Frequently Asked Questions
What are the QMS requirements for Class I devices in Canada?
There is no requirement for you to implement a full quality management system that is certified to ISO 13485:2003; however, you do have an obligation to implement a limited set of quality procedures related to product recall. However, if your medical device is classified as Class II, III or IV, you must demonstrate compliance with ISO 13485:2003 and the CMDR.
Can our existing Notified Body audit us for compliance with the CMDR?
Maybe. Most ISO Registrars are also European Notified Bodies, but not all Notified Bodies are Health Canada accredited Registrars. See if your Notified Body is on this Health Canada list.
Does the CMDR specify any Country of Origin requirements?
There is no requirement in the CMDR that a company must obtain approval in their own country (the country of origin) as a prerequisite to registration in Canada.