By Stewart Eisenhart, Emergo Group
Medical device market regulators in Canada have added 11 new items to their list of recognized standards, removed six and amended another 27.
Standards newly recognized by Health Canada include IEC and ISO standards covering various electrical medical device components, implantable devices and IVDs.
Standards deleted from Health Canada’s list include three IEC electromagnetic compatibility standards, two ASTM standards covering steel and metal device materials, and one ISO standard for ceramic implant materials.
Companies holding Medical Device Licenses or Medical Device Establishment Licenses for medical devices, or firms planning to apply for Canadian market authorization, should make sure their compliance with pertinent standards is up to date.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.