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CMDCAS Approval of MD
 
To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the Medical Devices Regulations.
Class I medical devices offered for sale in Canada do not require a medical device licence and are monitored through Establishment Licensing.
Class II, III, and IV medical devices offered for sale in Canada require a medical device license. To successfully apply for a medical device license the manufacturer must submit supporting documentation to demonstrate its safety and effectiveness.
Regulations also require that the manufacturers of class II, III and IV devices design and manufacture their products under a registered quality management system (QMS) that meets the criteria of the international standard ISO 13485: 2003. These manufacturers must have their QMS registered by a Registrar accredited to the CMDCAS scope.
For more information on the CMDCAS QMS requirements go to the CMDCAS QMS Requirements section.
 
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