By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued a draft notice on plans to implement a national Unique Device Identification (UDI) system based solely on guidelines developed by the International Medical Device Regulators Forum (IMDRF).
Health Canada states that it does not plan to add any additional UDI requirements specific to the Canadian market "at this time," relying completely on the IMDRF UDI Working Group’s finalized guidance issued in December 2013.
The regulator plans to issue further guidance on what the Canadian UDI system will look like within the next two years, according to the notice. Once a UDI is implemented, medical devices licensed for sale in Canada will need to comply; the current UDI implementation project in the US may provide a preview of how Health Canada will roll out and enforce UDI requirements for Medical Device License and Establishment License (MDL and MDEL) holders in the future.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.