Health Canada is the agency that regulates medical devices in Canada. They require manufacturers of Class II, III and IV medical devices to meet the quality system requirements of ISO 13485:2003. Companies selling these devices that are not ISO 13485:2003 certified by a Health Canada CMDCAS accredited Registrar will not be allowed to market their devices in Canada.
Health Canada certification for devices
For obtaining Health Canada certification, a medical device manufacturer must go through several steps to sell their devices in Canada:
- Class II, III and IV device manufacturers are required to complete and submit a Medical Device Licence (MDL) application.
- Class II, III and IV manufacturers must be certified to ISO 13485 by a certification body registrar by CMDCAS
- Class II and III device licences are similar to a US FDA 510(k) application
- The Class IV device licence is typically more complicated than a standard US FDA 510(k) submission, but less complicated than a US FDA Premarket Approval (PMA) application.
This is a simplified version of the certification process in Canada. To see a more detail overview of the steps, please download our chart explaining the Canadian medical device approval process
How we can assist with CMDR compliance and Health Canada certification
Emergo specializes in helping medical device and IVD companies meet the Canadian Medical Devices Regulations (CMDR) so they can gain access to this sizable market. We can help you implement complete your Medical Device Licence application so that you are in full compliance with the Canadian Medical Devices Regulations (CMDR).
Emergo has helped hundreds of medical device manufacturers with the Health Canada certification and CMDR consulting services for medical device companies.