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How long does it take to obtain Class C medical device MDACS registration in Hong Kong?
Release time：2025-06-25 15:51:02 The author: source:
Obtaining Class C medical device registration under the MDACS (Medical Device Administrative Control System) in Hong Kong typically takes 3 to 9 months, depending on several factors such as the completeness of documentation, the device’s complexity, and how quickly the applicant responds to the authority’s requests for clarification.

Obtaining Class C medical device registration under the MDACS (Medical Device Administrative Control System) in Hong Kong typically takes 3 to 9 months, depending on several factors such as the completeness of documentation, the device’s complexity, and how quickly the applicant responds to the authority’s requests for clarification.

⏳ Estimated Timeframe for Class C MDACS Registration

PhaseActivityEstimated Duration
🔍 Pre-Submission PreparationAppoint Local Responsible Person (LRP), gather certificates, prepare dossier2–6 weeks
📝 Application SubmissionSubmit Forms MD100, MD101, MD102 and all technical documents—
📋 Administrative ScreeningMDD checks completeness and format of submitted documents2–4 weeks
🧪 Technical EvaluationMDD reviews technical file, certificates, risk data, and clinical info8–16 weeks
❓ Request for Information (RFI)If needed, MDD requests clarification or missing information+2–6 weeks depending on response
✅ Final Decision & ListingMDD issues confirmation and assigns HKMD number~1–2 weeks after approval

📌 Total Estimated Time: 3 to 9 Months

🔹 Best-case scenario (well-prepared, complete dossier): ~3–4 months
🔹 Typical timeframe (minor clarifications needed): ~5–6 months
🔹 Complex cases (incomplete info or multiple RFIs): 7–9+ months

🔎 What Affects the Timeline?

FactorImpact on Timeline
✅ Complete and well-organized documentationSpeeds up administrative and technical review
❌ Missing or inconsistent dataTriggers clarification requests, causing delay
🕐 Slow response to MDD queriesExtends timeline significantly
📋 High-risk or innovative deviceMay require deeper review and more supporting evidence
🌍 Uncommon reference marketIf approval is not from standard markets (EU/US/Australia/Canada), MDD may take longer

🛠 Tips to Shorten the Process

  1. ✅ Ensure documents follow MDACS Guidance Notes:

    • GN-01 (classification)

    • GN-02 (submission format)

    • GN-03 (essential principles checklist)

  2. 📦 Prepare a complete technical dossier, including:

    • CE/FDA certificates

    • ISO 13485 certificate

    • Risk assessment (ISO 14971)

    • Clinical evidence

    • Instructions for use (IFU) and labeling (English or Chinese)

  3. 💬 Respond quickly and completely to any Request for Further Information (RFI)

  4. 📂 Organize files clearly (bookmarks, indexes, digital copies)

📎 Conclusion

It usually takes 3 to 9 months to obtain Class C MDACS registration in Hong Kong, depending on the application’s quality, documentation completeness, and applicant responsiveness during review stages.

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