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What are the costs and time required for Class III medical device MDACS registration in Hong Kong?
Release time：2025-04-29 15:20:15 The author: source:
As of now, MDACS registration is voluntary and free of charge. The Medical Device Division (MDD) of Hong Kong's Department of Health does not charge fees for:

💰 Costs and ⏱️ Time Required for Class III Medical Device MDACS Registration in Hong Kong

💰 Costs

As of now, MDACS registration is voluntary and free of charge.
The Medical Device Division (MDD) of Hong Kong's Department of Health does not charge fees for:

  • Submitting the application,

  • Reviewing documents,

  • Listing the device.

✅ Total official fee = HKD 0

📌 Note: You may incur indirect costs, such as:

  • Fees for ISO 13485 certification (by accredited bodies),

  • Translation and document preparation (if needed),

  • Consultant or agent fees (if you use one for submission),

  • Local Responsible Person (LRP) service fees (if outsourced).

⏱️ Time Required

The processing time depends on the completeness of the documentation and the complexity of the device, but typically:

StageEstimated Duration
Document preparation2–6 weeks (varies by readiness)
MDD review and listing2–4 months (after submission)
Total time (average case)3–5 months

⏳ If MDD requests additional documents or clarifications, the process may be extended.

📌 Summary

ItemDetails
Official MDD FeesNone (HKD 0)
Processing Time2–4 months after submission
Total Time (including prep)~3–5 months
Indirect CostsVaries (ISO certs, consultants, LRP services, etc.)

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