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How long is the time cycle for applying for Class C medical device MDACS registration in Hong Kong? What are the review stages?
Release time：2025-06-25 15:45:55 The author: source:
The time cycle for applying for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) typically ranges from 3 to 9 months, depending on the completeness of the submission and the responsiveness of the applicant (usually the Local Responsible Person, or LRP). The process is not fixed by law, as MDACS is a voluntary system, but the Medical Device Division (MDD) follows a standard evaluation pathway.

The time cycle for applying for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) typically ranges from 3 to 9 months, depending on the completeness of the submission and the responsiveness of the applicant (usually the Local Responsible Person, or LRP).

The process is not fixed by law, as MDACS is a voluntary system, but the Medical Device Division (MDD) follows a standard evaluation pathway.

📆 Typical Timeframe for Class C MDACS Registration

StageDescriptionEstimated Duration
📝 Pre-submission PreparationDossier and form completion, LRP and manufacturer registration2–6 weeks (varies by applicant readiness)
📬 Submission to MDDSubmit Forms MD100, MD101, MD102 + technical dossier—
🔍 Administrative ScreeningMDD checks application completeness and document format2–4 weeks
📑 Technical EvaluationMDD reviews reference market approval, Essential Principles, safety, and performance documents2–4 months
❓ Clarification Phase (if needed)Applicant responds to MDD’s questions or requests for additional documents1–2 months (depending on response speed)
✅ Listing Decision & ConfirmationMDD issues listing confirmation and publishes on MDACS website~2 weeks

Total time: Usually 3 to 9 months, but can be faster (2.5 months) for highly standardized submissions or longer (9+ months) if documentation is incomplete or device is complex.

🔍 MDACS Review Stages in Detail

✅ 1. Administrative Check

  • MDD checks if all required forms are submitted (MD100, MD101, MD102)

  • Verifies whether all attachments are present:

    • Technical documents

    • CE/FDA certificates

    • IFU/labeling (in English or Chinese)

  • Ensures formatting and structure match GN-02 and GN-03

  • If incomplete: a Request for Further Information (RFI) will be sent

📌 Tips: Include a cover letter + table of contents; organize documents with bookmarks and folder hierarchy.

✅ 2. Technical Evaluation

  • MDD evaluates the device against the Essential Principles of Safety and Performance (GN-03)

  • Reviews:

    • Reference market approvals (CE, FDA, etc.)

    • Risk management documentation

    • Biocompatibility, EMC, electrical safety, software validation

    • Clinical evaluation or performance summary

    • Labeling accuracy and regulatory compliance

📌 Risk: If data is outdated, insufficient, or inconsistent with the CE/FDA dossier, MDD may pause the review and issue another RFI.

✅ 3. Clarification & Response Period

  • MDD sends RFI to LRP asking for:

    • Clarification on device model

    • Justification of clinical use

    • Updated documents or test reports

    • Explanation of discrepancies (e.g., IFU mismatch)

⏱ You typically have 2–4 weeks to respond, but extensions can be requested.

📌 Note: Prompt and thorough replies reduce overall review time.

✅ 4. Final Decision and Listing

If all criteria are satisfied:

  • MDD issues an official notification confirming successful listing

  • Device is added to the MDACS Device Listing Database

  • The LRP receives a registration confirmation letter and Hong Kong Medical Device Number (HKMD No.)

⏱ Factors That Can Delay the Process

FactorImpact
❌ Incomplete or disorganized dossierReturned or paused
❓ Delayed response to MDD’s RFIAdds weeks/months
📄 Invalid or expired CE/FDA certificatesListing rejected or suspended
🔄 LRP or manufacturer info changes mid-reviewRequires re-submission of forms
💬 Inconsistent labeling or claimsRequires additional justification

📝 Recommendations to Shorten the Review Cycle

  1. ✅ Ensure all forms (MD100, MD101, MD102) are complete and signed

  2. ✅ Match Hong Kong labeling with reference market labeling

  3. ✅ Use current versions of guidance documents (GN-01, GN-02, GN-03)

  4. ✅ Structure technical dossier with indexed sections (digital and print)

  5. ✅ Respond to MDD’s queries within 7–14 days

📌 Summary Table: Review Stages and Timeline

StageAction by ApplicantAction by MDDTimeframe
PreparationCompile dossier, register LRP/manufacturer—2–6 weeks
SubmissionSubmit MD102 + documentsAcknowledge receipt1–2 days
Screening—Check completeness2–4 weeks
Technical Evaluation—Assess conformity8–16 weeks
ClarificationSubmit response to RFIReview reply4–8 weeks
Final Listing—Issue listing notice~2 weeks

Would you like:

  • A timeline Gantt chart for tracking the MDACS registration process?

  • An editable template for tracking submission and review milestones?

  • Examples of RFIs from real Class C device reviews (anonymized)?

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