Jun 27, 2014
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.
The International Medical Device Regulators Forum (IMDRF), formerly known as the Global Harmonization Task Force or GHTF, has published long-awaited draft recommendations for Unique Device Identification (UDI) systems (PDF) for medical devices.
The US Food and Drug Administration has published new training material to help medical device manufacturers comply with new Unique Device Identification (UDI) requirements in the country.
The FDA UDI system requires US medical device market registrants to set up and maintain accounts with a Global Unique Device Identification Database (GUDID). Once registrants have opened accounts, they can submit device identification information into the database according to FDA rules. UDI data entered into GUDID is publicly searchable.