Vietnam: Temporary Freezing of the Online System for Submission of Class C and D Medical Devices by the Ministry of Health
On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices. The DMEC website is currently under maintenance starting 01 January 2024 in order to implement the CSDT in accordance with Decree 07/2023/NĐ-CP amending some articles of Decree 98/2021/NĐ-CP dated 08 November 2023 regarding ‘Medical Device Management’. Changes will also be applied to the government fee in accordance with Circular 59/2023/TT-BTC regarding ‘Prescribing Fee in the Medical Sector, and Collection, Transfer, Management, and Use Thereof’.
Currently, all recent submission applications for class C and D medical devices are already temporarily frozen. Medical device companies shall wait until the system is ready for use again in order to pay the government fee.
Please kindly note that with regard to the temporary freezing of the online system, the Authority did not provide an official announcement.
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