Process of receiving, appraising, issuing, post-checking and revoking medical device circulation numbers

The process is built to unify regulations to carry out procedures for receiving, evaluating, approving applications for granting or refusing to issue, post-checking and revoking medical equipment circulation numbers according to the provisions of 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 amended Change and supplement a number of articles of Decree No. 98/2021/ND-CP (Decree No. 07/2023/ND-CP).

Content includes processes:
– Approving dossiers requesting issuance of new circulation numbers for medical device with corresponding national technical regulations, medical device that is a measuring device must have its sample approved according to the provisions of law on measurement medical device in urgent cases, medical device in urgent cases and other medical device.

– After checking the documents, there is a circulation number for medical devices of types C and D in cases of quick and emergency issuance.

– Revoke the circulation number.

Download details here:

https://dmec.moh.gov.vn/documents/10182/48796040/1.QD3714-ISO-cap-luu-hanh.signed.pdf/835884f2-6b1a-48df-862f-83cdb09df353