Class I Medical Devices Exempt from Pesticide Rules

Summary#

The final rule Regulations Amending the Pest Control Products Regulations (Class I Medical Devices treated with Antimicrobial Preservatives) (SOR/2025-262) removes pesticide rules that previously also applied to low-risk medical devices treated with preservatives. It takes effect on publication in the Canada Gazette, Part II (published December 17, 2025) and formally exempts Class I medical devices treated with antimicrobial preservatives from the Pest Control Products Regulations.

What it does#

• Changes the wording of the Pest Control Products Regulations so that items defined as Class I medical devices are not treated as pest control products just because they were given an antimicrobial preservative during manufacture.
• Also exempts the antimicrobial preservative itself when it is used to treat those Class I devices.
• This expands an earlier exemption that already covered Class II, Class III, and Class IV medical devices, so all medical device classes are now treated consistently.
• The amendment comes into force on the day it was published in the Canada Gazette, Part II (publication date: December 17, 2025).

Who's affected#

• Manufacturers, importers and sellers of Class I medical devices (examples: some wheelchairs, toothbrushes, compression stockings) that include an antimicrobial preservative.
• Suppliers of antimicrobial preservatives used in those devices.
• The medical devices sector and the pest control products industry may notice clearer rules about which law applies.
• Health Canada and the Pest Management Regulatory Agency will update guidance and internal procedures to reflect the change.

Why it matters#

• It removes overlapping rules that could have forced some makers to meet two sets of requirements for the same product. That overlap had the potential to disrupt supply chains or slow sales while companies sorted compliance.
• The change mostly formalizes how things have been handled in practice and aims to give industry clearer, simpler regulatory expectations.
• Health Canada says the safety and environmental risks of antimicrobial-treated Class I devices can be managed under the Food and Drugs Act and the Medical Devices Regulations, so the pesticide rules are not needed for these products.
• The government received 4 formal comments on the proposal and ran a webinar with 54 attendees; no opposition was reported. The department expects no new costs for industry and only small implementation updates for government guidance.