First published on May 7, 1998, the Canadian Medical Devices Regulations marked the first time a national regulatory body, Health Canada, has required a specific system standard as a prerequisite to medical device licensing.

The Canadian Medical Devices Regulations established a new licensing requirement for medical devices, which become effective January 1, 1998. (These requirements are found in sections 43 and 44 of the regulations) Originally scheduled to become effective July 1, 2001, the quality system requirements outlined in sections 32 (2) (f), 32 (3) (j) and 32 (4) (p) were amended and became effective January 1, 2003.

The quality system requirements of the Canadian Medical Devices Regulations outline that all manufacturers of applicable class II, III and IV medical devices sold in the Canadian market must receive and submit a valid ISO 13485 certificate issued by an SCC qualified CMDCAS Registrar. The ISO 13485 certificate is required to obtain a license to sell a medical device in the Canadian marketplace.

Effective March 15, 2006 Health Canada will no longer accepts new license applications unless an organization has an SCC-accredited ISO 13485:2003 certificate.  All ISO 13485/88:1996 certificates will become invalid after July 15, 2006. 

View the Medical Device Regulations: HTML

Quality System Requirements for Medical Devices: HTML | PDF