CMDCAS Canadian Medical Devices Conformity Assessment System

Important notice for all Canadian and foreign manufacturers of Medical Devices. Click here for more information.

The emphasis on continuous improvement and the pressures of global competition suggest that management systems registration will continue to be regarded as a major ingredient for success for years to come. QMI is well positioned to serve the growing numbers of companies who appreciate the strategic importance of registering their management system(s) with an internationally recognized auditing body.

CE Marking for Medical Devices

Companies who wish to access the European market will require the use of the CE designation and are urged to start the procedure right away and keep that competitive edge.

QMI will partner with DGM, a well-respected European Notified Body, regarding the classification and choice of route to obtaining the CE mark. www.dgm-nb.org

Since the publication of ISO 9001 and ISO 9002 in 1994, the ISO Technical Committee ISO/TC 210 developed two sector-specific standards:

  • ISO 13485 Quality Systems - Medical devices - Particular requirements for the application of ISO 9001.
  • ISO 13488, Quality Systems - Medical devices - Particular requirements for the application of ISO 9002.

The ISO 13485/13488 standards were developed specifically for the Medical Device Industry. They satisfy the Medical Device Licence Quality System Requirements of Health Canada. The standards are based on ISO 9001/9002 quality management and supplemental requirements for medical devices.

Registration to the standards listed below is mandatory for all Class II and above Medical Device Manufacturers* as per Health Canada as a condition for obtaining the device licence.

  • Class II manufacturers must register to ISO 13488:1996 but may choose to register to ISO 13485:1996.
  • Class III and IV manufacturers must register to ISO13485:1996.

Those requirements apply to:

  • manufacturers applying for a Health Canada (HC) medical device licence
  • manufacturers holding a valid HC medical device licence before January 1, 2003
  • manufacturers who have applied for a HC medical device licence before January 1, 2003 and to whom that licence is delivered after January 1, 2003, must comply starting on the date of issuance of that licence, but will have until November 1, 2003 to present their certificate to Health Canada.

New and renewed medical device licences required to sell Class II, III & IV medical devices in Canada will not be issued to manufacturers failing to comply with those mandates. The new quality system requirements do not apply to Class I medical devices.

*Note: Health Canada considers a distributor of medical devices a manufacturer if they distribute under their own name.

These are mandatory regulatory requirements (depending on the risk category) by Health Canada.

* Medical Devices Regulation Filesize: 100KB. Estimated download time: 13s @56.6Kbps