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How long does it take to obtain registration for Class B medical devices with the Vietnam MOH?
Release time：2025-04-07 14:43:33 The author: source:
The typical processing time to obtain registration for Class B medical devices with the Vietnam Ministry of Health (MOH) is:

The typical processing time to obtain registration for Class B medical devices with the Vietnam Ministry of Health (MOH) is:

🕒 Estimated Timeframe

StageEstimated Time
Online submission review1–3 working days (initial check)
MOH evaluation and approval7–15 working days (if documents are complete and valid)
Issuance of listing number (Số lưu hành)Included in above; via DMEC portal

✅ Total time (best case): 10–15 working days
⏳ Possible delay (if incomplete/missing info): Can extend to 30+ working days if clarification is needed.

✅ What Affects the Timeline?

FactorImpact
🗂 Completeness of applicationMissing or incorrect documents delay approval
📋 Correct classificationMisclassification (e.g., C instead of B) may cause rejection
🧾 Language complianceDocuments must be in Vietnamese or translated
📌 MOH workloadHigh submission volume can slow processing
🧑‍💼 Authorized Representative (AR)Must have valid import license and registration account

📍 Summary

ItemDetails
Normal processing time~10–15 working days
Platformhttps://dmec.moh.gov.vn
Fastest pathSubmit complete and compliant documents via AR
Delays caused byErrors, incomplete documents, or MOH requests for clarification

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Contact Us：

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


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