Required Documents for Class B Medical Device Registration (Vietnam MOH)

1. ✅ Application Form (Form No. 01 – Annex I, Decree 98/2021)

• Must be filled out completely.

• Signed and stamped by the Authorized Representative (AR).

• Format: PDF

2. ✅ Business Registration Certificate of the AR

• Must show medical device importation/distribution as a permitted business activity.

• Certified true copy in Vietnamese.

• Format: PDF

3. ✅ Letter of Authorization (LOA)

• Issued by the foreign manufacturer to the Vietnam-based AR.

• Clearly states the authorization for registration and post-market responsibility.

• Must be:

  • Notarized

  • Legalized at the Vietnamese embassy/consulate

  • Translated into Vietnamese

• Format: PDF

4. ✅ Free Sale Certificate (FSC)

• Issued by the competent authority in the country of origin.

• Proves the product is legally marketed there.

• Must be:

  • Notarized

  • Legalized

  • Translated into Vietnamese

• Format: PDF

5. ✅ ISO 13485 Certificate

• Issued to the manufacturer of the product.

• Proves compliance with international quality management systems for medical devices.

• English or Vietnamese accepted; translation recommended if needed.

• Format: PDF

6. ✅ Product Technical Dossier

Should include:

• Device description and intended use

• Technical specifications

• Materials and components

• Risk management summary

• Manufacturing process overview

• Test reports or performance data (if applicable)

• Labeling content

• Instructions for Use (IFU)

🗂 Tip: MOH does not require the full Common Technical Document (CTD), but organize your file like a mini technical summary. Translate key sections to Vietnamese.

7. ✅ Labels and Instructions for Use (IFU)

• Must be provided in Vietnamese.

• Label must include:

  • Product name, model

  • Manufacturer name and country

  • AR info (name, address, contact)

  • Date of manufacture and expiry (if applicable)

  • Storage conditions, warnings

• IFU should explain usage, precautions, and contact info.

8. ✅ Classification Result (Optional but recommended)

• Issued by a licensed Vietnamese classification organization.

• Confirms your device is Class B.

• Helps avoid disputes or reclassification by MOH.

• Format: PDF

📦 How to Prepare the Application Files

🔹 Step 1: Translate non-Vietnamese documents

• FSC, LOA, labels, and IFU must be translated into Vietnamese.

• Use a certified translation service for legal documents.

🔹 Step 2: Scan and name files clearly

• Ensure all documents are scanned in high resolution (PDF).

• Use meaningful filenames like:
  01_ApplicationForm.pdf, 03_LOA_legalized.pdf, 06_TechnicalDossier.pdf

🔹 Step 3: Upload to MOH Portal

• Access: https://dmec.moh.gov.vn

• Log in with AR account

• Fill in product data, upload documents, and submit for listing

📌 Summary Checklist

Would you like:

• A downloadable document checklist template?

• A label and IFU template in Vietnamese?

• Guidance on how to structure the technical dossier?

Contact Us：

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