The Vietnamese MOH has released the proposed amendment at the end of 2019 to the Vietnamese medical device industry while waiting for the documents to be officialized.
These will further amend the Decree No. 169/2018/ND-CP ("Decree No. 169") and Decree No. 36/2016/ND-CP relating to the management of medical devices ("Decree No. 36").
The last amendment targeted effective on 1 January 2020, maybe further extended to 1 January 2021 for Class B and 1 January 2022 for Class C and D.
Here are some proposed amendments released to the Vietnamese industry:
Extension for the validity of import permit and registration circulation number issued before 01 Jan 2020:
Imported medical equipment has been granted an import license before December 31, 2019, and does not fall into the cases specified in Clause 1, Article 42 and Point (e) of this Clause:
If the license was granted in 2018 and expires on December 31, 2018, it will continue to be used until the end of December 31, 2021;
If the license is granted in 2019, it is valid until the end of December 31, 2021.
In-vitro diagnostic products that have been issued with an import license and the import license expires from January 1, 2018, to December 31, 2019, may continue to use the import license until the end December 31, 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 January 1, 2018, to December 31, 2019, the circulation numbers will continue to be used until the end of December 31, 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 January 1, 2021;
The circulation number of imported medical equipment of Class C and D takes effect from January 1, 2022.
Application for import license for in-vitro diagnostic medical equipment being reagents, calibrators and in vitro control materials from January 1, 2020 to December 31, 2021:
Current and in past, all imported by the license under circular 44/2011 and quotation permit under circular 47
Advertising of medical equipment:
Article related to medical equipment in decree 181/2013 is revised and will go effective in 2021.
Now and time till Jan 2021, advertising materials still have to follow circular 09/2015, which will be submitted for approval in a tool that DMEC is preparing.
Reference: MOH draft announcement