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What is the cost and time required for Class IV medical device registration under Hong Kong MDACS?
Release time：2025-05-12 16:08:50 The author: source:
Registering a Class IV medical device under Hong Kong's Medical Device Administrative Control System (MDACS) involves a comprehensive process.

Registering a Class IV medical device under Hong Kong's Medical Device Administrative Control System (MDACS) involves a comprehensive process. Here's an overview of the costs and timeframes typically associated with this registration:

💰 Cost of Registration

  • Application Fee: As of January 2024, the Hong Kong Department of Health does not charge any application or processing fees for MDACS registration.

  • Additional Costs:

    • Local Responsible Person (LRP) Fees: If the manufacturer is based outside Hong Kong, appointing an LRP is mandatory. Fees for LRP services can range from HKD 10,000 to HKD 50,000 or more annually, depending on the service provider.

    • Document Translation: If your documentation is not in English or Chinese, translation costs will be incurred for official documents (e.g., labeling, Instructions for Use).

    • Post-Market Surveillance Costs: After the device is approved and listed, there are ongoing costs related to post-market surveillance, reporting, and compliance.grzan.cn

⏱️ Time Required for Registration

  • Official Processing Time: The Medical Device Division (MDD) aims to process applications within 12 weeks. asiaactual.com

  • Actual Processing Time: Due to high demand and other factors, actual review times can extend to 8–12 months or longer. Emergo Yul

  • Expedited Approval Scheme: For devices with approvals from at least two reference countries (e.g., US, EU, Japan), an Expedited Approval Scheme may shorten the review time. However, specific timelines for this scheme are not provided. asiaactual.com

📋 Summary

AspectDetails
Application FeeNone (as of January 2024)
LRP FeesHKD 10,000 to HKD 50,000+ annually
Translation CostsApplicable if documents are not in English or Chinese
Post-Market CostsOngoing surveillance and compliance expenses
Processing TimeOfficial: 12 weeks; Actual: 8–12 months or more
Expedited SchemeAvailable for devices with dual reference country approvals

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