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As an International Trade Firm, a good part of our international trade practice is focused on product regulatory issues related to the importation, distribution and sale of regulated products in Canada. One highly regulated set of products is various Health Products regulated under the Canadian Food and Drugs Act (the “FDA”).
In this Product Regulatory Series Report, we review a recent Health Canada trend administratively recharacterizing Class I Medical Devices — the easiest Device to bring to market — as Class II Medical Devices, based simply (and perhaps unlawfully) on product claims!
What are Medical Devices?
In addition to governing “foods” and “drugs” the FDA regulates “devices” – commonly referred to as “Medical Devices”. "Devices" are technically defined in s. 2 of the FDA to mean "an instrument, apparatus, contrivance or other similar article … that is manufactured, sold or represented for use in (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals, or (b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals”.
This broad definition means that everything from crutches to pregnancy tests, and from back belts to dialysis machines is considered Medical Devices and subject to potentially stringent FDA requirements. The stringency of the rules varies by the "classification" that is attributed to the particular Medical Device, and as discussed below, Medical Devices can range from "Class I" (the least regulated) to "Class IV" (the most heavily regulated).
Medical Device Classification & Licensing
The classification and licensing of Medical Devices is dealt with primarily by the Medical Device Regulations , with the classification rules found in Schedule 1 (the “Classification Rules”). Broadly speaking, the Classification Rules characterize Medical Devices from Class I to Class IV based on how invasive (vs. non-invasive devices) and how active (vs. passive) the Device is. Class I Medical Devices, for example, are generally non-invasive and passive, and include manually adjustable hospital beds, hand splints, and mechanical wheelchairs. Class I Medical Devices are the ONLY class of Medical Devices that do not require Medical Device Licences (“MDLs”) from Health Canada, and can be generally brought to market quite quickly.
Medical Device Classification based on Product Claims?
Despite the quite clear Classification Rules, Health Canada appears to be recently classifying Class I Medical Devices based simply on their product "claims" – i.e., what the Device might be capable of doing rather than how non-invasive or passive the Device might be.
It is presently unclear whether Health Canada has a right to make these reclassifications, as these rules do not really appear in the text of the Classification Rules themselves.
How Does One Challenge a Health Canada Classification?
Medical Device classifications can be challenged, but usually only with the assistance of Experienced Product Regulatory Counsel. Getting things right on the classification front is usually key to a successful product launch in the Canadian marketplace.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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