What makes something a medical device?
February 15, 2011 1:03 PM Subscribe
What are the regulations around being a medical device or not for product sales in Canada and the US?
I'm looking at buying the assets of a non-profit that was manufacturing and marketing a product. However, I'm unsure whether there are regulations about this type of product.
It's an exercise aid, but perhaps it is also a medical device, since you would derive health benefits from doing exercises. And, even if it doesn't qualify as a medical device, are there regulations around selling exercise aids?
I can't figure out what makes something a medical device or whether you can sell a product and have it just be an exercise aid (or whether that too is licensed/regulated). When I review government literature here in Canada, I can see how medical devices are classified, but I can't tell if there's a line you can stay on one side of and not be a medical device.
I also cannot figure out the process for licensing a product as a medical device. I've been to the Health Canada website, but it's not set up to help someone start and run a medical device company.
US answers also welcome, as I would want to market this product in the US too via Internet sales.
I've got calls/emails into half a dozen places, but I have not heard back yet. I have a strong background in business and new venture development, so I am a bit stunned that this information is so hard to find.
Anonymous because I already run a business and do not want to spook any of my existing clients, who might be concerned about the future of my existing business.
Thanks.
I'm looking at buying the assets of a non-profit that was manufacturing and marketing a product. However, I'm unsure whether there are regulations about this type of product.
It's an exercise aid, but perhaps it is also a medical device, since you would derive health benefits from doing exercises. And, even if it doesn't qualify as a medical device, are there regulations around selling exercise aids?
I can't figure out what makes something a medical device or whether you can sell a product and have it just be an exercise aid (or whether that too is licensed/regulated). When I review government literature here in Canada, I can see how medical devices are classified, but I can't tell if there's a line you can stay on one side of and not be a medical device.
I also cannot figure out the process for licensing a product as a medical device. I've been to the Health Canada website, but it's not set up to help someone start and run a medical device company.
US answers also welcome, as I would want to market this product in the US too via Internet sales.
I've got calls/emails into half a dozen places, but I have not heard back yet. I have a strong background in business and new venture development, so I am a bit stunned that this information is so hard to find.
Anonymous because I already run a business and do not want to spook any of my existing clients, who might be concerned about the future of my existing business.
Thanks.
Overview of US medical devices definition and approval process here.
Two industry groups to look into (a friendly email might identify if anyone had ever heard of FDA or the Canadian equivalent attempting to regulate devices that fall under the category you're talking about - and if not, they can at least point you to a consultant who can advise you): Medical Device Manufacturers Association & AdvaMed.
I would imagine that the US answer goes something like "yes, technically lots of exercise equipment, consumer heart rate monitors, and other products sold on late-night infomercials are technically class I devices, but the fact of the matter is that most don't ever register and list with FDA, and there's very little real enforcement going on in this area." But take that with a shaker of salt; I haven't looked into it. All I know is that my FitBit claims it isn't a medical device, and they haven't received a warning letter yet.
Oh, and you can also check all registered/listed FDA devices using this search tool. More complex devices are under the 510(k) or PMA search tools.
posted by deludingmyself at 1:55 PM on February 15, 2011
Two industry groups to look into (a friendly email might identify if anyone had ever heard of FDA or the Canadian equivalent attempting to regulate devices that fall under the category you're talking about - and if not, they can at least point you to a consultant who can advise you): Medical Device Manufacturers Association & AdvaMed.
I would imagine that the US answer goes something like "yes, technically lots of exercise equipment, consumer heart rate monitors, and other products sold on late-night infomercials are technically class I devices, but the fact of the matter is that most don't ever register and list with FDA, and there's very little real enforcement going on in this area." But take that with a shaker of salt; I haven't looked into it. All I know is that my FitBit claims it isn't a medical device, and they haven't received a warning letter yet.
Oh, and you can also check all registered/listed FDA devices using this search tool. More complex devices are under the 510(k) or PMA search tools.
posted by deludingmyself at 1:55 PM on February 15, 2011
There are several classes of medical devices overseen by the FDA. Generally speaking: implants, devices and supplies used in medical procedures or diagnostic and other monitoring equipment. Each class will have specific regulations defined under the CFR in the US. You can look this up on the FDA's website.
IANAL, but I doubt an exercise device would be classed a medical device unless its design was specific to use in a particular procedure.
posted by michswiss at 2:10 PM on February 15, 2011
IANAL, but I doubt an exercise device would be classed a medical device unless its design was specific to use in a particular procedure.
posted by michswiss at 2:10 PM on February 15, 2011
This thread is closed to new comments.
On the side of less hourly billing, is one of the places you've tried researching this your closest Canada Business Centre Library?
posted by RobotHero at 1:35 PM on February 15, 2011