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What are the procedures, required documents, and precautions for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:25:34 The author: source:
Here’s a complete guide to the procedures, required documents, and precautions for registering a Class B medical device with the Vietnam Ministry of Health (MOH) under Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.

Here’s a complete guide to the procedures, required documents, and precautions for registering a Class B medical device with the Vietnam Ministry of Health (MOH) under Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.

✅ I. Procedures for Class B Medical Device Registration (Vietnam MOH)

1. Device Classification

  • Confirm the device is Class B (moderate risk).

  • You can optionally get a classification certificate from a licensed Vietnamese organization.

2. Appoint an Authorized Representative (AR)

  • A Vietnam-based legal entity must act as your AR.

  • AR will:

    • Create a user account on the MOH portal

    • Submit your dossier

    • Be legally responsible for post-market activities

3. Prepare Registration Dossier

  • Gather all required documents (see section II below).

  • Documents must be translated into Vietnamese if not originally in Vietnamese.

4. Online Submission via MOH Portal

  • MOH Portal: https://dmec.moh.gov.vn

  • The AR logs in and:

    • Uploads the dossier

    • Fills in device information

    • Submits the application

5. MOH Review & Issuance of Listing Number

  • Class B uses a notification process:

    • No technical review

    • If complete, the system automatically generates the Listing Number

  • Typical timeframe: 5–10 working days

6. Market the Product in Vietnam

  • Once you receive the Listing Number (Số lưu hành), you can begin importation and distribution.

📄 II. Required Documents for Class B Registration

No.DocumentFormat
1Application Form (Form 01, Annex I)Signed & stamped by AR
2Business License of ARCertified copy
3Letter of Authorization from manufacturerNotarized & legalized
4Free Sale Certificate (FSC)Legalized copy
5ISO 13485 CertificateFor the manufacturing site
6Product Technical FileIncludes device specs, function, risk info
7Labels & IFU in VietnameseMust comply with MOH labeling rules
8Classification Result (optional)Recommended from licensed entity in Vietnam

⚠️ III. Key Precautions

AspectPrecaution
🔍 AccuracyEnsure documents (FSC, ISO, LOA) are consistent and match device details.
🗂 Document FormatMust be in PDF format, clearly scanned, and properly labeled.
🌐 Portal AccountOnly a registered AR can submit the application. Foreign manufacturers cannot apply directly.
🕑 TimelinesDelays happen if documents are incomplete or translations are unclear.
📝 LabelingMust be in Vietnamese and comply with the latest MOH guidance (including model number, origin, AR info).
🔁 ChangesAny change in device, labeling, or AR must be updated with the MOH.
📋 Post-marketAR must track product complaints, report adverse events, and manage recalls.

🧾 Summary Checklist

✅ Appoint Authorized Representative
✅ Prepare all required documents
✅ Translate documents into Vietnamese
✅ Submit via dmec.moh.gov.vn
✅ Get Listing Number
✅ Start marketing and comply with post-market obligations

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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