To register Class B medical devices with the Vietnam Ministry of Health (MOH), you must meet a specific set of regulatory and documentation requirements under Decree 98/2021/ND-CP and its amendment Decree 07/2023/ND-CP.

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

📌 1. Device Classification

The device must be classified as Class B (low to moderate risk) according to MOH classification rules.

Use classification criteria under Circular 05/2022/TT-BYT.

A classification confirmation from a licensed classification organization in Vietnam is optional but recommended.

📌 2. Authorized Representative (AR)

If you are a foreign manufacturer, you must:

Appoint a local entity (Vietnam-based company) to act as your Authorized Representative (AR).

The AR must be registered with proper business lines (such as medical device import, distribution).

📌 3. Document Requirements (Registration Dossier)

No.

Document

Notes

1    Application Form (Form No. 01 – Annex I, Decree 98)    Signed by AR    

2    Business License of AR    Company registration certificate    

3    Letter of Authorization from manufacturer to AR    Notarized and legalized    

4    Free Sale Certificate (FSC)    Issued by competent authority in country of origin; legalized    

5    ISO 13485 Certificate    Valid certificate of manufacturer    

6    Product Technical Dossier    See below for contents    

7    Product Labels and Instructions for Use (IFU)    Must be in Vietnamese and follow MOH requirements    

8    Classification Result (Optional)    From a Vietnamese licensed classification body    

📦 Product Technical Dossier Should Include:

Product description and intended use

Product specifications and performance claims

Label samples (English + Vietnamese)

Instructions for Use (IFU)

Packaging information

Risk analysis and safety data

Clinical evaluation or test data (if applicable)

📌 4. Online Submission

Registration is done online through the MOH Medical Device Portal:
🌐 https://dmec.moh.gov.vn

The AR is responsible for submission and account management.

📌 5. Labeling Requirements

Labels must include:

Name and model of the device

Manufacturer and AR name/address

Instructions in Vietnamese

Importer/distributor info

Labeling must comply with MOH guidance.

📌 6. Post-Registration Obligations

AR is responsible for:

Post-market surveillance

Reporting adverse events

Managing recalls or safety notices

Updating MOH on any changes (e.g., product, labeling, AR)

⏳ Registration Timeline:

Class B devices follow a notification process (not technical review)

If documents are complete: Approval in 5–10 working days

Listing Number (Số lưu hành) is valid indefinitely

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