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What should be noted after obtaining approval for Class B medical device registration with the Vietnam MOH?
Release time：2025-04-07 14:30:10 The author: source:
After obtaining approval (i.e., the Medical Device Listing Number) for a Class B medical device with the Vietnam Ministry of Health (MOH), there are several important post-approval responsibilities and precautions to ensure ongoing compliance.

After obtaining approval (i.e., the Medical Device Listing Number) for a Class B medical device with the Vietnam Ministry of Health (MOH), there are several important post-approval responsibilities and precautions to ensure ongoing compliance.

✅ What to Note After Approval of Class B Medical Device (Vietnam MOH)

1. 📜 Maintain Validity of Registration

  • Class B devices are exempt from expiration under Decree 98/2021/ND-CP.

  • However, the listing number remains valid only if product details remain unchanged.

  • Re-notification is required if:

    • Manufacturer changes

    • Product name/model changes

    • Labeling or intended use changes

    • Distributor/Authorized Representative (AR) changes

2. 📦 Labeling Compliance

  • Product must be labeled in Vietnamese per MOH requirements.

  • Label must match exactly the information in the registered dossier (Listing Number, manufacturer, model, etc.).

  • Include:

    • Device name

    • Listing number (from MOH)

    • Manufacturer

    • AR in Vietnam with contact info

    • Production date, lot/batch number, expiration (if applicable)

3. 🧾 Importation Requirements

  • When importing, the customs broker must present:

    • MOH Listing Number

    • Valid contract with AR

    • Vietnamese label and IFU

    • Manufacturer’s invoice

  • Customs may request additional documents or testing if there’s suspicion of product inconsistency.

4. 🔄 Post-market Surveillance (PMS) Obligations

Your Authorized Representative (AR) is responsible for:

TaskNotes
Adverse event reportingReport serious incidents to MOH within 10 days
Corrective action trackingMust document and notify MOH if product recall or CAPA is required
Customer complaintsAR must record and resolve complaints
Annual reportingNot mandatory for Class B, but recommended to maintain traceability

5. 📝 Maintain Documentation

  • Keep a full copy of the technical dossier, translated IFU, and legal certificates available in case of inspection.

  • AR and importer must maintain distribution records for traceability.

6. 🚫 Avoid Non-compliance Risks

You may face fines, product seizure, or listing cancellation if:

  • Products differ from those registered

  • Vietnamese label or IFU are incorrect

  • You fail to report incidents or changes

  • You use misleading advertising or make unapproved claims

7. 🔁 Change Management

  • If any of the following change, notify the MOH and re-register or update the listing:

    • Manufacturer name/address

    • Brand or model name

    • Risk classification

    • Indications for use

📌 Final Tips

TaskRecommendation
Monitor regulatory updatesDecree 98/2021 is evolving — stay updated
Work closely with your ARThey're responsible for compliance on your behalf
Keep digital copies organizedEspecially certificates, testing, labeling, and MOH responses

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