The extension of designation of laboratories to test foods for state management purposes shall be implemented in accordance with Part 10, Appendix V.

dd) The exemption from supervision and inspection for food testing laboratories that have been accredited by a legally recognized organization in Vietnam or by a foreign accreditation organization that is a member of mutual recognition agreements of the International Laboratory Accreditation Cooperation (ILAC) or the Asia Pacific Accreditation Cooperation (APAC), and that have been assessed and certified in compliance with National Standard TCVN ISO/IEC 17025 or International Standard ISO/IEC 17025, shall be implemented in accordance with Part 11, Appendix V issued together with this Decree.

Article 30. Grant of certificates for exported food products

1. The grant of certificates for exported food products (including certificates of exported food and health certificates) as stipulated in Article 42 of the Law on Food Safety and Clause 5, Article 37 of the Decree No. 15/2018/ND-CP falls under the competence of the head of the specialized health agency under the provincial-level People’s Committee, or a specialized agency assigned by the provincial-level People’s Committee.

2. The dossier and procedures for the grant of certificates for exported food products shall be implemented in accordance with Part 12, Appendix V issued together with this Decree.

Article 31. Assignment or designation of agencies to perform state inspection of food safety of imported products under the assigned management of the Ministry of Health

The assignment or designation of agencies to perform state inspection of food safety of imported products under the assigned management of the Ministry of Health, as stipulated in Clause 1, Article 15 and Clause 1, Article 37 of the Decree No. 15/2018/ND-CP, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee, or the specialized agency assigned by the provincial-level People’s Committee.

 

Section 5

DECENTRALIZATION IN THE FIELDS OF MATERNAL AND CHILD HEALTH AND SCIENCE, TECHNOLOGY, AND TRAINING

 

Article 32. Recognition of medical examination and treatment establishments eligible to perform in vitro fertilization

1. The recognition of medical examination and treatment establishments eligible to perform in vitro fertilization as stipulated in Article 8 of the Decree No. 10/2015/ND-CP dated January 28, 2015 of the Government on giving birth through in vitro fertilization and conditions for altruistic gestational surrogacy, as amended in 2016 and 2018 shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, process, and procedures for recognition of medical examination and treatment establishments eligible to perform in vitro fertilization shall be implemented according to Part 1, Appendix VI issued together with this Decree.

Article 33. Grant of certificates of education institutions eligible for conducting testing and recognition of persons who are proficient in Vietnamese or other languages or qualified for interpretation in medical examination and treatment

1. The grant of certificates of education institutions eligible for conducting testing and recognition of persons who are proficient in Vietnamese or other languages or qualified for interpretation in medical examination and treatment as specified in Clause 3, Article 141 of the Decree No. 96/2023/ND-CP, shall fall under the competence of the head of the specialized health agency under the provincial-level People’s Committee.

2. The dossier, procedures, and process shall be implemented in accordance with Appendix VI issued together with this Decree.

 

Chapter IV
IMPLEMENTATION PROVISIONS

 

Article 34. Effect

1. This Decree shall take effect from July 1, 2025.

2. The procedures stipulated in Appendix VIII issued together with this Decree shall be annulled as from the effective date of this Decree.

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

a) The ministries or ministerial-level agencies report to the Government and are approved by the National Assembly to extend the effect of all or part of this Decree;

b) The laws, resolutions of the National Assembly, ordinances, resolutions of the National Assembly Standing Committee, decrees, resolutions of the Government, or decisions of the Prime Minister, which provide for state management competence, responsibilities, procedures, or processes as stipulated in this Decree, are enacted or issued from July 1, 2025 and come into force before March 1, 2027, then the corresponding provisions of this Decree shall cease to be effective at the time such legal documents come into effect.

4. During the effective period of this Decree, in case of any discrepancy regarding state management competence, responsibilities, procedures, or processes between this Decree and other relevant legal normative documents, the provisions of this Decree shall prevail.

Article 35. Transitional provisions

For dossiers submitted before the effective date of this Decree, the competent authority receiving the dossiers shall continue to process them in accordance with the current regulations until the administrative procedures are completed.

 

FOR THE GOVERNMENT

FOR THE PRIME MINISTER

THE DEPUTY PRIME MINISTER

 

 

 

  

 

Nguyen Hoa Binh

 

* All Appendices are not translated herein.

 

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