中文|English
中文|English
What are the procedures for applying for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:36:16 The author: source:
The procedures for applying for Class B medical device registration with the Vietnam Ministry of Health (MOH) follow a streamlined product listing (notification) process under Decree 98/2021/ND-CP, which came into effect on January 1, 2022.

The procedures for applying for Class B medical device registration with the Vietnam Ministry of Health (MOH) follow a streamlined product listing (notification) process under Decree 98/2021/ND-CP, which came into effect on January 1, 2022.

Here’s a clear breakdown of the application procedure:

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

🔹 Step 1: Classify the Device

  • Use ASEAN Medical Device Classification Rules to confirm the product is Class B.

  • Optional: Request a classification certificate from a local licensed organization in Vietnam.

🔹 Step 2: Appoint an Authorized Representative (AR)

  • The foreign manufacturer must authorize a local Vietnamese company to act as the AR.

  • The AR must:

    • Have a medical device importation/distribution license

    • Be legally responsible for registration and post-market activities

    • Submit an LOA (Letter of Authorization), legalized and translated into Vietnamese

🔹 Step 3: Prepare the Application Dossier

Documents required for submission:

Required DocumentNotes
Letter of Authorization (LOA)Legalized + Vietnamese translation
Certificate of Free Sale (CFS)From country of origin
ISO 13485 CertificateManufacturer’s QMS certificate
ASEAN CSDT DossierASEAN Common Submission Dossier Template
Product Technical DocumentsBrochure, model list, images
Risk Classification FormDeclares Class B category
Label & Instructions for UseIn Vietnamese, compliant with MOH
Manufacturer Info SheetCompany details, address, contact
Testing Reports (if applicable)E.g. electrical safety, biocompatibility, EMC

🔹 Step 4: Submit the Application via MOH DMEC Portal

  • Register or log in to the DMEC online portal

  • Select “Product Notification – Class B”

  • Upload documents and submit the application

🔹 Step 5: MOH Review Process

  • MOH checks for:

    • Dossier completeness

    • Legal compliance (LOA, CFS, ISO 13485)

    • Vietnamese labeling accuracy

  • If compliant: proceed to issue listing number

  • If not: request for clarification/correction

⏱️ Processing Time: Around 10–15 working days if complete and correct

🔹 Step 6: Receive Product Listing Number

  • MOH issues the Số lưu hành (Listing Number) online

  • This number is required for:

    • Import customs clearance

    • Sales and distribution in Vietnam

📌 Summary of the Procedure

  1. ✔ Classify device as Class B

  2. ✔ Appoint a Vietnam-based Authorized Representative

  3. ✔ Prepare a compliant technical & legal dossier

  4. ✔ Submit application on https://dmec.moh.gov.vn

  5. ✔ Wait for MOH review (10–15 working days)

  6. ✔ Receive listing number for legal sale/import

Would you like:

  • A PDF checklist of required documents?

  • A sample ASEAN CSDT template?

  • Help with choosing a reliable AR in Vietnam?

cdc-IFpQtennlj8-unsplash(2).jpg

Contact Us：

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


Last one: How to register and apply for Class B medical device registration with the Vietnam MOH?
The next one: How to handle Class B medical device registration with the Vietnam MOH?
return