How can you get marketing authorization to sell a medical device?
What are other regulatory requirements to keep in mind?
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Grant Worden (00:06): Hello and welcome to the next installment in Torys' 8-part medical device series, "So you’re coming to Canada, eh? An overview of Canada's laws affecting the medical device industry." My name is Grant Worden. I'm a Partner in Torys' Litigation Department and lead the Product Liability Practice at the firm. I'm joined today by Eileen McMahon,
Eileen McMahon (00:23): Hello.
Grant Worden (00:24): Yolande Dufresne,
Yolande Dufresne (00:25): Hello.
Grant Worden (00:25): And Yu Seon Gadsden-Chung.
Yu Seon Gadsden-Chung (00:27): Hello.
Grant Worden (00:27): And we'll be continuing our discussion of medical device regulation in Canada. Eileen, let me start with you. In another installment of our medical device series, we learned that most medical devices, other than those in the lowest risk class, require premarket approval from Health Canada before they can be sold in Canada. Does this mean that certain medical devices can be sold in Canada without obtaining Health Canada approval?
Eileen McMahon (00:54): That's correct, Grant. The law has evolved. So some decades ago in Canada, you could actually sell all medical devices without approval, subject to approximately 5% that required pre-approval. But today's law is such that we have four risk classes of medical devices, from Class I being the lowest perceived risk class, to Class IV being the highest perceived risk class.
Yolande Dufresne (01:23): And so Class I, for example, does not require pre-approval before a manufacturer or distributor seeks to market the medical device in Canada. So Class I devices, for example, would be thermometers, low-risk devices like barriers, wound dressings, for example. And in contrast, Class IV devices would be high-risk implantables, such as cardiac pacemakers. So that gives you a sense of the different risk classes between the devices.
Grant Worden (01:59): Yolande, what type of information is required to be submitted in a Medical Device Licence Application?
Yolande Dufresne (02:05): So the information that needs to be submitted does vary based on the class type of the device or the class number. So the lower risk Class II device licence applications have less onerous informational requirements than the higher risk Class III and Class IV device licence applications. So really, across the board, you're going to need to submit some basic information like the name of the device, the proposed labeling for the device, as well as the instructions of use. And one item that needs to be submitted also is the MDSAP Quality Management Certificate. And we find that this is a step that can often cause delays if a company hasn't properly prepared to obtain their MDSAP certificate in advance.
Eileen McMahon (02:46): That's a very good point, Yolande, yes.
Yolande Dufresne (02:47): Because it does take a number of months to obtain it, and Health Canada actually won't review the licence application until that's been submitted. So just to keep that in mind. And then Class III, Class IV devices, you do need to submit safety and efficacy data, which takes time to prepare, as well as information about the distribution or licensing of the device in other countries.
Grant Worden (03:14): And I'm just picking up on that. Yu Seon, for manufacturers who have obtained market authorization for medical devices in other countries, can they leverage their pre-existing information in their Canadian Medical Device Licence Application?
Yu Seon Gadsden-Chung (03:27): Yes, thank you. Depending on the risk classification of the medical device in the other jurisdictions, certain of the information that were submitted to the other regulators such as the US FDA can be leveraged to prepare the Canadian Medical Device Licence Application. And of course, just a point to remember is that there may be additional requirements under the Canadian medical device regulations and other applicable guidance that may not have been submitted to the other regulators.
Grant Worden (03:54): And Yolande, is information that's submitted to Health Canada as part of a Medical Device Licence Application treated confidentially by Health Canada?
Yolande Dufresne (04:01): It's a good question. I'd say the starting position is that the information is treated as confidential, but there are, of course, a number of exceptions that would allow for the information to be disclosed. And so you always want to be cautious about that. Some examples would be in Canada, we have an Access to Information law similar to the US FOIA legislation. So this allows any member of the public to request information held by government bodies like Health Canada. So it's possible that a third party could requested information in the licence application. The applicant would have the ability to try to oppose the disclosure, but often there is still a substantial amount of information that does get disclosed or in redacted form. Another way that information can be disclosed is that Health Canada also has the ability to publish clinical information in Class III and Class IV device licence applications, and they've started a practice with publishing this information on the Health Canada website. So companies should also be aware of that exception. I would say a best practice is to always mark everything that you submit to Health Canada as confidential and if you have someone within your organization that manages information disclosure requests, it's a good practice to include their contact information as well, so that Health Canada knows who to reach out to.
Yu Seon Gadsden-Chung (05:17): And just to add a point here, Grant, although Health Canada has the right to disclose clinical information contained in Class III and Class IV, Medical Device Licence Application, disclosure does not include, for example, clinical information that was not used by the manufacturer in the submissions to support the proposed conditions of use, or clinical information that describes tests, assays or specific methods that are exclusively used by the manufacturer. So examples of this information could be trade secrets or confidential information.
Grant Worden (05:53): Eileen, other than obtaining a medical device licence for Class II to IV medical devices, are there any other regulatory requirements to sell medical devices in Canada?
Eileen McMahon (06:04): Well, one thing to keep in mind is the Medical Device Establishment Licence, which is also required under the Medical Device Regulations and Food and Drugs legislation. So what does that mean? An "MDEL", is the acronym, is required for a person to import and distribute the medical device in Canada. So that's definitely something to keep in mind and work that into your timeline. But in addition, Grant, companies coming to Canada will often first reach out to Yu Seon, Yolande and I, regarding the regulatory dossier. But there are many other considerations if a company is going to launch in Canada, for example, corporate structure, tax issues, hiring country managers, how they plan on distributing, through a distributor or directly, import-export requirements. So these are some other issues that we are happy to advise on with other team members, but I haven't addressed them in detail today just for the sake of sticking to medical device regulation.
Grant Worden (07:12): Well that's terrific. Thank you very much, Eileen. Thank you, Yolande. Thank you, Yu Seon. Thank you all for being here today. And thank you for joining us. We hope you'll join us for our next installment in our 8-part medical device series, "So you're coming to Canada, eh? An overview of Canada's laws affecting the medical device industry."
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