Canada Clarifies Oversight of Antimicrobial-Treated Class I Medical Devices

On December 5, 2025, Health Canada published SOR/2025-262 in Canada Gazette, Part II, amending the Pest Control Products Regulations to exempt Class I medical devices treated with antimicrobial preservatives from the application of the Pest Control Products Act (PCPA). This regulatory change resolves a long-standing overlap between Canada’s pesticide and medical device frameworks and aligns the treatment of Class I devices with that of Class II, III, and IV medical devices, which were already exempt. 

Before this amendment, Class I medical devices—such as wheelchairs, manual toothbrushes, and compression stockings—treated with antimicrobial preservatives were technically subject to both the Food and Drugs Act (FDA) and the PCPA. This dual oversight created regulatory inconsistency and uncertainty for industry, particularly because Class I devices do not require a medical device licence under the Medical Devices Regulations (MDR). Many manufacturers were unaware that the PCPA could apply, and Health Canada had not prioritized enforcement due to the limited risk posed by these products. 

The amendment updates clause 3(1)(h)(i)(D) of the regulations to explicitly exempt Class I medical devices treated with antimicrobial preservatives, as well as the antimicrobial preservatives themselves when used solely for preservation. As a result, all classes of medical devices are now regulated consistently when antimicrobials are used to protect the device material rather than to exert a pesticidal effect. 

Importantly, the change does not reduce regulatory oversight of medical devices. Class I devices remain fully subject to the FDA and MDR, which address safety, effectiveness, and quality requirements, along with other applicable legislation such as the Radiation Emitting Devices Act where relevant. Health Canada concluded that these frameworks adequately manage any potential health, safety, or environmental risks associated with antimicrobial-treated Class I devices. 

The amendment is expected to provide clear benefits by removing unnecessary regulatory duplication without imposing new costs or administrative burdens on industry, including small businesses. It formalizes existing regulatory practice, improves supply chain certainty, and aligns Canada’s approach more closely with that of the United States, where similar treated articles are exempt from pesticide registration requirements. 

The regulations came into force immediately upon publication on December 5, 2025. Overall, the amendment delivers greater clarity and consistency by confirming that Class I medical devices treated with antimicrobial preservatives are regulated exclusively as medical devices, while maintaining appropriate protections for human health and the environment.