Regulatory Updates
Industry Briefing (Feb 2014)
Audiences
Healthcare professional
Industry member
Product type
Medical devices
1 August 2013
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[Updated on 1 April 2014]
Medical Device Branch (MDB) conducted 5 industry briefing sessions on 24, 25 and 26 February 2014 on the updates to the Change Notification for registered devices as part of the on-going enhancements to the medical device regulatory framework.
Revised guidance and presentation materials can be downloaded from the links below:
GN-21-R3 Guidance on Change Notification for Registered Medical Devices [pdf]
GN-21 Annex 1 Change Notification Checklist [doc]
GN-21 Annex 2 Summary Table of Change Notification [doc]
GN-21 Annex 3 Medical Device Safety and Performance Declaration Template [doc]
GN-24-R1 Guidance on the Change of Registrant [pdf]
GN-24 Annex 1 Change of Registrant Application Form [doc]
GN-24 Annex 2 Relinquishing Company Declaration Form [doc]
Industry Briefing Slides – Overview of Regulatory Updates [PDF, 319 KB]
Industry Briefing Slides – Updates on MEDICS – Change Notification Platform [PDF, 1063 KB]
GN-21-R3 Guidance on Change Notification for Registered Medical Devices [pdf]
[Updated on 01 August 2013] HSA & Singapore Medical Association (SMA) meeting
Sharing of HSA's MD regulations enhancements to Singapore Medical Association (SMA) [PDF, 560 KB]