Canada Market Access
Understanding the Canadian medical device regulations and CMDCAS
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.
The application process for a Class II, III or IV Medical Device License requires manufacturers to demonstrate that their products are safe and effective, and that they meet applicable standards. To verify compliance with the quality system requirements, companies applying for a Medical Device License must submit evidence of certification to the requirements of ISO 13485.
Importantly, Canadian authorities will accept only ISO 13485 certifications issued by a certification body that has been accredited by the Standards Council of Canada (SCC) and which has been recognised by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). ISO 13485 certifications issued by entities not accredited by the SCC and not recognised under the CMDCAS cannot be used in support of Medical Device License applications.
TÜV SÜD is the first certification body accredited by the SCC to certify quality management systems (QMS) for medical devices according to the requirements of ISO 13485. TÜV SÜD client companies who have certified their QMS to ISO 13485 may be able to eliminate duplicative quality system evaluations and use their certification in other markets. TÜV SÜD can also evaluate and certify the electrical safety of medical devices in compliance with CSA C22.2 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, including electromagnetic compatibility (EMC).
The application process for a Class II, III or IV Medical Device License requires manufacturers to demonstrate that their products are safe and effective, and that they meet applicable standards. To verify compliance with the quality system requirements, companies applying for a Medical Device License must submit evidence of certification to the requirements of ISO 13485.
Importantly, Canadian authorities will accept only ISO 13485 certifications issued by a certification body that has been accredited by the Standards Council of Canada (SCC) and which has been recognised by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). ISO 13485 certifications issued by entities not accredited by the SCC and not recognised under the CMDCAS cannot be used in support of Medical Device License applications.
TÜV SÜD is the first certification body accredited by the SCC to certify quality management systems (QMS) for medical devices according to the requirements of ISO 13485. TÜV SÜD client companies who have certified their QMS to ISO 13485 may be able to eliminate duplicative quality system evaluations and use their certification in other markets. TÜV SÜD can also evaluate and certify the electrical safety of medical devices in compliance with CSA C22.2 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, including electromagnetic compatibility (EMC).
Your benefits at a glance
- SCC accredited - TÜV SÜD has been accredited by the SCC to evaluate and certify quality management systems according to the requirements of ISO 13485.
- Quality system certification and auditing expertise - TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.