Health Canada

Health Canada’s mission is to promote healthy lifestyles, prevent chronic diseases, and protect Canadians from health risks. This is achieved through the evaluation, regulation, and monitoring of the safety, effectiveness, and quality of health products in Canada.

For medical devices and IVDs in risk classes II to IV, approval in Canada is granted through a so-called “Medical Device Licence Application.” The risk class largely determines the content and scope of the licence application. It is also worth noting that approval in Canada is only possible if you hold an MDSAP (Medical Device Single Audit Program) certificate.

Together, we address:

• Which Canadian risk class applies to your product?
• What content is required in the Medical Device Licence Application for your product?
• How can we respond to questions from the Health Canada review concerning the submission?
• Gap analysis between ISO 13485:2016 and MDSAP – where do existing processes need to be expanded and new processes established?