On 24 March 2026, the Vietnam Ministry of Health (MoH) issued Official Letter No. 1956/BYT-HTTB, requesting organizations involved in the production, registration, importation, and trading of medical devices to submit a report reviewing the implementation of Decree No. 98/2021/NĐ-CP on medical device management.
This request supports the development of a revised decree in line with Decision No. 485/QĐ-BYT (dated 13 February 2026), which sets out the Ministry’s 2026 legal work plan, including amendments or replacement of the current regulatory framework.
Read the full notice here [PDF]
Scope of Application
This Notice applies to organizations involved in the:
- Production of medical devices
- Registration of medical devices
- Importation of medical devices
- Trading of medical devices
Regulatory Background
Organizations are asked to assess the implementation of Decree No. 98/2021/NĐ-CP and its subsequent amendments under related decrees, including:
- Decree No. 07/2023/NĐ-CP
- Decree No. 96/2023/NĐ-CP
- Decree No. 85/2024/NĐ-CP
- Decree No. 04/2025/NĐ-CP
- Decree No. 342/2025/NĐ-CP
Required Report Structure
As outlined in Official Letter No. 1956/BYT-HTTB, the report should include the following sections:
1. General Information
- Overview of the organization and its activities related to medical devices
2. Implementation Results
- Assessment of the implementation of legal documents related to Decree 98 and its amendments
- Evaluation of achievements, strengths, challenges, and limitations
- Analysis of the causes of identified issues
- Description of practical difficulties encountered
- Any other relevant information
3. Proposals and Recommendations
- Suggestions to enhance the effectiveness of medical device management
- Recommendations for amending or supplementing existing regulations to address gaps, inconsistencies, or practical challenges
- Identification of provisions that should be revised, added, or removed to better align with real-world implementation
Submission Requirements
Reports must be submitted to the MoH (Vietnam Infrastructure and Medical Devices Administration – VIMDA) by 15 April 2026 for consolidation.
An electronic copy should also be sent via email to vimda@moh.gov.vn to support the drafting of the revised decree.
Implications to Clients
Clients should closely monitor the development of the new decree amending Decree No. 98/2021/NĐ-CP.
It is advisable to review internal activities and provide feedback to VIMDA to ensure that practical considerations are reflected in the upcoming regulatory framework.
Effective Date
The notification takes effect on March 24, 2026.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com.