Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect from 7 March 2023.
HSA’s Medical Device guidance GN-21: Guidance on Change Notification for Registered Medical Devices was also updated accordingly.
The enhancements include the following:
• GN-21 Annex 3 Safety and Performance Declaration (which was previously required as a separate document) will now be incorporated into the online MEDICS platform to allow ease of declaration by Registrant. This document will no longer be required as part of GN-21 Change Notification submission.
• The change categories reflected in HSA’s MEDICS system will also be fully aligned with HSA’s Change Notification guidance document GN-21.
To view the updated GN-21, please visit the following link: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-21-r5-guidance-on-change-notification-for-registered-md-(2023-mar)-pub.pdf