The document “Guidance Notes for Changes of Listed Medical Devices” (GN-10) has been issued. GN-10 will be effective from 1 January 2024. The document aims to assist the Local Responsible Persons in categorising, managing and reporting changes of listed medical devices. Please click here to view the document.
Starting from 1 January 2024, the Local Responsible Persons shall comply with the new requirements, and submit the Change Applications with the revised Change Application Form. The revised Change Application Form will be available on that day.