Fast-Track vs. Standard Registration Pathway of Medical Device Registration in Vietnam

Medical device registration in Vietnam has become increasingly important as the country emerges as one of the most dynamic markets in Southeast Asia. Its regulatory framework has been strengthened in recent years, particularly with the implementation of Decree 98/2021/ND-CP and subsequent updates, aligning more closely with global best practices.

This overview highlights the differences between the fast-track and standard registration pathways, outlining unique aspects, timelines, processes, and practical considerations for companies planning market entry.

Vietnam’s Acceptance of Reference Approvals

Vietnam stands out in Southeast Asia due to its broad acceptance of reference approvals. The Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) recognize approvals from major regulatory authorities:

• Primary reference agencies: USFDA, Health Canada, EU (CE mark), Japan (PMDA), Australia (TGA).
• Secondary reference agencies: Switzerland, China (NMPA), Korea (MFDS).

Compared to neighboring markets such as Thailand, Indonesia, or Malaysia, Vietnam’s inclusion of China (NMPA) and Korea (MFDS) as acceptable references is relatively rare. Most other Southeast Asian countries prioritize only the “big five” reference agencies. This wider recognition creates more flexible fast-track opportunities for manufacturers and potentially shortens time to market.

Vietnam Medical Device Registration Timelines

• Class A & B - Around 1 week for approval.
• Class C & D with reference approvals (fast-track) – Shortened timelines (often several months faster than standard), but CSDT dossiers are still required.
• Class C & D without reference approvals (standard pathway) – Typically 9 - 12 months or longer, depending on dossier completeness and review capacity.

Vietnam Medical Device Registration Pathway

Vietnam has adopted the ASEAN Common Submission Dossier Template (CSDT) as the backbone of its regulatory review for Class C and D devices.

Standard Medical Device Registration Pathway (No Reference Approvals):

• Full CSDT appraisal is conducted by the MOH’s designated authorities below: NIMEC (National Institute of Medical Device and Construction): General Medical Device Class C – D.
• NICVB (National Institute for Control of Vaccine Biologicals): IVD Class C - D.
• This includes a comprehensive technical review, risk/benefit evaluation, labeling checks, and in some cases, requests for clarification.

Fast-Track Medical Device Registration Pathway (with reference approvals):

• CSDT dossier is still required, but the level of scrutiny is reduced. There is no CSDT appraisal requirement prior registration.
• The MOH often relies on prior approval evidence from recognized agencies.
• While appraisal is less detailed than the standard pathway, the submission must still meet format and content requirements of CSDT.

Fast-track does not exempt companies from submitting CSDT, but the depth of review is lighter, without CSDT appraisal requirement from MOH authorities, leveraging reliance on reference approvals.

Role of National Institutes in Testing and Quality Certification

For certain high-risk IVDs and biologics, Vietnam requires quality evaluation through national institutes:

• NICVB (National Institute for Control of Vaccine and Biologicals): designated as the competent authority responsible for the assessment and verification of the quality of in vitro diagnostic (IVD) medical devices in Vietnam.
• In special cases, the Ministry of Health may designate another qualified inspection agency.

When is Local Testing Required for Medical Devices in Vietnam?

• IVDs with reference approvals: Local testing and quality certification are waived.
• IVDs without reference approvals: High-risk categories (Class C, Class D, e.g., HIV, HBV, oncology diagnostics) require local testing and a Certificate of Quality before registration.
• Lower-risk IVDs (Class A - B): Not require local testing if sufficient validation data is provided.

Timelines and Costs Medical Device Registration in Vi

• Local testing and certification may add 3 - 6 months to the registration process.
• Costs vary depending on test complexity, typically ranging from USD 2,000 - 10,000 per product.

Practical Examples

To illustrate the impact of reference approvals on registration timelines:

• Case 1: Class C - D IVD without reference approvals
  • Requires full CSDT appraisal, local testing, and Certificate of Quality.
  • Timeline: 12 - 18 months (including testing).
• Case 2: Class C - D IVD with reference approvals
  • Eligible for fast-track, reduced dossier review, and exemption from local testing.
  • Timeline: 6 - 9 months.

This demonstrates that reference approvals can cut the timeline by half, representing a major advantage for manufacturers with existing approvals in the EU, US, or other recognized jurisdictions.

Final Thoughts

Vietnam’s medical device registration system is evolving into one of the most structured and internationally aligned in Southeast Asia. Its broad acceptance of reference approvals, coupled with clear fast-track pathways, makes it attractive for global manufacturers. However, companies must plan carefully for dossier preparation, anticipate local testing requirements for high-risk IVDs, and allocate sufficient time and resources for regulatory interactions.

By leveraging reference approvals and understanding the nuances of CSDT appraisal and national institute roles, companies can significantly optimize their time-to-market in Vietnam.

Further Information

If you are a medical device manufacturer with questions about timelines, costs, or dossier requirements for the Vietnam market, please contact Cisema.

Discover more about our medical device registration service in Vietnam.

About the Author: Shouzheng Tan

Shouzheng Tan is Vice President of Southeast Asia at Cisema, based in Penang, Malaysia. He brings more than a decade of experience in the medical device industry, specializing in regulatory registration and market access across Southeast Asia. In his role, he works closely with overseas manufacturers to develop and implement effective regulatory strategies for medical devices throughout the region, including key markets such as Malaysia. His expertise is complemented by working knowledge of quality management systems, allowing him to support clients across both regulatory and compliance requirements.