Canadian regulations require that medical devices be manufactured under a certified quality management system that meets the criteria of the international standard, ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes. The corresponding national standard is CAN/CSA-ISO 13485.
Health Canada’s Therapeutic Products Directorate, in collaboration with the Standards Council of Canada (SCC), developed the Canadian Medical Devices Conformity Assessment System (CMDCAS) to address this regulatory requirement.
Scope of accreditation
SCC accredits organizations that certify the management systems of medical device manufacturers. Under CMDCAS, only certification bodies accredited by SCC are eligible to certify medical device manufacturers’ management systems.
Benefits of SCC accreditation
SCC accreditation demonstrates an organization’s competence to manage and perform activities defined by its specific program scope of accreditation. Through SCC accreditation, certification bodies are able to obtain independent, third-party, credible test results for themselves and for their customers.
SCC accreditation helps certification bodies deliver services with confidence and attract new customers. As a signatory member to several international mutual recognition and multilateral agreements, SCC’s Accreditation Program is internationally recognized.
SCC’s Criteria and Procedures section highlights each international standard and Canadian procedural document whose requirements must be met for a particular accreditation program.
For more information
For more information, please contact SCC Accreditation Services at firstname.lastname@example.org.