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The process and procedure for registering Class B medical devices with the Vietnam Ministry of Health (MOH) follows the regulatory framework outlined in Decree 98/2021/ND-CP and its amendments (notably Decree 07/2023/ND-CP). Here's a comprehensive breakdown of the registration procedure:
🇻🇳 Process and Procedure for Class B Medical Device Registration with Vietnam MOH
🧾 1. Determine Device Classification
Use MOH’s risk-based classification rules to confirm your product is Class B.
You may optionally obtain a classification result from a licensed Vietnamese classification organization.
👤 2. Appoint a Local Authorized Representative (AR)
Foreign manufacturers must appoint a Vietnamese-based entity (AR) to handle the registration and post-market responsibilities.
The AR must be:
A legally registered company in Vietnam
Possess appropriate business scope for importing and/or distributing medical devices
📂 3. Prepare Registration Dossier
The application must include the following documents:
| No. | Document | Notes |
|---|---|---|
| 1 | Application form (Form 01, Annex I) | Signed by the AR |
| 2 | Business license of AR | Certified copy |
| 3 | Authorization letter from the manufacturer | Legalized and notarized |
| 4 | Free Sale Certificate (FSC) | Issued by the competent authority in the country of origin (notarized and legalized) |
| 5 | ISO 13485 certificate | Of the manufacturer |
| 6 | Product Technical Dossier | Includes device description, specs, intended use, packaging, labeling, instructions for use, risk analysis, etc. |
| 7 | Vietnamese Label and Instructions for Use (IFU) | Must comply with MOH labeling regulations |
| 8 | Device classification result | From an authorized organization (optional but recommended) |
🌐 4. Submit Application on MOH Portal
Go to the Vietnam MOH’s Medical Device Management Portal:
👉 https://dmec.moh.gov.vnSteps:
Create an account (if not already registered)
Log in as the AR
Fill in device details and upload the full dossier
Submit for review
🕒 5. MOH Review and Approval
For Class B devices, the registration is notification-based, not subject to technical review.
If the application is complete and valid, a Listing Number (Số lưu hành) is issued.
Processing time: 5–10 working days (may vary depending on MOH workload)
🧾 6. Receive Listing Number
Once approved, the device is granted a permanent Listing Number.
This number allows for legal marketing, importation, and distribution of the device in Vietnam.
The listing is valid indefinitely, unless revoked due to non-compliance or product changes.
📦 7. Post-Market Responsibilities
The AR must:
Ensure labeling compliance and accurate Vietnamese translations
Monitor and report adverse events or device malfunctions
Notify MOH of any changes to the product or registration details
Maintain proper distribution and service records
✅ Summary of the Key Steps:
| Step | Description |
|---|---|
| 1 | Classify the device as Class B |
| 2 | Appoint an Authorized Representative |
| 3 | Prepare and compile required documents |
| 4 | Submit application via the MOH online portal |
| 5 | Wait for MOH listing number issuance |
| 6 | Begin marketing the device in Vietnam |
Would you like:
A full document checklist template?
Help preparing or reviewing your dossier?
Sample forms or Vietnamese translation assistance?
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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