Vietnam Releases New Draft Circular Updating Medical Device Administrative Procedures

Vietnam’s Ministry of Health (MOH) issued a new draft Circular in November 2025, proposing significant updates to administrative procedures for medical device regulation. This move reflects Vietnam’s ongoing efforts to enhance regulatory efficiency, improve transparency, and ensure alignment with global standards as the country's healthcare market continues to expand rapidly.

This draft Circular consolidates and updates procedures across multiple regulatory areas, signalling an important step toward a more streamlined and responsive medical device framework.

Why This Draft Circular Matters

Vietnam is one of the fastest-growing medical device markets in Southeast Asia, and regulatory changes often have direct implications on:

• Market entry timelines

• Compliance obligations

• Operational readiness for manufacturers and distributors

• Provincial-level regulatory oversight

  
  

The latest draft aims to address industry feedback, modernise the administrative process, and enable better coordination between central and regional authorities.

Key Updates Proposed in the Draft Circular

The draft introduces revised procedures for several core regulatory functions:

1. Registration and Circulation Numbers

The draft clarifies documentation requirements and application formats for obtaining or renewing medical device circulation numbers. The changes aim to improve consistency and reduce administrative gaps experienced in past submissions.

2. Import Licensing

Vietnam continues to refine its import licensing pathway to support smoother access to essential medical devices. The updated process is expected to streamline approvals, particularly for devices without circulation numbers or for urgent public health needs.

3. Export and Free-Sale Certificates

The draft sets clearer guidelines for issuing export-related documents, helping manufacturers secure international market access with more predictable timelines.

4. Post-Market Reporting and Vigilance

Enhanced reporting requirements reflect Vietnam’s increasing focus on post-market safety. The draft emphasises:

• Incident reporting

• Periodic safety updates

• Obligations for both local registrants and foreign manufacturers

5. Decentralisation to Provincial Authorities

One of the most notable developments is the further delegation of regulatory tasks from the MOH to provincial Departments of Health (DOH).

This shift is expected to:

• Reduce processing delays

• Improve responsiveness

• Allow more localised oversight

It aligns with Vietnam’s broader digitalisation and administrative reform plans.

Implications for Industry Stakeholders

For Manufacturers and ARs

• Expect more structured application formats and document requirements

• Prepare for improved clarity but stricter compliance expectations

• Review product portfolios to ensure alignment with updated registration pathways

  
  

For Importers and Distributors

• Import licensing timelines may improve, but documentation standards will remain rigorous

• Strong coordination with local partners will be essential

  
  

For Hospitals and Healthcare Institutions

• Clearer guidance may simplify procurement processes

• Enhanced vigilance requirements will help improve device safety monitoring

  
  

What’s Next?

The MOH is currently receiving feedback on the draft Circular. Once finalised, it will replace or update several existing regulatory provisions related to administrative procedures in Vietnam’s medical device sector.

ARQon will continue to monitor regulatory developments in Vietnam and provide timely updates to help industry players stay compliant and strategically prepared.