ReOn 11 December 2025, the Vietnamese Ministry of Health (MOH) officially promulgated a key regulatory decision introducing 10 standardized and fully electronic internal administrative workflows governing the registration, circulation, and management of Class C and Class D medical devices.
This initiative aims to advance standardization, transparency, and efficiency in Vietnam’s medical device administrative approval system, marking a significant step in the country’s regulatory reform.
Legal Basis
The decision is issued based on multiple legal instruments, primarily including:
- Law on Medical Devices and its implementing decrees, such as Decree No. 98/2021/ND-CP and its subsequent amendments
- Government regulations on administrative procedure reform, including Decree No. 118/2025/ND-CP
- Ministry of Finance circulars on regulatory fees, such as Circular No. 64/2025/TT-BTC
Effective Date
The decision takes effect from the date of signing and promulgation.
Key Annexes
- Annex I: List of 10 administrative procedures
- Annex II: Detailed internal workflows corresponding to each of the 10 procedures
Interpretation of the Ten Core Workflows and Key Timelines
The accompanying tables provide a detailed overview of the objectives, scope of application, and clearly defined timelines for each of the ten workflows.
| Procedure Code | Procedure Name | Primary Objective | Prescribed Processing Timeline (Calculated from Receipt of a Complete and Valid Dossier) | Fee (VND) |
| QTNB.HTTB.01 | Procedure Name: Initial issuance of circulation licenses for Class C and D medical devices with established national standards | Standard registration pathway | 30 days | VND 3,000,000 |
| QTNB.HTTB.02 | Initial issuance of circulation licenses for Class C and D medical devices requiring metrological approval | Medical devices classified as measuring instruments | 30 days | VND 3,000,000 |
| QTNB.HTTB.03 | Initial issuance of circulation licenses for Class C and D medical devices eligible for expedited review | ccelerated approval (e.g. devices already approved by reference authorities such as the U.S., EU, Japan, or South Korea) | 10 days | VND 3,000,000 |
| QTNB.HTTB.04 | Emergency issuance of circulation licenses for Class C and D medical devices for epidemic prevention, disaster relief, or other emergency situations | Response to public health emergencies | 10 days | VND 3,000,000 |
| QTNB.HTTB.05 | Initial issuance of circulation licenses for Class C and D medical devices under other circumstances | Residual / fallback regulatory pathway | 45 days | VND 3,000,000 |
| QTNB.HTTB.06 | Authorization for continued circulation of medical devices after manufacturer discontinuation | Ensuring continuity of market supply | 15 working days | ot applicable |
| QTNB.HTTB.07 | Issuance of Certificate of Free Sale (CFS) | Primarily for product export purposes | 3 working days | VND 500,000 |
| QTNB.HTTB.08 | Issuance of medical device import permits (non-commercial purposes) | Scientific research, exhibitions, humanitarian aid, etc. | Emergency: 2 days Standard: 15 days | VND 1,000,000 |
| QTNB.HTTB.09 | Issuance of registration certificates for calibration/verification activities | Qualification and accreditation of calibration bodies | 10 working days | VND 1,500,000 |
| QTNB.HTTB.10 | Amendment and supplementation of issued registration certificates for calibration/verification activities | Updating institutional qualification information | 10 working days | VND 1,500,000 |
Important Notes on Timelines
Upon review of the official documents:
- Most workflows (e.g., QTNB.HTTB.01 to QTNB.HTTB.05) specify time limits in “ngày” (days), which in Vietnamese administrative practice generally refers to calendar days.
- Certain workflows (e.g., QTNB.HTTB.06, 07, 09, and 10) explicitly use “ngày làm việc” (working days).
In practice, stakeholders are advised to follow the final official interpretation issued by the competent authorities.
Key General Rules and Features
Legal Foundation
The workflows are grounded in Vietnam’s Law on Medical Devices and its latest implementing regulations, including Decree No. 98/2021/ND-CP, ensuring legal consistency and enforceability.
Digitalized and “One-Stop” Processing
All procedures must be submitted and processed through the Ministry of Health’s online portal, reinforcing a fully electronic and centralized regulatory system.
Standardized Procedures and Defined Timelines
Each workflow clearly specifies all internal steps—from application receipt and technical review to approval and certificate issuance—along with responsible units and defined timelines, significantly enhancing transparency and operational efficiency.
Key Documentation Requirements
- Common documents: Application forms, ISO 13485 certificates, letters of authorization, and related materials.
- Special requirements:
- Expedited review pathway (QTNB.HTTB.03): Applicants must provide marketing authorization approvals issued by designated “reference authorities,” such as the U.S. FDA, European Union, Japan PMDA, and other recognized regulators.
- Technical documentation:
- As of 1 January 2024, submissions must include an ASEAN Common Submission Dossier Template (CSDT) compliant technical summary.
Standardized Supporting Forms
The decision includes seven standardized forms (BM01 to BM07) covering all stages of the process, such as:
- Application receipt acknowledgments
- Requests for dossier supplementation
- Rejection notices
- Certificate templates
- Apology letters
- Process control cards
- Dossier tracking records
These forms further institutionalize consistency and traceability across the approval process.
Regulatory Significance
This decision represents a major milestone in the modernization of Vietnam’s medical device regulatory framework by:
- Refining procedures: Clearly categorizing complex registration scenarios into well-defined workflows
- Clarifying timelines: Establishing maximum processing timelines to improve predictability and planning for applicants
- Aligning with international practices: Recognizing approvals from selected reference countries to streamline market entry for high-quality products
- Enhancing transparency: Reducing discretionary decision-making through detailed internal procedural rules
Implications for Manufacturers and Importers
For medical device manufacturers and importers, this decision serves as the latest, authoritative, and operationally actionable guidance for understanding regulatory expectations and entering the Vietnamese market, particularly for Class C and D medical devices.