So, Health Canada governs all of Canada's medical device, drugs, biologics and public health, much like USA's FDA. Their regulatory laws and structure are generally modeled after EU's system. Class I-IV, Class I being the lowest risk and Class IV being the highest.
Now, it would be easy to imagine, medical marijuana laws coming under the medical device acts in Canada and something in the supply chain (i.e. the manufacturing process) needing to be registered within the medical device regulatory paradigm. This helps ensure a good manufacturing process is in place, and if there are problems they are behold to medical device recall laws. I wouldn't think Marijuana manufacturing would fall under the highest risk which is reserved for drugs, implants, etc that are directly put in to a patient. With Marijuana, it still gets tested before released, and there is enough evidence to show it's generally safety.
So for Class I, they would be required to get a 'Health Canada Medical Device License (MDL) and MDEL Registration' Is the scheme of regulatory this is on the lower end of complexity, but still requires the ISO 13485 system in place (plus the additional specifics that Canadian Medical Device Requirement have -known in the regulatory world as CMDR) Still is not a small thing, and so in general need to be serious about your plans.
I'm not completely familiar with Marijuana and Canada's laws, I suppose I should brush up. But it would be the easiest paradigm to imagine, or some derivation of it.
Here is a general reference about what a MDL / MDEL entails:
I would not imagine this goes to the Class II-III-IV level as the risk simply is not there, but again I don't know. And even it is was, that only means they worked even harder to pass the regulatory and the big deal is even bigger.
So, until I see what it's about it can only be speculation, so all of this is a guess. Regardless, I would imagine it will allow them to market there product in Canada for growing Marijuana. Yes they could do the same in other non medical industries with lesser regulations, but it would be a solid testament to their manufacturing process and a barrier for other entrants.
At the end of the day, it was a significant bomb tossed out casually. :)
If anyone is wondering why my ears perked up. I've worked in Silicon Valley start ups in Quality and Regulatory in Biotech, Medical Device, Clinical Diagnostics, and IVDs for the past 20+ years. (Currently in Clinical Genomics)
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