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Hello, Further to the information already provided please note that the term "sell" in the Canadian Food and Drugs Act includes "giving" and "loaning" (so no money needs to transfer hands".  It is defined as follows: sell includes (a) offer for sale, expose for sale or have in possession for sale ...

Hi Linda, You are correct that the requirements for what is submitted to Health Canada for a Risk Class II medical device is very basic. This is based on the fact that a risk Class II device is considered a low risk device and that Health Canada accepts the manufacturer's attestation in the application ...

Hi Nomi, From my experience, if the test reports include enough detail, then the protocols are not required to be submitted. A good summary can also include any relevant missing information that may have been left out of the report so that questions are avoided from HC. That said, sometimes it is ...

Hello Anon, As the regulations came into effect on December 23, 2021, it was required that manufacturers of Class III and IV medical devices submit their first summary report before December 23, 2022 (and December 23, 2024 for Class II medical devices). Whatever date was chosen would then be the anniversary ...

Hi Joseph, Yes, that would be correct. Remember also that If changing/updating the algorithm impacts the intended use at all, then you would also have to update that at the same time as adding the new version to the licence in the amendment. This of course would have to be done by a "full" amendment ...