The medical device sector in Vietnam has been the focus of significant regulatory reform in recent years. Decree No. 98/2021/ND-CP, in force since January 1, 2022, is the main reference for the management of Medical Devices and covers every aspect, from classification to importation, from registration to distribution.
To ease the transition, on January 1, 2025, the Vietnamese Government issued Decree No. 04/2025/ND-CP, amending and temporarily extending Article 76 of Decree No. 98/2021/ND-CP.
Decree No. 04/2025/ND-CP: Extension until June 30, 2025
Decree No. 04/2025/ND-CP temporarily extended the validity of certain import licences and provided for transitional arrangements until the key date of June 30, 2025.
It is essential to emphasise that these licences are genuine Market Authorisations (MA Licences), which are indispensable for selling and distributing Medical Devices in Vietnam.
Import licences must be applied for by an importer registered with the Ministry of Health or by a local authorised representative of the foreign manufacturer (MAH – Market Authorisation Holder).
Each licence is issued for a device identified by code or description and for a single manufacturer, as defined in the submitted documents.
The key points of Decree No. 04/2025/ND-CP:
- Extension of import licences for Medical Devices
Licences issued between January 1, 2018 and December 31, 2021, remain valid until June 30, 2025, without quantitative limitations. - Import of class C and D devices
Class C and D devices, classified and listed on the official portal of the Ministry of Health, can be imported without a licence until June 30, 2025. - Validity of registration numbers for biological IVDs
Registration numbers issued between January 1, 2014 and December 31, 2019, for in vitro diagnostic biological products remain valid until June 30, 2025.
Manufacturers who have obtained import licences may continue to use these licences to import Medical Devices until June 30, 2025.
In short, the Vietnamese government has given extra time to companies to adapt to the new rules, maintaining a simplified system to favour market continuity, but this extension has a clear deadline: June 30, 2025.
From July 1, 2025: Goodbye to Derogations and Full Implementation of Decree 98/2021/ND-CP
From July 2025, the transitional measures will no longer be in force. Manufacturers will therefore have to fully comply with the requirements of Decree 98/2021/ND-CP (and its amendments) for the import and marketing of Medical Devices in Vietnam.
- Extended licences expire, and a new application must be submitted according to the ordinary procedure.
- The import of class C and D devices requires a registration number issued by the Ministry of Health.
- IVD registration numbers issued in previous years lose their validity, and manufacturers must adapt to the new regulatory requirements.
Decree 98/2021/ND-CP in full force for Medical Devices in Vietnam
Decree 98/2021/ND-CP, fully implemented from July 1, 2025, sets out key requirements for all Medical Devices, including:
- Risk Classification (Classes A-D)
- Requirement of ISO 13485:2016 or CFS certification for imported devices
- Appointment of a local representative (MAH)
- Use of the CSDT format (from 2024 for Classes C and D)
- Labelling in Vietnamese
Vietnam is progressively aligning with international standards to ensure safety, traceability and quality of Medical Devices. While a flexible, systematic approach has prevailed until now, as of July 1, 2025, the rules are fully operational. Manufacturers must be ready; otherwise, import and marketing activities on the Vietnamese market will be suspended.
>>> Thema offers manufacturers strategic regulatory consultancy in the commercialisation of Medical Devices and in vitro diagnostics in Vietnam.
SOURCE:
Decree No. 98/2021/ND-CP
Decree 98/2021/ND-CP
06/16/2025
