Software in Medical Devices, by MD101 Consulting

Canadian regulations

Canadian regulations about medical devices can be found on justice canada website. There are four classes (see section 6 and 7 of the regulations), like in CE mark. Class I devices are auto-certified by the manufacturer, like CE mark. The rules published to classify medical devices are located in Schedule 1 of the regulations, like Annex IX of CE directive.

Software classification

Classification of software medical devices is pretty similar to CE rules. Software are active medical devices and there are 5 rules about active medical devices: rules 8 to 12. Their content is almost the same as CE rules. For example rule 12 is the fall-through rule for all other devices in class I. So, if you know the classification of your device according to CE mark, you should gess it quickly for devices in Canada.

Exceptions

Alas! There are always exceptions. Health Canada edited last year a Notice on Software Regulated as a Class I or Class II Medical Device. You think your software is class I, you read this notice and, tadaa ... it is class II. If you find that the CE rules are cumbersome, I bet you think the same about canadian rules! :-/

Same design documents

But let's have a look at the good side of the medal. The documentation requirements are almost the same. Manufacturers of class II medical devices have to comply with ISO 13485, except design procedures. And manufacturers of class III medical devices have to comply with ISO 13485 entirely. As design is the most important step to mitigate risks in software, you have to document your design.

So, if you have a technical file for the CE mark, which documents your software design, you can reuse 90% of it for the Canadian licence (the remaining 10% are specific to Canadian regulations, like labelling). Canada, nous voilà!