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02 YEARS OF EXTENSION FOR IMPORT LICENSE OF CLASS B, C, D MEDICAL DEVICES

On January 01, 2020, the Government promulgates the Decree No. 03/2020/ND-CP on amending and supplementing Article 68 of the Decree No. 36/2016/ND-CP dated May 25, 2016 of Government on medical devices management which is amended and supplemented in the Decree No. 169/2018/ND-CP dated December 31, 20128 of the Government on amending and supplementing the Government’s Decree No. 36/2016/ND-CP on medical devices management.

Accordingly, the Government amends a number of regulations on import license of medical devices. To be specific: Import license for class B, C, D medical devices and in vitro diagnostic reagents granted in 2018, 2019, 2020, 2021 shall hold effectiveness until December 31, 2021 instead of expired in January 01, 2020 as regulated before.

In addition, medical devices that not on the list of goods subject to import licensing and have been classified as class B, C or D by a classifying organization and posted on the website of the Ministry of Health shall be allowed to be imported until the end of December 31, 2021 instead of December 31, 2019 as before. Those devices shall be imported as necessity without quantity limitation and exempt from Ministry of Health’s confirmation when carry out customs clearance procedures.

This Decree takes effect on the signing date.

 

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