February 17, 2020
VN MOH released the Decree 03/2020, to amend Decree 36 & 169, which is effective from Jan 1, 2020. Below are remarks relating to the imported Medical Device as below: (Qualtech marks up the different place comparing to Decree 36 & 169 in red for your reference.)
- For class Amedical device, there is a receipt note for applicable standard declaration issued by the Department of Health, which is imported according to demand without quantity restriction and without the confirmation letter from MOH to confirm it is medical device prior customs declaration procedures.
- For medical devices excluded in the list of goods of Circular 30 that classified as class B, C, and D medical device by the organizations which was published into the electronic portal by MOH will continue to be imported until December 31, 2021 on demand, without any quantity restriction and confirmation letter from MOH.
- Class B, C and D medical devices that are specifically listed out in Circular 30 must be applied Import Permit until Dec 31, 2021 and the Import License will be effective until Dec 31, 2021.
- Import licenses for class B, C and D medical device expired on December 31, 2018 or Dec 31, 2019 are valid automatically until December 31, 2021.
- MOH began to receive registration application for all class B, C, and D imported medical devices from July 1, 2017 and the registration number for class B, C, D will be valid from Jan 1, 2022.
- CSDT will take effects from Jan 1st 2020.