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.