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What rules and requirements must be followed after applying for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:32:50 The author: source:
After applying for Class B medical device registration with the Vietnam Ministry of Health (MOH), there are important rules and requirements to follow during and after the application process to ensure compliance and avoid delays or penalties.

After applying for Class B medical device registration with the Vietnam Ministry of Health (MOH), there are important rules and requirements to follow during and after the application process to ensure compliance and avoid delays or penalties.

✅ Post-Application Rules & Requirements (Class B – Vietnam MOH)

🔁 1. Monitor Application Status

  • Applications for Class B are submitted online via the MOH Portal (https://dmec.moh.gov.vn).

  • The applicant (usually the Authorized Representative or AR) must:

    • Check for MOH feedback or missing documents

    • Respond promptly to any corrections or updates requested

📥 2. Prepare for Possible MOH Requests

  • The MOH may request clarification or additional documents, such as:

    • Supplementary test reports

    • Clarification of technical specs

    • Labeling or translation corrections

  • You must respond within the timeframe specified (typically 10 working days).

📑 3. Maintain Accurate and Complete Records

  • Ensure that all documents submitted:

    • Are consistent across files (device name, manufacturer, model, specs)

    • Match the actual product being sold/imported

  • Keep a copy of all:

    • Legalized and translated documents

    • Application files and online confirmation

    • Communication with MOH

🚫 4. Do Not Import or Market the Device Until Approval

  • No marketing or importation is allowed before the listing number is officially issued.

  • Premature promotion or sales may result in:

    • Fines

    • Rejection of application

    • MOH blacklisting of AR or product

⚠️ 5. Avoid Common Mistakes

MistakeRisk
Incomplete documentsApplication rejection
Incorrect Vietnamese translationMOH request for resubmission
Label/IFU not matching submissionCustoms seizure or recall
Using unauthorized ARLegal violation and application invalid

📦 6. Prepare for Post-Approval Obligations

Once your application is approved, the AR must be ready to:

  • Handle customs procedures using the MOH listing number

  • Monitor post-market safety (adverse event reporting, complaint handling)

  • Comply with labeling regulations (Vietnamese language, listing number, AR details)

🛑 7. No Changes Allowed During Review

  • Do not change product specifications, AR, or documentation while the application is under review.

  • If any changes are needed, withdraw the application and resubmit.

📌 Summary: Key Rules After Submitting Class B Registration

RuleDescription
Wait for MOH approvalNo importation or marketing beforehand
Monitor MOH portalRespond to requests for clarification promptly
Keep docs consistentMatch info across all files, labels, IFU
Maintain communicationAR should be responsive and accurate
No changes mid-reviewResubmit if necessary

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