Manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485 by a quality systems registrar accredited under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). For devices to be licensed by Health Canada, the requirement for certification of quality management systems is as follows:
- Class II manufacturers must be certified to at least ISO 13485 by a CMDCAS accredited certification body
- Class III and IV manufacturers must be certified to ISO 13485 by a CMDCAS accredited certification body
- Since 1 January 2003 all manufacturers of class II, III and IV devices are required to have been assessed by a CMDCAS accredited certification body
BSI is a recognized registrar under the CMDCAS program.
Full details of the CMDCAS program can be found on the Standards Council of Canada website.
