ISO Certification
Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.
Health Canada Quality Systems ISO 13485 and ISO 13488Health Canada Medical Device Licenses
What are ISO 13485 and ISO 13488?
ISO 13485 and ISO 13488 are standards that provide specific requirements for the application of ISO 9000 to the medical devices industry.
Because these two standards help to ensure the consistent application of quality requirements in this industry, they are being applied as part of the regulatory regime for medical devices in a number of countries. In Canada, for example, ISO 13485 and ISO 13488 form the basis for the new Canadian Medical Devices Conformity Assessment System (CMDCAS) (see What is CMDCAS? below).
What is CMDCAS?
New Canadian medical devices regulations, which took effect on January 1, 2003, require certain types of medical devices to be manufactured under a quality system that meets the requirements of ISO 13485 or ISO 13488 (see What are ISO 13485 and ISO 13488? above). The Canadian Medical Devices Conformity Assessment System (CMDCAS) has been developed by Health Canada and the Standards Council to implement these new regulations.
As part of the system, the Standards Council will qualify accredited QMS registration bodies to register manufacturers' quality management systems to the appropriate standards. For more information, please see the CMDCAS section of this site.