Q: What is CMDCAS?

A: Canadian medical devices regulations that 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 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes.  The Canadian Medical Devices Conformity Assessment System (CMDCAS) was developed by Health Canada and the Standards Council to implement these new regulations.

As part of the system, the SCC accredits QMS certification bodies to register manufacturers' quality management systems to ISO 13485:2003.