May 7, 2015
Health Canada, the Canadian medical device market regulator, has announced changes to the Therapeutic Products Directorate’s List of Recognized Standards applicable to medical devices.
The regulator’s proposed changes include adding 26 new standards, nine new editions of current recognized standards, and removing 17 standards.
Comments on Health Canada’s proposed changes are being accepted through July 6, 2015.
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.
Canadian regulators have updated their list of recognized standards pertaining to medical devices, affecting manufacturers applying to Health Canada for Medical Device Licenses (MDL).
Changes to the list include 15 new standards, 11 new editions of current standards and removal of 14 standards.