On December 11, 2025, the Vietnam Ministry of Health (MoH) issued Decision No. 3830, establishing internal and electronic procedures for handling administrative procedures related to medical devices under the MoH’s authority.
Read the full announcement: PDF link
Clients are advised to review the original Vietnamese version for complete procedural details, including official forms and implementation guidance. An official English translation has not been issued by the Ministry of Health.
Scope
Establishment of standardized internal and electronic administrative procedures for medical device–related regulatory activities administered by the Vietnam Ministry of Health.
Key Points
Decision No. 3830 promulgates ten (10) internal and electronic procedures, including procedures for:
- Granting new circulation numbers for Class C and D medical devices that comply with applicable national standards
- Granting new circulation numbers for Class C and D medical devices that are measuring instruments subject to sample approval in accordance with measurement laws
- Granting new circulation numbers for Class C and D medical devices under the fast-track route
- Granting new circulation numbers for Class C and D medical devices used for epidemic prevention and control, and for addressing the consequences of natural disasters and emergencies
- Granting new circulation numbers for other Class C and D medical devices
- Continued circulation of Class C and D medical devices in cases where the product owner ceases production, becomes bankrupt, or is dissolved
- Granting Free Sale Certificates (FSCs) for Class C and D medical devices
- Granting import licenses for medical devices
- Granting certificates of registration for medical device inspection activities
- Supplementing and amending certificates of registration for medical device inspection activities
For each procedure, the Decision clearly specifies the purpose, scope, and procedural content, including dossier requirements, implementation steps, departmental responsibilities, processing timelines, applicable fees, and standardized forms.
Notable Updates
Compared with the previous procedural framework, Decision No. 3830 introduces several important changes, including:
- Defined processing timelines:
- 10 working days for fast-track applications
- 45 working days for normal applications
(calculated from the date of receipt of complete dossiers and applicable fees)
- Standardized administrative forms, including:
- Application receipt and result appointment form
- Application refusal form
- Apology and revised result delivery appointment form
These updates aim to improve consistency, predictability, and transparency in regulatory administration.
Implications to Clients
- Greater regulatory certainty
Clearly defined review timelines allow manufacturers to better plan registration, market entry, and supply strategies. - Enhanced transparency and accountability
Standardized forms and clearer procedural steps improve visibility into application status and provide clearer explanations in cases of refusal or delay. - Improved administrative efficiency
The formalization of internal and electronic procedures is expected to streamline dossier assessment and reduce administrative bottlenecks. - Clearer compliance expectations
Detailed dossier requirements and defined departmental responsibilities help reduce deficiencies and resubmissions. - Facilitated access in urgent and special cases
Dedicated fast-track and emergency-use procedures support timely approvals for epidemic control and disaster response scenarios.
Effective Date
December 11, 2025
If you require clarification or support regarding medical device regulatory requirements in Vietnam, our regulatory team is available to assist.
For inquiries, please contact sales@andamanmed.com.
