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How to register and apply for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:37:10 The author: source:
To register and apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a simplified notification-based process (not full evaluation) governed by Decree 98/2021/ND-CP.

To register and apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a simplified notification-based process (not full evaluation) governed by Decree 98/2021/ND-CP. Here's a full guide to help you understand and carry out the process:

📝 Step-by-Step: How to Register a Class B Medical Device with the Vietnam MOH

✅ Step 1: Classify Your Device

  • Use ASEAN/GHTF classification rules to confirm the device falls under Class B (low-moderate risk).

  • Optional: Obtain a classification confirmation certificate from a Vietnamese classification entity.

✅ Step 2: Appoint a Local Authorized Representative (AR)

If you are a foreign manufacturer, you must:

  • Appoint a Vietnam-based company to act as the Authorized Representative (AR).

  • Provide a Letter of Authorization (LOA):

    • Must be notarized, legalized (consular), and translated into Vietnamese.

    • The AR must hold a valid medical device trading license.

✅ Step 3: Prepare the Application Dossier

Here’s what you need to include:

Required DocumentDetails
Letter of Authorization (LOA)Legalized + Vietnamese translation
Certificate of Free Sale (CFS)Issued by country of origin
ISO 13485 CertificateManufacturer’s QMS certificate
ASEAN CSDT DossierFollows ASEAN Common Submission Dossier Template
Product Description & Model ListImages, variations, product family
Classification FormDeclaring Class B risk level
Vietnamese Label & IFUMust comply with Vietnam MOH rules
Manufacturer & Product Info SheetLegal and technical profile

🔧 Tip: All documents must be translated into Vietnamese and submitted in PDF format.

✅ Step 4: Register Online via the MOH DMEC Portal

  • Go to the official portal: https://dmec.moh.gov.vn

  • AR logs in using their credentials

  • Select “Notification of Class B Devices”

  • Fill in the product and manufacturer information

  • Upload all supporting documents

  • Submit the application online

✅ Step 5: MOH Review Process

  • MOH will:

    • Verify documents and classification

    • Check for translation consistency and compliance

    • Request clarification if any errors/inconsistencies are found

⏱ Processing Time: ~10–15 working days if no issues

✅ Step 6: Receive Listing Number

  • Once accepted, MOH issues a product listing number (Số lưu hành).

  • This number:

    • Is valid indefinitely under Decree 98

    • Allows legal import and sale of the product in Vietnam

📌 Important Notes:

AreaDetails
LanguageAll documents must be in or translated into Vietnamese
ValidityUnder Decree 98, listing numbers for Class B do not expire
UpdatesChanges to AR, product info, or labeling require notification updates
LabelingMust comply with Circular 05/2022/TT-BYT (Vietnamese labeling rules)
CustomsListing number must be used in customs declarations

📂 Summary Checklist

✔ Classify product as Class B
✔ Appoint a Vietnam-based AR with LOA
✔ Prepare documents in ASEAN CSDT format
✔ Translate and notarize documents as required
✔ Submit online through https://dmec.moh.gov.vn
✔ Track and respond to MOH queries
✔ Receive and store product listing number

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Contact Us：

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


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