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What is the timeline for Class D medical device MDACS registration in Hong Kong?
Release time：2025-07-08 15:48:08 The author: source:
The timeline for Class D medical device MDACS registration in Hong Kong typically ranges from 4 to 9 months, depending on the completeness of the submission, the complexity of the device, and how quickly the applicant and their Local Responsible Person (LRP) respond to the Medical Device Division (MDD) of the Department of Health.

The timeline for Class D medical device MDACS registration in Hong Kong typically ranges from 4 to 9 months, depending on the completeness of the submission, the complexity of the device, and how quickly the applicant and their Local Responsible Person (LRP) respond to the Medical Device Division (MDD) of the Department of Health.

Since Class D devices represent the highest-risk category, the review is more rigorous, especially for clinical evidence, risk management, and post-market surveillance systems.

⏱️ Estimated Timeline for Class D MDACS Registration

PhaseActivityEstimated Duration
1. PreparationAppoint LRP, prepare documents1–3 months
2. SubmissionOnline submission via MDIS1 week
3. Administrative ScreeningMDD checks format, completeness2–4 weeks
4. Technical ReviewIn-depth review of safety, efficacy, risk, testing3–6 months
5. Request for Clarification (if any)Response from applicant2–8 weeks per round
6. Final Decision & ListingIssuance of MDACS listing number1–2 weeks

✅ Total estimated timeline: 4–9 months

⏳ For complex or novel devices (e.g. software with AI, new materials, first-of-its-kind IVD), the process may take up to 12 months.

🔍 What Can Affect the Timeline?

FactorImpact
✅ Complete & well-organized dossierSpeeds up review
❌ Missing or inconsistent documentsDelays, clarification rounds
✅ Valid CE/FDA/TGA approvalReduces depth of technical review
❌ Poor risk analysis or clinical dataTriggers additional questions
✅ Timely LRP responses to MDDAvoids long pauses in review
✅ Properly labeled, translated IFU/labelingMinimizes back-and-forth

📦 Typical Documents Reviewed During Timeline

  • ISO 13485 certificate (QMS)

  • CE certificate / FDA 510(k) / TGA approval

  • Essential Principles Checklist (GN-01 / GN-02)

  • Clinical Evaluation Report

  • Risk Management File (ISO 14971)

  • Biocompatibility, electrical safety, EMC test reports

  • IFU and device labeling

  • Post-market surveillance and FSCA procedures

📬 Example Timeline Breakdown (Well-Prepared Applicant)

Date RangeEvent
Jan–FebLRP appointment and document preparation
March 1MDACS application submitted via MDIS
March 15Admin screening completed
April–JulyTechnical review by MDD
Aug 1MDD issues RFC (request for clarification)
Aug 15Applicant submits response
Sept 1Final review and approval
Sept 10Listing number issued (device approved)

📌 Total: ~6 months

🛠️ Tips to Shorten the Timeline

  1. ✅ Use a professional LRP with MDACS experience

  2. ✅ Submit a clean and indexed technical file

  3. ✅ Include strong clinical and risk management evidence

  4. ✅ Translate labeling into Traditional Chinese

  5. ✅ Respond to MDD clarifications within 10 working days

  6. ✅ Ensure all certificates (e.g. ISO, CE) are valid and relevant

📌 Reminder

Although MDACS is voluntary, listing is often required for public hospital tenders, clinical trials, and import clearance.

After approval, the listing is valid for 5 years, and the renewal process should begin at least 6 months before expiry.

Would you like a Gantt chart template or a customized timeline tracker for Class D MDACS registration based on your device type and current progress?


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