The Regulations Amending the Pest Control Products Regulations (Class I Medical Devices treated with Antimicrobial Preservatives), SOR/2025-262, address the regulatory overlap between the Pest Control Products Act (PCPA) and the Food and Drugs Act (FDA) with respect to Class I medical devices. Prior to this amendment, devices such as wheelchairs, manual toothbrushes, and compression stockings that were treated with antimicrobial preservatives were regulated under both frameworks. The amendment clarifies that Class I medical devices treated with antimicrobial preservatives are exempt from PCPA requirements, while continuing to fall under FDA oversight and the Medical Devices Regulations (MDR).

The PCPA establishes federal authority to regulate pest control products, defined broadly as substances, organisms, or products used to control, repel, or mitigate the effects of pests. These include antimicrobials, insecticides, herbicides, fungicides, and other similar substances. Pest control products are subject to pre-market assessment to evaluate risks to human health and the environment and to determine product value. Registered products remain under post-market controls, including compliance monitoring, incident reporting, re-evaluations, and special reviews. Antimicrobial preservatives are considered pest control products when added to materials or articles to prevent microbial damage, extending the durability or shelf life of items. A treated article is defined as an inanimate product or substance, excluding food, whose primary purpose was not pesticidal before treatment.

Medical devices, as defined in the MDR, encompass instruments or products used to diagnose, treat, or prevent disease. Devices are classified into four risk-based classes, with Class I representing the lowest risk. While all devices must meet safety and effectiveness standards, Class I devices do not require a medical device licence prior to sale, unlike higher-risk Class II, III, or IV devices. The 2022 amendments to the PCPR, through SOR/2022-241, had already exempted most antimicrobial preservatives used in treated articles regulated under the FDA, including Class II, III, and IV medical devices, but did not include Class I devices.

In response, Health Canada conducted a detailed analysis to assess whether exempting Class I medical devices and the associated antimicrobial preservatives from the PCPA would compromise safety or environmental protection. The agency determined that the FDA and MDR frameworks sufficiently address the risks associated with antimicrobial-treated Class I medical devices, making PCPA oversight redundant.

Specifically, clause 3(1)(h)(i)(D) of the Pest Control Products Regulations has been revised to explicitly exempt Class I medical devices treated with antimicrobial preservatives from the PCPA. This change also exempts the antimicrobial preservative itself when applied to such devices, aligning Class I devices with previously exempted Class II, III, and IV devices.

Canada (262/2025) February 3, 2026
Disclaimer: Insights are for informational purposes only and does not reflect RRI’s official position or constitute legal opinion.