Canadian Regulatory requirements
The market for medical devices in Canada has experienced rapid growth, making Canada a prime market for medical device manufacturers. This is especially so since imported medical devices account for a large percentage of all medical devices sold in Canada.
Manufacturers of medical devices in classes II, III or IV wishing to apply for a Medical Device Licence must demonstrate that their products are in compliance with the requirements of the Canadian Medical Devices Regulation (CMDR SOR/98-282). For this purpose they need to submit the Technical Documentation of their devices, including the relevant evidence regarding safety and efficacy, to Health Canada, the authority responsible for the licensing of medical devices. The Technical Documentation covers evidence of compliance with international standards, risk management and, where applicable, clinical data. In addition, the manufacturer requires a quality management system certified according to ISO 13485.
So far, Health Canada has accepted ISO 13485 certificates issued by certification bodies accredited by the Standards Council of Canada (SCC) (the national accreditation organisation of Canada) and recognised by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS).
How can we help you?
With effect from 1 January 2019, application for, or maintenance of, a Medical Device Licence with an ISO 13485 certificate issued according to Canada's Medical Devices Conformity Assessment System (CMDCAS) will no longer be possible. The system will be replaced by the Medical Device Single Audit Program (MDSAP). Given this, manufacturers of medical devices in classes II, III and IV wishing to continue placing their products on the Canadian market need to participate in the MDSAP. TÜV SÜD is recognised as an auditing organisation under the MDSAP program and is thus authorised to carry out audits and issue a certificate if the audit was successful. By issuing this certificate, we confirm that the manufacturer's quality management system is in conformity with ISO 13485.
Please also observe the following notice from Health Canada regarding adjustments to MDSAP transition here.
TÜV SÜD is also authorised to test and certify the electrical safety of medical devices according to the Canadian Standard CSA C 22.2 No. 60601-1 Medical Electrical Equipment.
- ISO 13485 certification – TÜV SÜD has been accredited by the SCC to evaluate and certify quality management systems according to the requirements of ISO 13485.
- Product safety testing – TÜV SÜD Product Service is accredited by the SCC to test and certify medical devices to the product safety requirements of CSA C22.2 No. 60601-1 Medical Electrical Equipment.
- Other testing and certification services – In addition to testing and certifying medical devices for Canada, TÜV SÜD Product Service can also provide compliance testing for medical devices for other relevant regulations and standards.