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HEALTH CANADA & MEDICAL DEVICE CLASS

HEALTH CLAIMS MAY CAUSE CHANGE IN MEDICAL DEVICE CLASSIFICATION!

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Canada has a robust system or regulations 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 Direct Selling 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 are 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) and how active (vs. passive) the Medical 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, recently Health Canada appears to be classifying what would otherwise be Class I Medical Devices as Class II based simply on their product "claims" – i.e., what the Medical Device might be capable of doing rather than how non-invasive or passive the Medical Device might be.

It is presently unclear whether Health Canada has a right to make these reclassifications, as this approach does not seem to be 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.

For help with Medical Device Issues, please click here.