Singapore: New Revision of the Medical Devices Product Classification Guide

On 24^th January 2024, the Health Sciences Authority (HSA) of Singapore issued Revision 10 of the “GN-15 Guidance on Medical Device Product Registration”. The highlighted key update, especially for the evaluation routes of Immediate Class B Registration (IBR condition 1) and Expedited Class C Registration (ECR-1), is as follows:

• Removal of marketing history in Singapore as one of the qualification criteria.
• The medical devices that will undergo the above-mentioned evaluation routes should have been marketed for at least 3 (three) years in the independent reference regulatory agency’s jurisdiction, such as Health Canada (HC), Japan Ministry of Health, Labour and Welfare (MHLW), United States Food and Drug Administration (US FDA), Australia Therapeutic Goods Administration (TGA)/European Union Notified Bodies (EU NB), and the corresponding approvals listed. 

These updates were made to align with the current requirements.

Further information on Revision 10 of the GN-15 Guidance on Medical Device Product Registration can be accessed here.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.