Vietnam Expands CSDT Appraisal Capacity for Medical Devices

On September 30, 2026, Vietnam’s Ministry of Health (MOH) issued Decision No. 3046/QĐ-BYT, designating additional bodies to appraise medical device dossiers under the ASEAN Common Submission Dossier Template (CSDT).

For medical device manufacturers, Vietnam’s expanded CSDT appraisal network could:

• Improve access to technical appraisal services, giving manufacturers more options for dossier review
• Help distribute review workloads as demand for medical device registration grows
• Expand appraisal options for devices without approval from a recognized reference country, which may require more extensive technical review

However, expanding the appraisal network does not reduce the underlying regulatory requirements or guarantee shorter registration timelines.

When Is CSDT Appraisal Required in Vietnam?

A CSDT appraisal result is an official assessment of a medical device’s technical dossier by an MOH-designated body. It evaluates whether the submitted documentation adequately supports the device’s safety, quality, and performance.

For applicable marketing authorization applications submitted on or after January 1, 2024, the requirement for CSDT appraisal depends on:

• The device’s risk classification and applicable regulatory requirements.
• Whether the device has approval from a recognized reference country.
• The requirements applicable to the intended marketing authorization route.

Devices subject to this requirement generally follow the regular registration pathway, which places greater emphasis on technical dossier review. Manufacturers should establish whether CSDT appraisal is required early in the registration process to plan documentation, costs, and timelines accordingly.

Key Considerations for Medical Device Manufacturers

The additional designations give manufacturers more options for CSDT appraisal, but whether they translate into faster reviews remains to be seen. Much will depend on when the new bodies begin accepting applications, their capacity, and their review timelines. Before choosing a provider, manufacturers should confirm its availability, expected turnaround time, and fees, which have not yet been announced for the newly designated bodies.

More appraisal options do not mean fewer regulatory hurdles. Manufacturers must still meet the eligibility criteria for their registration pathway and submit a compliant CSDT dossier.

Final Thoughts

For manufacturers preparing to enter or expand in the Vietnamese market, the priority remains clear: determine the applicable registration pathway, establish whether CSDT appraisal is required, and ensure the dossier is ready for review. Choosing the right appraisal provider and preparing a robust submission from the outset can help reduce avoidable delays and keep registration plans on track.

To navigate these requirements with greater confidence, manufacturers can benefit from expert support at each stage of the process. Cisema can help determine whether CSDT appraisal is required, assess dossier readiness, and coordinate medical device registration in Vietnam. To discuss youe registration strategy and identify the next steps for your medical device in Vietnam, contact Cisema today.

Further Information

• Explore Cisema’s Vietnam medical device registration services.
• Read about the differences between standard and fast-track medical device registration in Vietnam.

References

• Decision No. 3046/QĐ-BYT