The time frame for applying for Class D medical device registration under MDACS (Medical Device Administrative Control System) in Hong Kong varies depending on the completeness of the submission, device complexity, and the responsiveness of the applicant/LRP during the review. Since Class D devices are high-risk (e.g., implantables, life-supporting devices, high-sensitivity IVDs), the review process is more rigorous than lower classes.

Below is a detailed explanation of the typical registration timeline and the review process phases for Class D medical devices in Hong Kong.

🕒 MDACS Class D Registration – Estimated Time Frame

✅ Average total timeline: 4 to 9 months
❗ For novel or incomplete applications, 10–12 months is possible.

🔍 What Affects the Timeline?

🔬 MDACS Class D Review Process – Phase by Phase

Phase 1: Administrative Screening (2–4 weeks)

• MDD checks if:

  • LRP is correctly appointed

  • All forms are complete and signed

  • Required documents are uploaded in MDIS

  • File format and language requirements are met

✅ Outcome:

• Accept for detailed review

• Or return for resubmission if incomplete

Phase 2: Technical Documentation Review (2–4 months)

MDD reviews compliance with:

• Essential Principles of Safety and Performance

• Quality Management System (ISO 13485 certificate)

• Foreign market authorization (e.g., CE, FDA, TGA)

• Test reports: biocompatibility, electrical, EMC, software validation

• Clinical evaluation report (if required)

• Risk management (ISO 14971 framework)

• Labeling and Instructions for Use (IFU) per GN-07

✅ Outcome:

• Proceed to next phase if compliant

• Or issue Request for Clarification (RFC) for deficiencies

Phase 3: Request for Clarification (RFC) Handling (2–8 weeks per round)

• Applicant/LRP is asked to:

  • Provide missing or updated documents

  • Clarify test results, labeling content, intended use

  • Address gaps in risk or clinical evaluation

⏱ MDD typically allows 10–30 calendar days to respond per RFC.

✅ Tip: Timely, accurate responses reduce the number of review cycles.

Phase 4: Final Assessment and Listing Decision (2–4 weeks)

• If all documents are satisfactory:

  • MDD issues Letter of Acceptance

  • Device is listed on the MDACS website

  • A Listing Number (MDxxxxxx) is assigned

• LRP receives official notification

✅ Device may now be marketed, distributed, and used in Hong Kong.

🧾 Summary Timeline Breakdown

🧠 Important Notes

• No fixed statutory deadline: Since MDACS is a voluntary system, the Department of Health has no legally mandated timeline for review.

• High-quality technical files may receive faster approval.

• Class D reviews are prioritized if related to public tenders or hospital applications (based on MDD discretion).

• MDACS registration is valid for 5 years; renewal should start at least 6 months before expiration.

✅ How to Ensure a Fast and Smooth Review

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