Decentralize the performance of a number of tasks and the settlement of a number of administrative procedures in the field of medical equipment under the authority of the Ministry of Health to the Department of Infrastructure and Medical Equipment.
According to the Circular, the delegation of performance of a number of tasks and settlement of a number of administrative procedures in the field of medical equipment under the authority of the Ministry of Health to the Department of Infrastructure and Medical Equipment:
1. Granting new circulation numbers for medical devices of type C and D according to the provisions of Article 32 and Article 32a of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
2. Inspection after granting circulation number for medical devices of type C, D according to regulations in Clause 3 and Clause 4, Article 32 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
3. Suspend circulation of a batch of medical equipment, terminate the suspension of circulation of a batch of medical equipment according to the provisions of Clause 3, Article 34 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
4. Recall the batch of medical equipment according to the provisions of Clause 4, Article 34 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
5. Issue a document on whether or not to allow continued circulation of medical equipment according to the provisions of Article 37 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
6. Revoke the medical device circulation number according to the provisions of Article 39 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
7. Granting of medical equipment import licenses according to the provisions of Article 48 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
8. Granting, re-granting and revoking certificates of free circulation of medical equipment according to the provisions of Article 50 of Decree No. 98/2021/ND-CP amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
9. Granting new, supplementing and revoking certificates of registration for medical equipment inspection activities according to the provisions of Article 56 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
10. Decide on the handling of medical equipment that fails to meet inspection requirements as prescribed in Article 58 of Decree No. 98/2021/ND-CP as amended and supplemented by Decree No. 07/2023/ND-CP, Decree No. 96/2023/ND-CP and Decree No. 04/2025/ND-CP.
11. Specialized inspection of organizations and individuals performing the following activities: medical equipment classification; production, circulation, purchase, sale, export, import, and provision of medical equipment services; information and advertising of medical equipment; management and use of medical equipment at medical facilities as prescribed in Clause 1, Article 6 of Decree No. 217/2025/ND-CP.
This Circular takes effect from November 22, 2025. Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health stipulating the form of documents and reports on the implementation of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical equipment management, amended and supplemented by Circular No. 10/2023/TT-BYT, ceases to be effective from the effective date of this Circular.
For dossiers submitted to the management agency before the effective date of this Circular using the forms prescribed in Circular No. 19/2021/TT-BYT amended and supplemented by Circular No. 10/2023/TT-BYT: If such documents and reports expire or require amendments or supplements, organizations and individuals must follow the form issued with this Circular when updating, amending or supplementing the dossier.
The Authorization Letter and Certificate of eligibility for medical equipment warranty signed and issued by the owner of the medical equipment according to the form prescribed in Circular No. 19/2021/TT-BYT, amended and supplemented by Circular No. 10/2023/TT-BYT before the effective date of this Circular and still in effect, shall continue to be used.
Minh Hien
Source: https://baochinhphu.vn/phan-cap-giai-quyet-mot-so-thu-tuc-hanh-chinh-linh-vuc-thiet-bi-y-te-102251124161227521.htm
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