Your Local Responsible Person (LRP) and Market Access Partner

Entering the Hong Kong medical device market requires navigating a specific regulatory framework. As your authorized Local Responsible Person (LRP), Gainwell Global acts as your on-the-ground compliance partner, bridging the gap between your products and the Hong Kong Medical Device Administrative Control System (MDACS).

 

Our LRP services include:

– Acting as the official Local Responsible Person for your devices in Hong Kong

– Preparing and submitting MDACS listing applications (Class II, III, and IV devices)

– Post-market surveillance and adverse event reporting

– Liaising with the Hong Kong Department of Health on your behalf

– Ongoing regulatory monitoring and compliance updates

 

We provide a clear, step-by-step pathway for international manufacturers to place their devices in the Hong Kong market with confidence.

 

Your Assured Compliance Partner in Hong Kong

As your officially registered Local Responsible Person (LRP), Gainwell Global undertakes the defined regulatory responsibilities as required by the Hong Kong Medical Device Administrative Control System (MDACS). This includes, but is not limited to, maintaining your device listing with the Department of Health, acting as the primary point of contact for all regulatory communications, implementing post-market surveillance and vigilance reporting, and ensuring your ongoing compliance with local requirements. Product quality and safety responsibilities remain with the manufacturer as specifically defined in our service agreement.

 

By appointing our experienced team as your LRP, you transfer these critical regulatory obligations to a dedicated, on-the-ground partner, allowing you to focus on your core business while we ensure your products remain compliantly active in the Hong Kong market.

 

Key Reference Documents

Our compliance services are guided by the regulatory framework established by the Hong Kong Department of Health. The following official documents inform our service scope and quality management. You may download them here for your reference:

 

GN-01: Overview of the Medical Device Administrative Control System

TR-003: Classification of Medical Devices

TR-006: Classification of In Vitro Diagnostic Medical Devices

MD-CCL-C: Essential Principles of Safety and Performance – Medical Devices

MDIVD-CCL-C: Essential Principles of Safety and Performance – IVD Medical Devices

 

Below are some of the reference documents. For the complete set, please contact us via the “Contact Us“ page.