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What are the procedures and standards for periodic updates of Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:33:20 The author: source:
For Class B medical devices registered with the Vietnam Ministry of Health (MOH), while the listing number does not expire, there are still procedures and standards for making periodic updates or changes to ensure regulatory compliance under Decree 98/2021/ND-CP and related guidelines.

For Class B medical devices registered with the Vietnam Ministry of Health (MOH), while the listing number does not expire, there are still procedures and standards for making periodic updates or changes to ensure regulatory compliance under Decree 98/2021/ND-CP and related guidelines.

✅ Is Periodic Renewal Required?

  • 🔹 No renewal is required for Class B device listing numbers – they are valid indefinitely as long as there are no changes to the registered information.

  • 🔹 However, updates or re-registration are required if certain information changes.

🔁 Situations That Require Updates or Modifications

Type of ChangeAction Required
🔄 Change of Authorized Representative (AR)Submit new LOA and re-register under new AR
🏭 Change in Manufacturer or production siteNotify MOH or re-register, depending on the extent
🛠 Change in device name, model, or classificationMust update or re-register
💊 Change in intended use or indicationsRe-assessment of classification and re-registration
📦 Change in labeling, IFU, packagingUpdate dossier and label samples
🔍 Updates to technical specs or safety/performance standardsSubmit updated technical documents

🛠️ Update Procedures with Vietnam MOH

1. Log into MOH DMEC Portal

2. Prepare Required Documents

  • Updated or new versions of:

    • Letter of Authorization (if AR changes)

    • Technical documents showing revised specs

    • Updated Vietnamese label and IFU

    • Classification documents (if risk class may change)

    • Relevant international certificates (e.g., FSC, ISO 13485)

3. Official Submission

  • Submit application under the appropriate category:

    • “Cập nhật thông tin” (Information Update)

    • “Đăng ký lại” (Re-registration), if required by the type of change

4. MOH Review

  • MOH may:

    • Approve the change directly

    • Request additional documents

    • Require full re-application if changes are substantial

📋 Standards to Follow During Updates

AreaRelevant Standards
LabelingMust meet Vietnamese labeling regulations – Circular 05/2022/TT-BYT
Technical fileComply with ASEAN CSDT format and ISO standards (e.g., ISO 14971, ISO 13485)
Safety/performanceUse IEC/ISO standards: IEC 60601 (electrical safety), ISO 10993 (biocompatibility), etc.
Post-market obligationsEnsure reporting per Circular 19/2021/TT-BYT and Decree 98/2021

📌 Best Practices

  • Maintain version control of all technical and legal documents.

  • Work with a qualified local Authorized Representative for timely updates.

  • Avoid using or marketing any updated product until changes are officially approved.

  • Ensure consistency across all files: registration info, labels, packaging, and marketing materials.

Would you like:

  • A sample update submission checklist?

  • A template for a change notification to MOH?

  • Guidance on when a full re-registration is needed?

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


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