The Vietnam Ministry of Health (MoH) released a draft Circular on 16 October 2025 outlining specific tasks and administrative procedures related to medical device management. The Circular also introduces detailed templates for documents and reports required to comply with the Ministry’s regulations.
Scope
Summary of the draft Circular issued by the Vietnam Ministry of Health (MoH) concerning delegation of medical device management tasks and related administrative procedures.
Key Highlights
Delegation of Responsibilities
Under this draft Circular, the MoH delegates the following responsibilities to the Infrastructure and Medical Device Administration (IMDA):
- Conduct post-inspections of circulation numbers for Class C and D medical devices.
- Revoke circulation numbers for Class C and D medical devices.
- Suspend or lift suspensions of circulation for specific batches, and recall batches posing potential health risks.
- Revoke Free Sale Certificates (FSCs) for Class C and D medical devices.
- Revoke certificates of registration for medical device inspection activities.
- Decide on re-inspection actions, including determining sample quantities or suspending use of noncompliant devices.
- Determine whether to continue re-inspection, increase sample quantities, or instruct registration number holders to recall all devices in a batch.
- Evaluate priority cases for processing medical device registration dossiers.
Administrative Tasks Assigned to IMDA
In addition, certain administrative tasks will be assigned to the IMDA, including:
- Granting new circulation numbers for Class C and D medical devices.
- Determining approval or denial for the circulation of Class C and D medical devices.
- Granting import licenses for medical devices.
- Issuing new Free Sale Certificates for Class C and D medical devices.
- Granting new and amended inspection registration certificates for medical devices.
Document Templates and Reporting Forms
The Circular also introduces updates and additions to document templates and reporting forms used in medical device management, including:
- Forms for announcement, disclosure, declaration, notification, and requests for new circulation numbers, import licenses, and Free Sale Certificates.
- Employee declaration form.
- Information forms on declaration dossiers, certificates, and import licenses.
- Classification result form.
- Authorization letter form.
- Certificate of warranty eligibility form.
- Technical brief form.
- Reports on export, import, inventory, use of medical devices, production materials, and substances containing narcotics/precursors.
- Commitment and request forms for continued circulation of medical devices.
Validity of Existing Documents
All documents submitted prior to the implementation of this Circular will remain valid, unless revisions or additions are deemed necessary.
Applicability
This Circular applies to agencies, organizations, and individuals engaged in activities related to medical devices, including classification, production, circulation, sale, import/export, service provision, information and advertising, as well as management and use at medical facilities.
Implications to Clients
Clients are advised to take note of the delegated administrative responsibilities carried out by the IMDA, including but not limited to:
- Granting new circulation licenses and Free Sale Certificates for Class C and D medical devices.
- Issuing import licenses for medical devices.
Free Sale Certificates for Class A and B medical devices will continue to be issued by the provincial Department of Health.
Certain documents in registration dossiers may be subject to revisions or updates. Andaman Medical will continue to work closely with clients to ensure all required updates are implemented in a timely manner.
Effective Date
The anticipated issuance and implementation of the Circular is scheduled to occur before 31 December 2025.
Attachment
See attached the draft Circular (Vietnamese version)
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