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May 16, 2025
Approximately 5 minutes
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
Vietnam IVD Device Registration: Decree 98 and the Transition to Medical Device Status
In Vietnam, the regulation of In Vitro Diagnostic (IVD) devices is undergoing a significant transition under Decree No. 98/2021/ND-CP. Previously, standalone reagents were regulated as pharmaceuticals; however, the new framework unifies all IVD products under the medical device regulations, overseen by the Ministry of Health (MoH).
Classification and Grouping
Vietnam follows the GHTF guidelines for risk-based classification (Class A to D).
- Risk Classification: IVD components are classified based on the intended end-use risk of the entire system. For example, IVD components used together as a system can be classified according to the highest risk level of the combined system.
- Grouping: Vietnamese regulations feature unique product grouping rules. Manufacturers often need more applications than in other markets to cover all models, particularly due to complexity in grouping by number of models, portability, and risk class.
Regulatory Pathway: Market Authorization (MA) License
All classes of IVD devices are now required to obtain a Market Authorization (MA) License.
- Validity: MA Licenses do not expire under the new Decree, providing indefinite market access once granted.
- Local Agent: A foreign manufacturer must appoint a local, registered company in Vietnam to act as the Registration Holder to submit the application and maintain the license.
| Class | Review Time (Target) | Pathway |
|---|---|---|
| Class A/B | Immediate (Approx. 5 days) | Quick administrative review and Notification process by the provincial Health Department. |
| Class C/D | Target: 10–90 days (Actual: Highly delayed) | Full Technical Review by the central MoH. |
Expedited Review for Class C and D
The MoH encourages manufacturers of Class C and D IVDs to utilize the Reference Country Approval pathway to expedite the review process:
- Reference Countries: Approval from the USA, Canada, EU, Japan, Australia, China, or Korea can be used to waive the Technical Review requirement.
- Timeline Benefit: This is intended to shorten the review time from up to 90 days (Technical Review) to approximately 10 working days.
Documentation and Compliance
- Documentation Format: Applications are transitioning from requiring standard administrative documents and a technical summary to the Common Submission Dossier Template (CSDT) format.
- Language: Documentation may be submitted in Vietnamese or English during the transition period, but the Instructions for Use (IFU) and Technical Summary must be in Vietnamese.
- Quality System: An ISO 13485 certificate is required for Class B, C, and D devices to demonstrate Quality Systems Conformity.
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