Overview of the New Circular
On 22 November 2025, the Vietnam Ministry of Health (MoH) issued a new Circular detailing updated administrative procedures and regulatory requirements for medical device management. The Circular provides:
- Specific assignments of authority to the Infrastructure and Medical Device Administration (IMDA)
- Updated requirements for documentation and reporting
- New and revised templates to standardize regulatory submissions
This Circular strengthens oversight across the medical device lifecycle and clarifies regulatory responsibilities for higher-risk device categories.
To read the full announcement: Circular 44 regulating the decentralization of implementation in the field of medical equipment, and regulations on form document and report.pdf
IMDA Responsibilities Under the Circular
The Circular delegates expanded regulatory and enforcement responsibilities to the IMDA, particularly concerning Class C and D medical devices. These responsibilities include:
Licensing and Approvals
- Granting new circulation numbers for Class C and D medical devices
- Issuing import licenses for medical devices
- Issuing, re-issuing, and revoking Free Sale Certificates (FSCs)
- Issuing, supplementing, and revoking certificates of registration for medical device inspection activities
Regulatory Oversight & Inspections
- Conducting post-inspections of circulation numbers for Class C and D devices
- Inspecting organizations and individuals involved in:
- Classification
- Production, circulation, sale, export, import
- Service provision
- Information and advertising
- Management and use of medical devices at healthcare facilities
Corrective & Enforcement Actions
- Suspending or lifting suspensions of circulation for specific batches
- Recalling defective batches that pose health risks
- Revoking circulation numbers for Class C and D devices
- Issuing documents permitting the continued circulation of medical devices
- Deciding actions for devices that fail inspection requirements
Updated Document Templates and Reporting Forms
The Circular introduces new and revised templates to be used for regulatory submissions and compliance reporting. These include:
- Annex I: Forms for announcements, disclosures, declarations, notifications, and requests (circulation numbers, import licenses, FSCs)
- Annex II: Employee declaration form
- Annex III: Information forms for dossiers, certificates, and import licenses
- Annex IV: Forms for commitments and requests related to continued circulation
- Annex V: Authorization letter form
- Annex VI: Certificate of warranty eligibility form
- Annex VII: Technical brief form
- Annex VIII: Reporting templates covering export, import, inventory, device usage, production materials, and narcotics/precursor substances
Validity of Previously Submitted Documents
- All documents submitted prior to the implementation of this Circular remain valid unless updates are required.
- Authorization letters and Certificates of Warranty Eligibility signed before implementation also remain valid and may continue to be used.
Implications to Clients
Manufacturers, importers, and authorized representatives should take note of the following:
- IMDA will now handle:
- New circulation numbers for Class C and D devices
- Free Sale Certificates
- Import licenses
- Circulation licenses for Class A and B devices will continue to be issued by provincial Departments of Health.
- Registration dossiers may require updates or revised documents to comply with the new templates and procedures.
- Andaman Medical will continue to support clients to ensure timely updates and compliance with the new Circular.
Effective Date
The Circular is effective from 22 November 2025.
For inquiries or support regarding the implementation of the new Circular and medical device regulatory requirements in Vietnam, please contact sales@andamanmed.com or reach out to us for guidance.
