Vietnamese Regulators Amend Medical Device Registration Requirements

By Megan Gottlieb and Hugh Nguyen

The Vietnamese government  has issued an amendment to the regulation on medical device registration.

Decree No. 07/2023 (link in Vietnamese) amends Decree No. 98/2021 to extend certain transitional arrangements for higher-risk Class C and D devices, and makes a number of other changes to the regulatory requirements for medical devices and in vitro diagnostic (IVD) devices.

Notable changes to Vietnamese regulatory requirements include:

• Extension of transitional provisions for certain Class C and D devices, in which:
  • Import Licenses issued for medical devices and IVDs from January 1, 2018 to December 31, 2021 under the prior regulatory regime will remain valid through the end of 2024
  • Devices that were exempted from the Import License requirement under the prior regulatory regime may be imported without registration through the end of 2024, as long as the importer declares a Classification Result for the device in the online portal of the Department of Medical Equipment and Construction (DMEC)
  • All devices that were subject to the Import License requirement under the prior regulatory regime but do not have a valid Import License require a Market Authorization Code (MAC) in accordance with the requirements of Decree No. 98/2021, as amended by Decree No. 07/2023, for import and sale in Vietnam
  • The Common Submission Dossier Template (CSDT) format will not be required for Class C and D device registration (MAC) applications until January 1, 2024, and until then, the requirements defined in Article 76(6) of Decree No. 98/2021, as amended by Decree No. 07/2023, will apply for the registration dossier
• MACs issued for IVDs from January 1, 2014 to December 31, 2019 will remain valid through the end of 2024, and those issued in 2020 or 2021 may be used until the expiration date indicated on the registration certificate
• Applicants must address requests from the Vietnamese Ministry of Health (MoH) within three rounds of review (previously five rounds), or the application may be cancelled; the time allowed for each round remains 90 days
• The Marketing Authorization Holder (MAH) is no longer required to declare the sales pricing policy for devices, and this is instead under the responsibility of the distributor(s)
• The MoH will publish a list of companies that have submitted false information for medical device registration

Megan Gottlieb is Senior Program Service Specialist, Regulatory Services at Emergo by UL and Hugh Nguyen is Chairman at MedNovum Canada.