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The registration process for Class B medical devices with the Vietnam Ministry of Health (MOH) is governed by Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT. Class B devices are considered low-moderate risk and require a product listing (notification) before they can be imported or sold in Vietnam.
✅ Overview of the Class B Registration Process (Vietnam MOH)
Here are the main steps to register a Class B medical device in Vietnam:
🟢 Step 1: Determine the Device Classification
Use ASEAN Medical Device Classification Rules (based on GHTF) to confirm Class B.
Although not mandatory, you may obtain a classification confirmation letter from a licensed Vietnamese classification agency.
🟢 Step 2: Appoint an Authorized Representative (AR) in Vietnam
A foreign manufacturer must appoint a local company as the AR.
The AR must:
Be licensed to import and distribute medical devices
Have qualified technical personnel
Hold the legal responsibility for the product in Vietnam
🟢 Step 3: Prepare the Dossier for Registration
Key documents include:
| Document | Notes |
|---|---|
| Letter of Authorization (LOA) | Notarized, legalized, and translated into Vietnamese |
| Certificate of Free Sale (CFS) or equivalent | From the country of origin |
| ISO 13485 certificate | From the manufacturer |
| Technical File | According to ASEAN CSDT format |
| Label and IFU | Must be in Vietnamese |
| Risk management & test reports | ISO 14971, ISO 10993, IEC 60601 if applicable |
🟢 Step 4: Submit Online Application
Go to the MOH’s DMEC Portal: https://dmec.moh.gov.vn
The AR will:
Create an account
Upload all documents
Submit under "Class B - Product Notification"
🟢 Step 5: MOH Review
MOH reviews the submission for:
Completeness and accuracy
Compliance with standards and labeling
No technical evaluation or clinical data review is required for Class B
MOH may request corrections or clarifications
🟢 Step 6: Receive Listing Number
If approved, MOH will issue a Product Listing Number ("Số lưu hành").
This number is required for customs clearance, sales, and distribution.
📅 Processing Time & Cost
| Item | Details |
|---|---|
| Processing Time | ~10–15 working days (if no corrections needed) |
| Government Fee | ~500,000 VND (~20 USD) |
| Consultant Fee | Varies depending on AR and service provider |
🛑 Important Notes
No device may be imported or sold before the listing number is issued.
Any changes in the device, manufacturer, or AR after registration may require update or re-registration.
Maintain post-market surveillance and adverse event reporting through the AR.
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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