To apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a structured process through the online MOH medical device portal. Here's a clear step-by-step guide on how and where to apply:

📝 How to Apply for Class B Medical Device Registration

✅ Step 1: Classify the Device

• Confirm that the device falls under Class B (moderate risk).

• You may obtain an optional classification certificate from a licensed Vietnamese organization.

✅ Step 2: Appoint an Authorized Representative (AR)

• Must be a Vietnamese-registered legal entity with medical device importation/distribution in its business scope.

• Only the AR can submit the application on behalf of the foreign manufacturer.

✅ Step 3: Prepare the Registration Dossier

Prepare the following documents (in PDF format):

✅ Step 4: Register and Submit on the MOH Portal

🔗 Online Platform:

• 🌐 Website: https://dmec.moh.gov.vn

📌 Portal Actions:

• Create an account (AR only)

• Log in and access “Device Listing” for Class B

• Fill in product and company information

• Upload the required documents

• Submit the application

✅ Step 5: MOH Review and Approval

• For Class B, the registration follows a notification process:

  • If the dossier is complete, a Listing Number is automatically issued within 5–10 working days.

  • No technical review is required for Class B.

✅ Step 6: Begin Importation and Sales

Once the Listing Number is issued, you can:

• Import the device into Vietnam

• Distribute and market the product

📍 Where to Handle the Registration

All actions are completed through the official MOH online platform:

🔗 MOH Medical Device Portal:
https://dmec.moh.gov.vn

📌 Note: All applications, updates, approvals, and tracking are handled entirely online. No physical submission is required.

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