The processing time for Class B medical device registration with the Vietnam Ministry of Health (MOH) is typically:

⏱️ Processing Time for Class B Medical Devices (Vietnam MOH)

🔔 Note: Delays may occur if documents are incomplete, translations are inaccurate, or MOH needs additional verification.

🔍 MOH Review Steps for Class B Devices

Step 1: Online Submission

• Submit the full dossier via the DMEC MOH Portal: https://dmec.moh.gov.vn

Step 2: Initial Check for Completeness

• MOH screens:

  • Required documents uploaded

  • File formats and naming correct

  • Consistency across product info, manufacturer, labels

Step 3: Detailed Review

• MOH checks:

  • Classification validity (must match Class B)

  • Labeling in Vietnamese and packaging compliance

  • Certificates: CFS, ISO 13485, LOA authenticity

  • Basic safety, conformity with ASEAN/GHTF format

Step 4: Clarification Request (if needed)

• MOH may request:

  • Corrected/updated documents

  • Clarification on specs, labeling, translation

• Applicant must respond within 10 working days

Step 5: Issuance of Listing Number

• If all is compliant, MOH issues:

  • Số lưu hành (product listing number)

  • Confirmation posted on DMEC portal

📌 Important Notes

• Class B devices go through a notification process, not full approval.

• No clinical data or safety testing by MOH is required at this stage.

• Ensure Vietnamese translations are accurate and consistent to avoid rejections.

• Use a reliable Authorized Representative (AR) to track the submission and respond to requests quickly.

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