About CMDCAS

The Canadian Medical Devices Conformity Assessment System (CMDCAS) was developed by Health Canada in collaboration with the Standards Council of Canada (SCC) to support the regulations of the Canadian Medical Devices Regulations. In summary, CMDCAS is the processes and requirements that qualify Registrars as being competent to perform audits of medical device manufacturers and issue registration certificates to satisfy the Canadian Medical Devices Regulations.

As part of the CMDCAS system, the SCC was designated as the organization to qualify accredited quality management systems Registrars to provide manufacturers’ certification to the appropriate standards. TÜV America Inc., Management Service division, was the first SCC qualified CMDCAS Registrar.

For a list of SCC qualified Registrars, click here.

ISO 13485:2003
In July 2003, Canada adopted the new ISO 13485:2003 standard that required all ISO 13485:1996 certificate holders to transition to ISO 13485:2003 by March 14, 2006.  Effective March 15, 2006 Health Canada 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. 

The change to the new ISO 13485:2003 standard requires a complete re-certification audit, which involves both an off-site document review and an on-site audit of all requirements.  All existing license holders must submit a copy of their new certificate to Health Canada by July 15, 2006.  

The CMDCAS program incorporates the requirements of the international standard:

ISO 13485:2003
Quality systems - Medical devices –Quality Management Systems - Requirements for regulatory purposes

This standard has been adopted by the Canadian Standards Association (CSA) and have been approved as a National Standards of Canada by the Standards Council of Canada, under the following reference number:

CAN/CSA-ISO 13485-2003
Medical devices – Quality Management Systems - Requirements for regulatory purposes

For more information, contact us.