How does a company that wants to sell a medical device in Canada
get started? Eileen McMahon, Yolande Dufresne, Yu Seon Gadsden-Chung and Grant Worden dive into the top questions on
the rules and regulations that govern the space, including:
- Can unapproved medical devices be sold in Canada?
- How can you get marketing authorization to sell a medical
- 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
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
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
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
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
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
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