Amendments on Decree 169

December 4, 2019

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:

  • Imported medical equipment has been granted an import license before 31 December 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 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

following documents:

  •  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.

 

 

 

 

 

 

 

 

 

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