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How long is the registration cycle for Class C medical device MDACS in Hong Kong?
Release time：2025-06-25 15:49:11 The author: source:
The registration cycle for Class C medical devices under Hong Kong’s MDACS (Medical Device Administrative Control System) typically takes 3 to 9 months, depending on the quality of the application, responsiveness to authority queries, and complexity of the device.

The registration cycle for Class C medical devices under Hong Kong’s MDACS (Medical Device Administrative Control System) typically takes 3 to 9 months, depending on the quality of the application, responsiveness to authority queries, and complexity of the device.

🕒 Typical Registration Timeframe Breakdown

StageTaskEstimated Duration
📝 PreparationCompile technical dossier, gather certificates, register LRP and manufacturer2–6 weeks
📬 SubmissionSubmit Forms MD100, MD101, MD102 with all documentation—
🔍 Administrative ScreeningMDD checks completeness of submission2–4 weeks
📑 Technical EvaluationMDD reviews conformity, technical data, clinical evidence8–16 weeks
❓ Clarification/Query HandlingMDD issues request(s) for further information (RFI)2–6 weeks (depends on your response)
✅ Final ListingDevice is listed, HKMD number assigned~2 weeks

🧮 Total Typical Cycle:

12 to 36 weeks
= ~3 to 9 months

📌 Notes on Review Stages

🔸 Administrative Screening (2–4 weeks)

  • Ensures forms (MD100, MD101, MD102) and documents follow required format (GN-02, GN-03)

  • Missing or incomplete documentation delays this step

🔸 Technical Review (2–4 months)

  • Covers:

    • Essential Principles compliance (per GN-03)

    • Reference market approval verification

    • Clinical and performance evidence

    • Risk and labeling evaluation

  • The more complex or innovative your device, the longer this review may take

🔸 RFIs (Request for Further Information)

  • If any information is unclear or missing, MDD will issue formal queries

  • Delay depends on your response speed and completeness

⚠️ Factors That May Lengthen the Registration Cycle

CauseImpact
❌ Incomplete dossierImmediate delay until corrected
🔄 Poorly organized filesMay trigger clarification requests
💬 Slow RFI responsesAdds weeks or months
🧪 Lack of clinical evidenceMay lead to rejection or major revision
🖨 Outdated or missing certificatesCould halt review process

📊 Real-World Experience

Submission QualityApproval Time
📁 Well-prepared, standard Class C device~3–4 months
⚠️ Average-quality dossier, minor RFI~5–6 months
❌ Multiple RFIs or missing documents7–9+ months

🔄 Post-Listing Validity

  • MDACS listing has no fixed expiry, but:

    • Must be updated when certificates, labeling, IFUs, or LRP change

    • LRP must handle post-market surveillance and reporting

✅ Tip: How to Shorten the Cycle

ActionBenefit
Use MDACS guidance (GN-01, GN-02, GN-03)Avoid formatting and content errors
Submit complete and clear documentationSpeeds up administrative screening
Respond to RFI within 1 weekKeeps process on track
Pre-organize dossier with indexes/bookmarksSimplifies reviewer’s job

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