The Medical Device Administrative Control System (MDACS) in Hong Kong is a risk-based framework implemented by the Department of Health to regulate the supply of medical devices. A key feature of the MDACS is the Listing System, which requires manufacturers and importers of medical devices, except for Class I devices, to voluntarily list their products to demonstrate compliance with safety and performance standards. To ensure the efficiency of the listing process, the Medical Device Division (MDD) has recently updated the time arrangement for processing renewal applications for listed medical devices in the GN-01 “Overview of the Medical Device Administrative Control System” (2024-4(E) Edition) guidance notes. This article outlines these changes and offers recommendations for medical device Local Responsible Persons to ensure seamless compliance.

 

Understanding the Role of the LRP
Central to the MDACS is the concept of the Local Responsible Person (LRP). The LRP acts as a crucial intermediary between manufacturers, importers, the government, and users in Hong Kong. Any manufacturer wishing to list a device under the MDACS must designate an LRP, particularly if they do not have a registered place of business in Hong Kong.
The LRP bears several responsibilities, including managing applications for listing, maintaining communication channels with users, importers, distributors, the public, and the government, maintaining records of device supply, complaint handling, managing traceability, reporting changes, adverse events, recalls and safety notices.

 

The Updated Time Arrangement
A device’s listing approval is valid for five years. The previous GN-01 (2024-3(E)) only stated that the LRP must submit a renewal application of the listing to the MDD at least 12 weeks before the listing expiry date. However, starting from 1 January 2025, the updated GN-01 (2024-4(E))) will be implemented, providing a specific timeline:

• LRPs shall submit renewal of the listing to the MDD at least 12 weeks to 1 year (both the first and last days counted) before the listing expiry date.
• Unless the application reaches MDD within the above time frame, the listing renewal application will not be processed.

 

Adapting to the New Arrangement
The new time arrangement has significant implications for LRPs operating in Hong Kong.

 

Consequences of Late Submissions
Manufacturers and LRPs must be aware that renewal applications that fails to reach MDD before the 12-week mark from the listing expiry date will not be processed, leading to the expiration of the listing. If a listing expires, LRPs must submit a new application, adhering to all requirements for new listings all over again.

 

Recommendations

To adapt to the new time arrangement and avoid any disruption to their product listings, manufacturers and LRPs should:

• Proactive Planning:
  - Establish a system for tracking listing expiry dates and initiating the renewal process well in advance.
• Understanding Requirements:
  - Thoroughly review the updated GN-01 (2024-4(E) Edition) and other relevant guidance documents to understand the renewal process fully.
  - Stay updated on any further announcements or changes from the MDD.
• Seeking Expert Advice:
  - Consider engaging regulatory consultants like Qualtech Consulting Corporation for guidance and support throughout the renewal process.

 

Keep Updated!
The MDD's updated time arrangement for processing renewal applications of listed medical devices compels Medical device manufacturers and LRPs to adapt their practices accordingly and avoid any disruption to the listing of their devices. By understanding the new requirements, planning proactively, and engaging with experts like Qualtech Consulting Corporation, manufacturers can ensure continued compliance and access to the Hong Kong market.
 

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives. 
Connect with us today here to unlock your medical device potential.

 

 

References:

• MDD Announcement: New arrangement of Processing of Renewal Application of Listed Medical Device
• Overview of the Medical Device Administrative Control System Guidance Notes: GN-01