I can speak, although this is not my particular area of expertise with respect to compliance and enforcement. I'm more on the pre-market side, but I think I can address the question.
There are certain penalties that are contained within the medical devices regulations themselves. For example, if, after we have authorized the product through a licensing mechanism, we find out that the product is not safe or is causing problems and some action needs to occur, we do have the authority under the regulations to cancel or revoke the licence for the product so that no further sales can take place. All mandatory problems that occur with these products need to be reported to Health Canada.
I'm assuming you're talking about the most extreme cases where we have somebody who is blatantly disregarding the law or the regulations. There are provisions in the Food and Drugs Act for fines to be administered. It's usually the last step in a compliance and enforcement action. We typically start with education and progress from there.