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What conditions must be met to apply for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:27:34 The author: source:
To apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), several regulatory, technical, and legal conditions must be met in accordance with Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.

To apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), several regulatory, technical, and legal conditions must be met in accordance with Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.

✅ Conditions for Registering a Class B Medical Device in Vietnam

1. 📦 Device Classification Must Be Class B

  • The product must be confirmed as Class B (moderate risk).

  • You may:

    • Self-classify the device, or

    • Obtain a classification result from a licensed Vietnamese classification agency (recommended).

2. 🏢 Authorized Representative (AR) in Vietnam

  • The applicant must be a Vietnam-based legal entity.

  • This AR must:

    • Have a valid business license that includes medical device importation or distribution.

    • Be legally authorized by the foreign manufacturer via a Letter of Authorization (LOA).

    • Be responsible for product quality, post-market surveillance, and recalls in Vietnam.

3. 📃 Required Documents Must Be Complete

You must prepare and submit a complete dossier, including:

DocumentCondition
Application Form (Form 01)Must be properly filled, signed, and stamped by AR
AR’s Business LicenseMust show medical device activity
Letter of Authorization (LOA)Notarized + legalized + Vietnamese translation
Free Sale Certificate (FSC)Legalized + translated; shows product is approved in origin country
ISO 13485Valid certificate from manufacturer’s QMS
Technical FileComplete with specifications, risks, IFU, labels
Vietnamese Labels & IFUMust meet MOH format and language requirements
Classification ResultOptional but strongly recommended for clarity

4. 🌍 Product Must Be Approved in Country of Origin

  • The Free Sale Certificate (FSC) must prove the device is legally sold in the manufacturer’s home country.

  • The FSC must be:

    • Issued by the competent health authority

    • Legalized at the Vietnamese embassy/consulate

    • Translated into Vietnamese

5. 📥 Online Registration via MOH Portal

  • Application must be submitted through the official MOH system:

  • AR must have a valid account on the portal.

6. 🏷 Labeling and IFU Must Be in Vietnamese

  • Product packaging and instructions must comply with MOH labeling regulations:

    • Product name, model

    • Manufacturer name

    • Country of origin

    • AR information

    • Date of manufacture, shelf life

    • Storage instructions, usage warnings

⚠️ Other Conditions to Note

AreaCondition
🌐 SubmissionMust be done online—no paper submission is accepted.
🕵️‍♂️ Legal ResponsibilityAR is responsible for post-market obligations, including incident reporting.
🔄 Change ManagementAny changes to product, labeling, or AR must be updated in the MOH system.

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