Health committee  There are different forms—

Health committee  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

Health committee  Yes. There is a pre-market authorization by which a manufacturer would have to apply to Health Canada to obtain a licence to be able to sell this product in Canada. Part of the review of that will include some of the indications that the manufacturer is putting on the product, wh

Health committee  In terms of the countries that I'm aware of, or the regions of the globe that I'm aware of, the U.S. deemed these to be medical devices in 2005, and therefore the full aspect of their regulatory framework applied to them at that point in time. Mexico is close to bringing in requi

Health committee  I don't know the answer to that question.

Health committee  I will attempt to answer that question. As I mentioned, these have not been on the market without regulation, but I think we would all agree that bringing it into the medical devices framework will provide that pre-market assurance that products are safe and of sufficient quality

Health committee  Certainly. Thank you very much. There are two reasons for that amendment. The first reason is that this is the historical or traditional way of bringing this type of change into effect with a bill or a law. Second, what's being proposed here is that the coming into force of th

Health committee  Let me address the “cosmetic” issue first. “Cosmetic” is currently defined in the Food and Drugs Act, and we are supportive of a revised definition in order to remove any confusion about the products addressed in this bill. These are known as non-corrective or plano lenses, and w

Health committee  I'll be quite clear from the start. In my presentation, and from what we've heard today, the intention, as we understand the proposed bill, is that these will be class II medical devices. The current wording of the proposed amendment deems a non-corrective contact lens to be a

Health committee  Thank you, Madam Chair. I'm pleased to be here to discuss Bill C-313 and what it will mean to bring the regulation of non-corrective contact lenses under the authority of the Food and Drugs Act and the provisions of the medical devices regulations. The potential risks of these