Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.