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Notice of Intent NOI2025-01, Regulations Amending the Pest Control Products Regulations (Antimicrobial-treated Class I Medical Devices)

Notice to the reader:

The online consultation is now closed.

Health Canada – Pest Management Regulatory Agency
2 June 2025
(PDF Version - 278 KB)

Table of contents

1.0 Purpose

The purpose of this notice is to inform stakeholders and people in Canada that Health Canada is seeking feedback on a proposed amendment to the Pest Control Products Regulations. The amendment would exempt Class I medical devices (for example, wheelchairs, manual toothbrushes, compression stockings) treated with antimicrobial preservatives as well as the corresponding antimicrobials when used to treat those devices, from the Pest Control Products Act, as it has been determined that the risks of these products are adequately addressed under the Food and Drugs Act and the Medical Devices Regulations.The proposed amendment would expand the existing exemption for antimicrobial treated Class II, III and IV medical devices. Stakeholders and people in Canada are invited to send their comments on the proposed amendment up to 30 days from the date of publication of this document.

2.0 Context

The federal pesticide regulatory system in Canada aims to protect human health and the environment from the risks of pesticides. Health Canada's Pest Management Regulatory Agency is the federal government authority responsible for the regulation of pesticides. The Pest Control Products Act and its regulations provide the legislative framework for the regulation of pesticides federally.

Antimicrobial preservatives are pest control products that are used to extend the durability or shelf life of an article or material, by controlling micro-organisms that may degrade or damage that item (preservation). A treated article is an inanimate product (excluding food) that is treated with a pest control product. Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1 of the Medical Devices Regulations, where Class I represents the lowest risk and Class IV represents the highest risk. Additionally, the Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices intends to clarify the application of the risk classification rules set out in the Medical Devices Regulations for non-in vitro diagnostic devices. The risk classification scheme was developed to categorize medical devices according to the hazard a particular device presents and not the probability that harm will occur.

Section 3 of the Pest Control Products Regulations exempts certain pest control products from the application of the Pest Control Products Act. For example, this section exempts an antimicrobial preservative from the Pest Control Products Act when it is used in the manufacture of a treated article that is a medical device that is classified as a Class II, III or IV medical device under the Medical Devices Regulations. Class II, III or IV medical devices treated with such an antimicrobial are also exempt from the Pest Control Products Act under this section.

On 30 November 2018, Health Canada published a regulatory pre-consultation proposal, the summary of which is available online (PRO2018-03, Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Product Exemptions) - Summary). This proposal included proposed amendments that would have exempted treated articles treated with antimicrobial preservatives from registration under the Pest Control Products Act, under certain conditions. The consultation period lasted 90 days.

Subsequently, on 28 October 2020, Health Canada sent industry stakeholders, non-governmental organizations, Indigenous organizations, and federal/provincial/territorial partners a regulatory pre-consultation discussion document entitled "Pre-Consultation – Proposed Amendments to the Pest Control Products Regulations (Applications and Imports)". This document included a proposal to exempt certain antimicrobial preservatives (and the article being treated) from the application of the Pest Control Products Act when used to treat certain products regulated under the Food and Drugs Act (i.e., drugs and cosmetics), the Feeds Act, or the Fertilizers Act. The consultation period lasted 75 days.

The proposed regulatory amendments were also pre-published in the Canada Gazette, Part I, on 2 April 2022, followed by a 70-day comment period. The pre-publication likewise proposed to exempt certain antimicrobial preservatives (and the article being treated) used to treat certain products regulated under the Food and Drugs Act (in other words, drugs and cosmetics), Feeds Act or the Fertilizers Act.

Following these consultations, the Pest Control Products Regulations was amended to, among other things, exempt certain antimicrobial preservatives (and the article being treated) from the application of the Pest Control Products Act, when they are used to treat drugs, cosmetics, or Class II, III or IV medical devices under the Medical Devices Regulations. Amendments for SOR/2022-241, Regulations Amending the Pest Control Products Regulations (Applications and Imports came into force on 5 June 2023. Antimicrobial treated Class I medical devices remained subject to the Pest Control Products Act.

Following the Canada Gazette, Part II publication, in response to stakeholder feedback, Health Canada re-examined whether exempting Class I medical devices treated with an antimicrobial preservative, and the corresponding antimicrobial when used to treat those devices, from the Pest Control Products Act would be consistent with the objectives of the Act. It was determined that potential health and environmental risks associated with antimicrobial treated Class I medical devices are adequately addressed under the Food and Drugs Act and the Medical Devices Regulations.

The proposed amendment is expected to reduce regulatory and administrative burden, and duplication, while maintaining health and environmental protection. All medical devices would continue be regulated under the Food and Drugs Act, Medical Devices Regulations and other legislation, as applicable (for example, Radiation Emitting Devices Act).

For information on other regulatory modernization efforts, please consult the Forward Regulatory Plan page on the Health Canada portion of the Canada.ca website.

3.0 Proposed amendment

Health Canada proposes to amend subsection 3(1) of the Pest Control Products Regulations to exempt Class I medical devices treated with an antimicrobial preservative and the antimicrobial preservative itself when used for this purpose from the application of the Pest Control Products Act, to avoid an unnecessary duplication of resources and burden on stakeholders. As a result of the proposed amendment, the Pest Control Products Act would not apply to Class I medical devices regulated under the Medical Devices Regulations that are treated with antimicrobial preservatives (i.e., in addition to antimicrobial treated Class II, III and IV medical devices already exempted, as described above).

The proposed amendment is anticipated to have no impact on stakeholders as it would align with current practice.

Views are requested on this proposal, particularly:

4.0 Next steps

Comments on this Notice of Intent from stakeholders and people in Canada can be provided up to 30 days from the date of publication of this document by:

A webinar will be offered to stakeholders during the comment period. Health Canada will consider all input gathered through this process, in anticipation of a formal publication in the Canada Gazette.

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2025-07-07