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Medical Device Product Registration and Approval in Canada



Medical devices are regulated by Health Canada whose objective is to ensure Canada to be one of the healthiest people in the world. Medical devices are regulated under the Food and Drugs Act.




Medical devices are classified into 4 categories namely class I, II, III and IV (I being the lowest risk and IV being the highest risk).

•Class I device does not require a registration license; and


•Classs II, III, IV, the product registration requirements are as per written in the Canadian Medical Device Regulation (CMDR).


The CMDR is also mentioned in specific the Quality Management System (QMS) requirements for the manufacturer. Currently, the manufacturer is required to comply with the quality management system known as CAN/CSA ISO13485 from the recognized registrar under the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). This quality system will be replaced by MDSAP quality management system requirements by 1 Jan 2019.


ARQon can assist with product registration in Canada and setting-up of the quality management system so as to meet CAN/CSA ISO13485 or the MDSAP.


In terms of the Establishment License for the company, there are requirements for the Manufacturer, Importer and Distributor.


This Establishment concept has also been referenced to the development of Establishment Licensing requirements in Asia including Singapore. ARQon director has also helped in drafting of the Singapore regulation.

Example of Approval

Source:  Health Canada

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