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April 16, 2025
Approximately 5 minutes
Vietnam Medical Device Registration: Decree 98, MA License, and Transitioning Market
Vietnam Medical Device Registration: Decree 98, MA License, and Transitioning Market
Medical device regulation in Vietnam is administered by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MoH). The current regulatory framework is defined by Decree No. 98/2021/ND-CP, which significantly restructured the market access pathway, moving from a complex Import License system to a Market Authorization (MA) License system.
Key Regulatory Framework and Local Representation
- Governing Law: The primary regulation is Decree No. 98/2021/ND-CP (effective January 1, 2022), which is currently undergoing transition periods and delays, extended by subsequent Decrees (e.g., Decree 07/2023).
- MA License: All medical devices require a Market Authorization (MA) License for importation and marketing. Once issued, MA Licenses do not expire.
- Local Representative: Foreign manufacturers must appoint a local, registered company in Vietnam to act as the Registration Holder (MA Holder) and submit applications. The Registration Holder can authorize an unlimited number of distributors to import under the MA License.
Classification and Regulatory Pathway
Vietnam follows the GHTF guidelines, classifying devices into four risk classes (A, B, C, D).
| Class | Risk Level | Review Time |
|---|---|---|
| Class A | Low | Immediate (Notification) |
| Class B | Medium-Low | Immediate (Notification) |
| Class C | Medium-High | Target: 10–90 days. Actual: 1+ years |
| Class D | High | Target: 10–90 days. Actual: 1+ years |
1. Class A and B Devices (Notification)
- Process: These low-risk devices undergo a quick administrative Notification process overseen by the provincial Health Department.
- Approval: Registration numbers are issued immediately upon submission, with approvals often granted within 1 week if Reference Country approval is leveraged.
2. Class C and D Devices (MA License)
- Review: These high-risk devices require a full MA License and are subject to central MoH review, which currently faces significant delays (Actual time often exceeds 1 year).
- Documentation: Applications may be submitted in Vietnamese or English until at least January 1, 2025. Eventually, the Common Submission Dossier Template (CSDT) format will become mandatory.
Expedited Review via Reference Country Approval
The MoH offers an expedited review pathway for Class C and D devices to mitigate the application backlog:
- Reference Countries: Approval from any of the following countries can waive the technical dossier evaluation: USA, Canada, Europe, Japan, Australia, China, and Korea.
- Timeline: This pathway is intended to shorten the review time from 60 working days to 10 working days, although significant backlogs persist.
Quality Systems and Labeling
- Quality System: An ISO 13485 certificate is required to demonstrate Quality Systems Conformity Assessment for Class B, C, and D devices.
- Labeling: Special labeling requirements include the registration number and License Holder contact information. The Instructions for Use (IFU) and Technical Summary must be in Vietnamese.
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