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How to handle Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:34:59 The author: source:
To handle Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a structured process defined by Decree 98/2021/ND-CP and supporting regulations. Class B devices (low-moderate risk) follow a notification (listing) process, not a full evaluation, making it more straightforward than Class C/D registration.

To handle Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a structured process defined by Decree 98/2021/ND-CP and supporting regulations. Class B devices (low-moderate risk) follow a notification (listing) process, not a full evaluation, making it more straightforward than Class C/D registration.

✅ Step-by-Step Guide to Handling Class B Registration

🔹 1. Confirm Device Classification

  • Use ASEAN/GHTF classification rules to confirm your product is Class B.

  • Classification by a licensed Vietnamese organization is recommended (though not mandatory).

🔹 2. Appoint a Legal Authorized Representative (AR) in Vietnam

  • The AR must:

    • Be a Vietnamese entity with a business license for medical devices.

    • Hold importation and distribution rights.

    • Be responsible for post-market surveillance and regulatory compliance.

  • A Letter of Authorization (LOA) from the manufacturer is required (notarized, legalized, and translated).

🔹 3. Prepare the Technical & Legal Dossier

The dossier should include:

DocumentNotes
Letter of Authorization (LOA)Legalized + translated into Vietnamese
Free Sale Certificate (CFS)From the country of origin
ISO 13485 certificateValid QMS certificate of manufacturer
Technical FileFollow ASEAN CSDT format
Label & IFU (Vietnamese)As per Circular 05/2022/TT-BYT
Product Description, Model ListInclude images/specs
Risk Classification DocumentSigned by the manufacturer or AR
Other supporting certificatesE.g., FDA, CE (optional but helpful)

🔹 4. Submit Registration via DMEC Portal

  • Log in to the MOH online platform: https://dmec.moh.gov.vn

  • Create an account or use your AR’s account.

  • Upload documents and complete product info form.

  • Choose "Class B – Product Listing".

🔹 5. Track and Respond to MOH Review

  • MOH will:

    • Review documentation for accuracy and compliance.

    • May request corrections or additional documents.

  • Processing time: typically 10–15 working days, if no corrections are needed.

🔹 6. Receive the Listing Number

  • If approved, MOH issues a product listing number (Số lưu hành).

  • This number allows legal importation and distribution of the product in Vietnam.

📌 Important Considerations

AreaDetails
🔄 UpdatesAny change in AR, manufacturer, model, or intended use may require an update or re-registration.
🛃 Customs ClearanceListing number must be provided for customs clearance of imports.
📢 Advertising & LabelingMust comply with Vietnam MOH rules; advertising requires separate approval.
📈 Post-market dutiesAR is responsible for vigilance, incident reporting, and compliance audits.

✅ Summary Checklist

  • Confirm Class B risk class

  • Appoint legal AR with LOA

  • Prepare ASEAN CSDT technical dossier

  • Translate and notarize all necessary documents

  • Submit online via DMEC portal

  • Track progress and respond to MOH

  • Receive listing number for legal import/sale

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Contact Us：

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


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