On a note sent to interested stakeholders, Health Canada announced that, over the next two years, guidance documents for manufacturers on the implementation of a Unique Device Identification (UDI) system for Medical Devices sold or imported in Canada will be developed.
In order to minimize the regulatory burden on businesses, Health Canada will rely on the principles outlined in the guidance document issued in December 2013 by the International Medical Device Regulators Forum (IMDRF) UDI working group; no additional UDI requirements specific to the Canadian market will be added at this time.
