On 31 December 2018, the Vietnamese government issued Decree No. 169/2018/ND-CP ("Decree No. 169") amending and supplementing certain provisions of Decree No. 36/2016/ND-CP relating to the management of medical devices ("Decree No. 36"). The Decree 169 took place immediately after its issuance. Here are some notable amendments:
Extension for the valid of import permit and registration circulation number that issued before 1 Jan 2020:
If the license was granted in 2018 and expires on 31 December 2018, it will continue to be used until the end of 31 December 2021;
If the license is granted in 2019, it is valid until the end of 31 December 2021.
In-vitro diagnostic products that have been issued with an import license and the import license expires from 1 January 2018 to 31 December 2019, may continue to use the import license until the end 31 December 2021.
If the diagnostic product of in-vitro has been issued with a circulation number, the circulation number will be valid until the end of the time stated in the certificate of registration of circulation.
If the circulation numbers expire from 1 January 2018 to 31 December 2019, the circulation numbers will continue to be used until the end of 31 December 2021.
Propose a new effective date for product license under Decree 36 & 169 as below:
The circulation of imported medical equipment that falls into Class B is effective from 1 January 2021;
The circulation number of imported medical equipment of Class C and D takes effect from 1 January 2022.
Application processes to import license for in-vitro diagnostic medical equipment being
reagents, calibrators and in vitro control materials from 1 January 2020 to 31 December 2021:
Note: Current and in past, all imported by the license under circular 44/2011 and quotation permit under circular 47
The contents of advertisements for medical equipment must conform to one of the
Dossier of announcement of standards applicable to medical equipment of category A;
Registration dossier for circulation of medical equipment of types B, C and D;
Advertising of medical equipment must have the following contents:
Name of the medical equipment, manufacturer, and country of manufacture of the medical equipment;
Features, effects, instructions for use, storage conditions (if any).
Note: Now and time till Jan 2021, advertising materials still have to follow circular 09/2015, which will be submit for approval in a tool that DMEC is preparing and go effective maybe from Nov 2019.