Vietnam Medical Device Registration: Step-by-Step Regulatory Guide
Registering medical devices with the Vietnam Ministry of Health (MOH) requires strict adherence to local laws. Under the latest Consolidated Document No. 08/VBHN-BYT (which merges Decree 98/2021 and its amendments), all successful registrations are now valid indefinitely.
This comprehensive guide covers device classifications, new online portal changes, required documents, and critical timelines for international manufacturers.
📊 Vietnam Medical Device Classification & Timeline Overview
Medical devices in Vietnam are classified into four categories (Class A, B, C, and D) based on risk level.
Note: The MOH has implemented a 50% fee reduction for registrations through December 31, 2026. Submit your files early to take advantage of these savings.
| Device Class | Risk Level | Target Review Time | Actual Review Time | Application Type |
|---|---|---|---|---|
| Class A | Low Risk | Immediate | 3 to 5 Days | Declaration of Applied Standards |
| Class B | Low-Medium Risk | Immediate | 30 to 60 Days | Marketing Authorization Certificate |
| Class C | Medium-High Risk | 10–90 Days | 6 to 12+ Months | Marketing Authorization Certificate |
| Class D | High Risk | 10–90 Days | 6 to 12+ Months | Marketing Authorization Certificate |
🛠️ Step-by-Step Pathway to Vietnam MOH Approval
Step 1: Appoint a Local Authorized Representative (AR)
Foreign manufacturers cannot submit applications directly to the government. You must legally appoint a local Registration Holder based in Vietnam. This local business entity will manage your submissions and act as your legal liaison with the MOH.
Step 2: Product Classification and Self-Testing
Under the updated Decree 98 framework, the local Registration Holder can perform product classification as part of the application process. You must ensure your product lines align with Circular No. 57/2025/TT-BYT, which implements strict technical and quality standards ahead of the 2027 procurement reforms.
Step 3: Prepare the CSDT Technical Dossier
All applications for Class B, C, and D devices must follow the ASEAN Common Submission Dossier Template (CSDT) format. All core files must be accurately structured and translated into Vietnamese by certified translators to pass the initial administrative screening.
Step 4: Digital Portal Submission
All filings must be processed through the online system.
- Important 2026 Tech Update: The MOH has migrated its online public service portal. All new filings should be submitted via the new domain at VIMDA MOH Portal. The legacy IMDA portal domain will permanently shut down on September 30, 2026.
📋 Required Documents for MOH Vietnam Submission
To ensure a successful evaluation by the Department of Infrastructure and Medical Devices, organize the following legal and technical papers:
- ISO 13485 Certificate: Mandatory quality management standard for the device’s manufacturing facility.
- Free Sale Certificate (CFS): Proof of lawful commercialization in your home country.
- Letter of Authorization (LOA): Officially legalized document naming your local representative in Vietnam.
- Technical Product Dossier (CSDT): Full technical description, specifications, and clinical evaluation data.
- Compliant Labels & IFU: Instructions for Use and packaging must comply with the strict import criteria defined under the new Decree 37/2026/ND-CP on Goods Labeling.
❓ Frequently Asked Questions (FAQ)
Do medical device registrations expire in Vietnam?
No. Under the current Decree 98 system, newly issued circulation numbers (Số lưu hành) are valid indefinitely. You do not need to process fixed 5-year renewals anymore. However, older devices registered under legacy decrees must still be systematically converted to comply with the modern framework.
Does Vietnam accept CE Marks or US FDA approvals?
Yes. Vietnam accepts reference country approvals, including CE Marks and US FDA clearings. Presenting these tier-one global certificates allows your local agent to utilize fast-track verification pathways, lowering target processing delays down to 10 business days for complex Class C and D items.
Can we change our local distributor after device registration?
Yes, but the process is highly dependent on your contract. Because your local representative legally owns the registration number, it is crucial to use an independent Authorized Representative (AR) rather than a commercial distributor. This prevents your intellectual property from being held hostage if you change distributors.
What are the advertising rules for medical devices in Vietnam?
Medical device advertising is now governed by Decree 342/2025/NĐ-CP. Device promotion has been moved under Vietnam’s broad Law on Advertising framework. While separate product advertising permits are no longer required, the MOH has significantly increased post-market compliance scrutiny on online content and digital marketing.
