On 3 March 2023, Decree 07/2023 ‘Amendments To Government’s Decree No. 98/2021/Nd-Cp Dated November 08, 2021 Prescribing Medical Device Management, 2019’ was signed by the Ministry of Health (MoH) of Vietnam.
The Decree states that Class C and D Medical Devices, not listed in Circular 05/2022, can be freely imported into the country. It also introduces changes to the regulatory requirements for In Vitro Diagnostic (IVD) Medical Devices.
Decree 07/2023 is effective immediately and amends the previous Decree 98/2022, which came into force on 1 January 2022.
Specifically, the Vietnamese Ministry of Health issued Decree 07/2023 to address the high number of applications for registration of Class C and D Devices, providing for the following time frame:
– extension until 31 December 2024 of import licence validity for Class C and D Medical Devices listed in Circular 05/2022;
– indefinite extension of Market Authorization (MA) for Class C and D devices;
– Class C and D Medical Devices not listed Circular 05/2022 are not affected by the extension.
The decree also introduces significant requirements that impact the placing of devices on the market in Vietnam, in particular:
– Medical Devices without the import licence requirement may be imported until 31 December 2024 provided the importer declares the classification of the Medical Device on the Department of Medical Equipment and Construction (DMEC) online portal;
– as of 1 January 2024, the Common Submission Dossier Template (CSDT) replaces the Technical Dossier, IFUs, Labelling, ERC and Brochure and must be written in Vietnamese;
– dossiers must be approved within three amendment cycles requested by the MoH (one cycle = 90 days);
– from 1 July 2023, manufacturers and those who market certain Medical Devices must publish the price of certain Medical Devices on DMEC;
– Class A and B devices are supervised by the provincial offices of the MoH, so that the MoH can focus on applications for Class C and D devices;
– import licences issued to IVD products between 1 January 2018 and 31 December 2018 can continue to be used until 31 December 2024.
The measure, by which the Vietnamese government decided to extend the validity of import licences until 31 December 2024, aims to address the shortage of Class C and D devices and in vitro diagnostic Medical Devices in certain regions of the state, thus preserving the import of those devices that are essential to safeguard patients’ lives.
To stay up-to-date with updates on the regulation of Medical Devices and IVDs for Vietnamese market access, subscribe to our Newsletter.
>> Through our strategic regulatory consulting services and support for ministerial registration in Vietnam, Thema can help you comply with Vietnamese regulatory requirements.
Contact us for information.