Guidance on Change Notification for Registered Medical Devices
The Health Sciences Authority Singapore has published updates to the guidance document titled ‘GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9’. This guidance document takes effect on 25 April 2022.
The main update in this revision is about ‘Change in Design and/or Specifications of General Medical Devices’ where the addition of a new connectivity feature to the registered device (e.g. Bluetooth, WIFI) is considered as a change that would require additional pre-clinical studies and/or clinical evidence. Such change falls under the Technical Category for Class C & D devices and the Notification Category for Class B devices.
Other minor updates reiterate the importance of providing supporting documents for HSA to review and permit the concurrent supply of old-label and new-label stock due to a change in product owner or a change in manufacturing and/or sterilisation site. If you have any questions regarding medical device registration and representation in Singapore, please contact us at sales@andamanmed.com