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In our recent bulletins, we discussed branding considerations for prescription1 and over-the-counter drugs2 in Canada. In this bulletin, we turn to medical devices and examine how trademark law intersects with the regulatory landscape in this area.
Medical Devices in Canada
In Canada, a broad range of products fall under Health Canada's medical device regime. The Medical Devices Regulations ("MDR") define a medical device as a "device" within the meaning of the Food and Drugs Act3 ("FDA") that is intended for use in humans.4
Medical devices are grouped into four risk-based categories (Classes I-IV) under Health Canada's regulatory framework.5 Devices in Classes II, III, and IV require a Medical Device Licence ("MDL") from Health Canada before they may be sold in Canada.67
Regulatory Considerations: Device Name Oversight
In an application for an MDL, the name of the device (among other things) must be submitted to Health Canada.8 The MDR defines the "name of the device" as including "any information necessary for the user to identify the device and to distinguish it from similar devices."9 Although Health Canada has no publicly available standard for reviewing proposed device names, applicants should at minimum avoid names that could mislead consumers as to a device's intended use. Under s. 20(1) of the FDA, it is prohibited to label, sell, or advertise a device "in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its intended use."10
Once licensed, the device name and other required information must appear on the device label in accordance with the labelling requirements set out in sections 21 to 23 of the MDR. These requirements include bilingual labelling (English and French) for certain label elements, including the device name, when medical devices are sold to the general public.11 Applicants for MDLs will need to ensure that proposed device names are appropriate in both languages.
Trademark Considerations: Descriptive and Functional Names
Beyond regulatory considerations, trademark law imposes additional constraints on device naming if trademark registration is desired. Under the Trademarks Act, trademarks that consist of clearly descriptive or deceptively misdescriptive terms generally lack inherent distinctiveness (i.e., the quality that allows consumers to distinguish a company's goods or services from those of others) and, absent acquiring distinctiveness, are unregistrable as trademarks. 12
When a device name forms the subject matter of a trademark application and such device name contains purely descriptive elements, or combines both descriptive and distinctive elements, it may face objections during the examination of such application. Where the device name, when considered in its entirety, is not clearly descriptive, such objections can be overcome through arguments to the examiner. However, responding to objections increases costs and delays in registration. To address this challenge, some companies register only the distinctive portion of their device names as trademarks, rather than attempting to register the entire device name. For example, if a device name of a medical device licensed with Health Canada is "JUSTICE BLOOD GLUCOSE MONITOR", the applicant may seek trademark registration for "JUSTICE" alone. This approach may help avoid examination objections and create stronger trademark rights for the distinctive element, though trademark protection will be limited to the registered portion of the device name. Companies may still use the full device name on labels to satisfy regulatory requirements whilst securing trademark rights for its distinctive portion.
As discussed in our previous bulletins on brand names for prescription and OTC drugs, conducting a trademark clearance search is a crucial step in ensuring that a trademark is available for use and registration in Canada. The same principle applies to potential names for medical devices. In addition to comprehensive trademark searching, Health Canada's Medical Devices Active Licence Listing (MDALL)13 database may serve as a useful supplementary tool. The MDALL identifies medical devices that have been issued MDLs and their names. Some of these names may be used as trademarks for the applicable medical devices in the Canadian marketplace but are not subject to pending trademark applications or registrations. Accordingly, searching the MDALL can help identify potential conflicts with device names already in use in Canada that might not be discovered through searches of databases typically covered by trademark clearance searches.
Looking Beyond Canada
If a company intends on marketing a medical device outside Canada under the same name as the one that is used in association with the medical device in Canada, early consideration of trademark and regulatory requirements in other jurisdictions may be beneficial. Trademark laws and regulatory naming requirements can vary across jurisdictions, and what is permissible in Canada may differ from the requirements in other jurisdictions.
In markets where English or French is not the dominant language, translation and transliteration issues often arise. A name that works well in Canada may be confusing, difficult to pronounce, or carry unintended meanings in another linguistic or cultural context.
Early assessment of trademark availability and linguistic suitability in key target markets can help identify potential challenges before significant resources are invested in branding and regulatory submissions. For example, many companies with international commercialisation plans engage local trademark counsel in priority markets to navigate jurisdiction-specific considerations.
Summary and Conclusion
In summary, when choosing a name for a medical device, the following questions may be worth considering:
- Does the name suggest anything false or misleading, or is it likely to create an erroneous impression about the medical device and its intended use?
- Is the name appropriate in both English and French?
- Does the device name include any distinctive element or is it purely descriptive?
- Has a trademark clearance search been performed on the proposed name?
- For devices intended for international markets, have trademark availability, linguistic suitability, and regulatory naming requirements in key target jurisdictions been assessed?
As a national firm with strong global connections, our team of legal professionals provides integrated IP, regulatory and commercial advice to support clients with brand development and commercialization of medical devices in Canada and across borders. We can assist with trademark clearance searches, regulatory naming strategies and coordinated brand protection strategies across multiple jurisdictions.
Footnotes
1 Yue Fei, Aki Kamoshida, Pablo Tseng and Hugo Mak, "Naming Prescription Drugs: Navigating Regulatory and Trademark Challenges", McMillan LLP, (6 August 2025).
2 Yue Fei, Aki Kamoshida, Pablo Tseng and Oana Mirel, "OTC Brand Names: Balancing Consumer Appeal and Legal Risk", McMillan LLP, (29 September 2025).
3 Food and Drugs Act, RSC 1985, c F-27, s 2 defines a "device" as an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, 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, (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, (c) diagnosing pregnancy in human beings or animals, (d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or (e) preventing conception in human beings or animals; [...].
4 Medical Devices Regulations, SOR/98-28232, s 1. This bulletin does not discuss medical devices authorized for use or sale under Part 1.1 (medical devices for an urgent public health need), Part 2 (custom-made devices and medical devices to be imported or sold for special access), or Part 3 (medical devices for investigational testing involving human subjects) of the Medical Devices Regulations.
5 Medical Devices Regulations, SOR/98-28232, ss 6-7, Schedule I.
6 Medical Devices Regulations, SOR/98-28232, s 26.
7 Class I devices, which pose the lowest expected risk to human health and safety, do not require an MDL, though its manufacturers and importers must hold a medical device establishment licence (MDEL). See Medical Devices Regulations, SOR/98-28232, s. 44.
8 Medical Devices Regulations, SOR/98-28232, s 32(1)(a).
9 Medical Devices Regulations, SOR/98-28232, s 1.
10 Food and Drugs Act, RSC 1985, c F-27, s 20(1).
11 Medical Devices Regulations, SOR/98-28232, s 23(1).
12 Trademarks Act, RSC 1985, c T-13, s 12(1)(b); Molson Breweries v. John Labatt Ltd. (C.A.), 2000 CanLII 17105 (FCA), [2000] 3 FC 145, at para 86.
13 Health Canada, "About medical devices", (27 January 2020).
The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.
© McMillan LLP 2025
