Proposal to decentralize the implementation of medical equipment management tasks under the authority of the Ministry of Health

(Chinhphu.vn) - The Ministry of Health is seeking public opinions on the draft Circular regulating the decentralization of medical equipment management tasks under the authority of the Ministry of Health.

Decentralize the implementation of a number of tasks and settlement of administrative procedures in the field of medical equipment under the management authority of the Ministry of Health to the Department of Infrastructure and Medical Equipment.

The draft Circular proposes regulations applicable to agencies, organizations and individuals involved in activities in the field of medical equipment: Classification of medical equipment; production, circulation, purchase, sale, export, import, provision of medical equipment services; information and advertising of medical equipment; management and use of medical equipment at medical facilities.

Decentralization of task performance and handling of administrative procedures in the field of medical equipment to the Department of Infrastructure and Medical Equipment

According to the draft, the implementation of a number of tasks and handling of administrative procedures in the field of medical equipment under the management authority of the Ministry of Health is decentralized to the Department of Infrastructure and Medical Equipment:

1- Carry out a number of tasks assigned by the Ministry of Health in Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management (Decree No. 98/2021/ND-CP), Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government amending and supplementing a number of articles of Decree No. 98/2021/ND-CP (Decree No. 07/2023/ND-CP), 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 (Decree No. 96/2023/ND-CP), Decree No. 107/2016/ND-CP dated July 1, 2016 of the Government Decree No. 107/2016/ND-CP and Decree No. 42/2025/ND-CP dated February 27, 2025 of the Government regulating the functions, tasks, powers and organizational structure of the Ministry of Health, including:

a) New issuance and post-inspection of circulation numbers for medical devices of type C and D according to regulations in Article 32 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP;

b) Revoke the circulation number of medical devices of type C and D according to the provisions of Article 39 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP;

c) Suspend circulation of a batch of medical equipment, terminate the suspension of circulation of a batch of medical equipment, and recall a batch of medical equipment according to the provisions of Article 34 of Decree No. 98/2021/ND-CP;

c) Continue or refuse to allow the circulation of medical devices of type C and D according to the provisions of Article 37 of Decree No. 98/2021/ND-CP;

d) Granting of medical equipment import licenses according to regulations in Article 48 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP;

d) Issue new and revoke certificates of free circulation for medical devices of type C and D according to the provisions of Articles 49 and 50 of Decree No. 98/2021/ND-CP;

e) Issue new, supplement, and amend certificates of registration for medical equipment inspection activities according to regulations in Article 12 of Decree No. 107/2016/ND-CP;

g) Revoke the certificate of registration for medical equipment inspection activities as prescribed in Article 26 of Decree No. 107/2016/ND-CP;

h) Consider priority cases for processing medical device registration dossiers according to regulations in Clause 21, Article 147 of Decree No. 96/2023/ND-CP.

2- Carry out specialized inspection tasks for organizations and individuals performing medical equipment classification activities; manufacturing, circulating, purchasing, selling, exporting, importing, and providing medical equipment services; providing information and advertising medical equipment; managing and using medical equipment at medical facilities according to regulations in Clause 1, Article 6 of Decree No. 217/2025/ND-CP dated August 5, 2025 of the Government on specialized inspection activities.

The Ministry of Health is seeking comments on this draft on the Ministry's Information Portal.

Minh Hien

Source: https://baochinhphu.vn/de-xuat-phan-cap-thuc-hien-nhiem-vu-quan-ly-thiet-bi-y-te-thuoc-tham-quyen-cua-bo-y-te-102251006151522464.htm