The Medical Device Division (MDD) of the Hong Kong Department of Health has announced revisions to the Guidance Notes for Changes of Listed Medical Devices (GN-10) under the Medical Device Administrative Control System (MDACS).
GN-10 is a document that sets out points for consideration by the Local Responsible Person (LRP) when a listed device is in the process of change.
Read the full update here:
Department of Health | Medical Device Division – MDACS Activities – The Guidance Notes for Changes of Listed Medical Devices [GN-10] has been updated
Purpose of the Update
To announce revisions to the Guidance Notes for Changes of Listed Medical Devices (GN-10).
To clarify reporting requirements, application outcomes, and submission procedures for changes to listed medical devices under MDACS.
Scope of Application
This revision applies to manufacturers, Local Responsible Persons (LRPs), and applicants preparing medical device documentation, labeling, and regulatory submissions under MDACS.
Key Updates
Revised Clause 5.1.3
Clarified that the transfer of LRP is regarded as a Major Change and the party taking over shall submit the Takeover Application.
Added Clause 5.3
Defined changes that do not require reporting to the MDD.
Updated Flowcharts and Appendix 1
Updated Flowcharts A, B, C, E, and G to reflect non-reportable change conditions, with examples provided in Appendix 1.
Amended Clause 7.6.1: Application Results
Application outcomes may be rejected, approved, or conditionally approved. Any special conditions will be specified.
If rejected, the LRP shall not proceed with the change.
Other Updates
MDIS Platform
All Change and Withdrawal applications shall be submitted via the MDIS Platform.
Clause 9
New addition requiring compliance with the Prevention of Bribery Ordinance.
Clause 7.7
Deletion of the clause regarding replacement of the Listing Certificate during Change applications due to e-submission.
References
Read to learn more: [GN-10] Guidance Notes for Changes of Listed Medical Devices
Implications to Clients
These updates place greater responsibility on manufacturers and Local Responsible Persons to ensure compliance with revised reporting requirements and submission procedures.
Manufacturers and LRPs should review internal processes, strengthen compliance measures, and prepare for stricter oversight under MDACS.
Particular attention should be given to Major Change classification, non-reportable change conditions, MDIS submission requirements, and application outcomes before proceeding with any change to a listed medical device.
Effective Date
Immediate
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Hong Kong, please contact info@nordpacificmed.com.