Regulations Amending the Pest Control Products Regulations (Class I Medical Devices treated with Antimicrobial Preservatives): SOR/2025-262

Canada Gazette, Part II, Volume 159, Number 26

Registration
SOR/2025-262 December 5, 2025

PEST CONTROL PRODUCTS ACT

P.C. 2025-894 December 5, 2025

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending the Pest Control Products Regulations (Class I Medical Devices treated with Antimicrobial Preservatives) under section 67footnote a of the Pest Control Products Actfootnote b.

Regulations Amending the Pest Control Products Regulations (Class I Medical Devices treated with Antimicrobial Preservatives)

Amendment

1 Clause 3(1)(h)(i)(D) of the Pest Control Products Regulationsfootnote 1 is replaced by the following:

Coming into Force

2 These Regulations come into force on the day on which they are published in Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Prior to this regulatory amendment, Class I medical devices (for example wheelchairs, manual toothbrushes, compression stockings) treated with an antimicrobial preservative were regulated under both the Pest Control Products Act (PCPA) and the Food and Drugs Act (FDA). This created overlapping requirements, uneven treatment across device classes and did not reflect how Class I devices had been treated in practice.

Background

The Minister of Health’s mandate under the PCPA is to prevent unacceptable risks to human health and the environment associated with the use of pest control products in Canada. The PCPA and its regulations provide the legislative framework for the federal regulation of pesticides. The PCPA requires the Minister of Health to conduct pre-market assessments of pest control products to determine if the risks to human health and the environment are acceptable and that the products have acceptable value. Once a pest control product has been registered, it becomes subject to a system of post-market risk management controls. This includes re-evaluations and special reviews, compliance and enforcement activities, and reporting of health and environmental incidents.

The definition of pest control product in the PCPA includes a product, an organism or a substance that is used as a means for, directly or indirectly, controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects. While the term “pesticide” is not used in the PCPA, it is often used to refer to a pest control product and covers a broad range of substances, including those commonly known as herbicides, insecticides, rodenticides, fungicides and antimicrobials.

Antimicrobial preservatives are pest control products added to materials or products to prevent microbes (tiny organisms like bacteria and mould) from causing damage, helping to extend the durability or shelf life of an item by preserving an item from deterioration or degradation. The Pest Control Products Regulations (PCPR) define treated article as an inanimate product or substance, excluding food, that is treated with a pest control product and whose primary purpose was not pesticidal before that treatment. Articles can be treated with pesticides such as antimicrobials (for example textiles treated with a preservative), insecticides (for example insecticide-treated clothing), and herbicides (for example herbicide-treated landscape fabric). A pesticide that has been intentionally incorporated into or applied to an article during manufacture for import, sale or use in Canada must be registered, authorized or exempted under the PCPA. Treated articles also need to be registered, authorized or exempted under the Act.

The term medical device, as defined in the Medical Devices Regulations (MDR), covers a wide range of health or medical instruments used to treat, diagnose or prevent diseases or other health problems in humans. The MDR outline the safety and effectiveness requirements for medical devices. Medical devices are grouped into four classes from Class I (lowest risk) to Class IV (highest risk) based on classification rules set out in Schedule 1 of the MDR. The Guidance Document – Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices helps explain how to apply Schedule 1 of the MDR to non-in vitro diagnostic devices (namely medical devices that are not used to test samples like blood or tissue outside the body). The Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices is also available, and helps to explain how to apply Schedule 1 of the MDR to in vitro diagnostic devices (such as analyzers, pregnancy/diagnostic test kits, and glucose metres).

In 2022 Heath Canada amended the PCPR through the Regulations Amending the Pest Control Products Regulations (Applications and Imports): SOR/2022-241 to address issues identified during a comprehensive review of the regulations. Among other changes, the amendments codified existing practice by exempting most antimicrobial preservatives used for preservation from the application of the PCPA, as well as the treated article itself, when those antimicrobials are used in treated articles regulated under the Feeds Act, the Fertilizers Act or the FDA. With respect to the FDA, this included drugs and cosmetics, as well as devices classified as a Class II, III or IV medical device under the MDR (e.g. catheters, wound dressings, contact lenses).

Under the MDR, while all medical devices must meet safety and effectiveness requirements, Class I medical devices, unlike other classes of medical devices, do not require a medical device licence prior to sale. For this reason, in 2022, Class I devices were not included in the exemptions granted to other medical devices, as they are subject to different regulatory requirements under the MDR.

Following the publication of SOR/2022-241, industry stakeholders raised concerns noting that they had not previously been aware that the PCPA applied to Class I medical devices and, therefore, had not been meeting the requirements of the PCPR. Specifically, they expressed concern that following rules from both the PCPR and the MDR for Class I medical devices could cause issues for the medical device supply chain, such as possibly needing to cease trade in such products (both raw material and finished goods) while verification activities required by the PCPR were performed. They stated that this could, in turn, potentially lead to certain devices or types of devices not being available on the Canadian market.

Given these concerns, Health Canada conducted a thorough analysis to determine whether exempting Class I medical devices treated with an antimicrobial preservative, and the corresponding antimicrobial when used to treat those devices, from the PCPA would be consistent with the objectives of the PCPA. After engaging internally with several experts with knowledge of the PCPA and MDR, Health Canada concluded that the potential health, safety and environmental risks associated with antimicrobial-treated Class I medical devices can be adequately addressed under the FDA and the MDR.

Objective

The amendment removes unnecessary regulatory requirements to reflect current practice, providing clarity and certainty for industry while maintaining health, safety, and environmental protection. All medical devices continue to be regulated under the FDA, the MDR and other legislation, as applicable (for example the Radiation Emitting Devices Act).

Description

Clause 3(1)(h)(i)(D) of the PCPR has been amended to exempt Class I medical devices treated with antimicrobial preservatives from the PCPA. This amendment also has the effect of exempting the antimicrobial preservative itself when it is used as a treatment in such devices. This represents an expansion of the previous exemption for antimicrobial-treated Class II, III and IV medical devices.

Regulatory development

Consultation

Following a re-examination of the issue of exempting antimicrobial-treated Class I medical devices from the PCPA, Health Canada published a Notice of Intent (NOI) on June 2, 2025, followed by a 30-day consultation period, to seek comments from stakeholders and the public on the regulatory amendment to exempt antimicrobial-treated Class I medical devices from the PCPA. Additionally, an information webinar was held for stakeholders and the public, with 54 attendees, on June 13, 2025, to provide clarification regarding the proposal to help inform comments on the NOI. An email was also sent to key stakeholders to inform them of the NOI and webinar, and a notice was sent to stakeholders who are subscribed to the Pesticides and Pest Management Really Simple Syndication (RSS) feed. Health Canada received a total of four comments through the NOI consultation. Industry stakeholders submitted a joint letter that expressed their continued support for the regulatory amendment. There were no comments opposing the amendment. Three of the comments were out of scope or not directly related to the amendment (for example a question about animal testing and a question asking exactly what products were being treated with what chemicals).

As the proposal maintains current health and safety standards, imposes no new regulatory burden, and pre-consultations with interested parties confirmed support with no concerns raised, it has been granted an exemption from the requirement to prepublish in the Canada Gazette, Part I.

Indigenous engagement, consultation and modern treaty obligations

No impacts have been identified in respect of the Government’s obligations in relation to Indigenous rights protected by section 35 of the Constitution Act, 1982, or its modern treaties, policy commitments and international human rights obligations.

Instrument choice

Health Canada conducted an analysis to evaluate whether the baseline scenario (no action), a change to policy, or a regulatory amendment would be the best option. Health Canada determined that the issue is best addressed by a regulatory amendment, as the baseline scenario and an exclusively policy-level approach would not address the issue identified by stakeholders or regulatory burden and overlap.

Regulatory analysis

It is anticipated that the regulatory amendment will result in net benefits to people in Canada, the medical devices industry, the pest control product industry, and the Government of Canada.

Baseline scenario

Prior to this regulatory amendment, Class I medical devices treated with antimicrobial preservatives, as well as the corresponding antimicrobials when used to treat those devices, were subject to registration under the PCPA, unless other authorization criteria applied. The PMRA has never received an application to register antimicrobial preservatives that are used to treat or be incorporated into a medical device. The cost-benefit analysis assesses impacts against a baseline scenario. For this analysis, the baseline scenario is one where Class I medical devices would be subject to both the PCPA and the FDA. However, it should be noted that following the publication of SOR/2022-241, stakeholders in the medical device industry indicated that they were not aware that their devices could be subject to the PCPA. Health Canada has not prioritized the enforcement of these regulatory requirements for such antimicrobial preservatives under the PCPA, as Health Canada determined that potential health, safety, and environmental risks associated with antimicrobial-treated Class I medical devices can be adequately addressed under the FDA and the MDR. The baseline is thus defined as one where industry would continue to only comply with the requirements under the MDR.

Regulatory scenario

The amendment exempts Class I medical devices treated with antimicrobial preservatives, as well as the corresponding antimicrobials used to treat those devices, from the PCPA. Therefore, under the regulatory scenario, industry is only required to comply with the applicable requirements under the MDR. It should be noted that this formalizes current regulatory practices.

Costs and benefits

Costs

The industry stated that it was not aware of the regulatory requirements for antimicrobial preservatives used to treat Class I medical devices under the PCPA, and the government was not prioritizing the enforcement of those requirements. Therefore, the regulatory amendment does not impose incremental costs on the medical device industry, as it only codifies current practices. It is anticipated that there will be minor implementation costs to the government in updating interpretive guidance.

Benefits
Provide regulatory clarity for the medical device industry

This amendment provides regulatory clarity for the medical device industry on the exemption of Class I medical devices treated with antimicrobial preservatives. It will also codify consistent regulatory treatment of all classes of medical devices treated with antimicrobial preservatives.

Small business lens

Analysis under the small business lens concluded that the proposed regulation does not impose any compliance or administrative impacts on Canadian small businesses.

One-for-one rule

The one-for-one rule does not apply, as there is no incremental change in administrative burden on business and no regulatory titles are repealed or introduced.

Regulatory cooperation and alignment

The federal rules under the PCPA apply nationally and permit/facilitate interprovincial trade. However, provinces and territories may impose requirements that are more restrictive than those under the PCPA; they cannot lessen the requirements under the PCPA. These requirements are therefore complementary and do not conflict with provincial or territorial requirements.

Canada’s regulatory approach of exempting antimicrobial-treated medical devices, as well as the corresponding antimicrobial preservatives used to treat them, from its pesticide-related regulation is similar to that of our major trading partner, the United States (U.S.). The U.S. Environmental Protection Agency (EPA) uses the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to regulate pesticides, and requires the registration of any substance intended to prevent, destroy, repel or mitigate pests. Treated articles, like medical devices, do not require registration, and are exempt from FIFRA, if the pesticide it is treated with is used to protect the article or substance itself and is registered for such use.

International obligations

There are no international agreements or obligations that pertain to this issue.

Effects on the environment

In accordance with the Cabinet Directive on Strategic Environmental and Economic Assessment (SEEA Directive), a preliminary scan concluded that a SEEA is not required.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for this amendment.

Implementation, compliance and enforcement, and service standards

Implementation

The regulatory amendment comes into force on the day on which it is published in the Canada Gazette, Part II.

Health Canada has updated the Questions and Answers – Treated Articles document to reflect the changes to the regulation of Class I antimicrobial-treated medical devices. Policies and guidance are not expected to be affected as a result of the regulatory change. Products that are exempt from the application of the PCPA are not conveyed through interpretive guidance; rather, they are set out in the regulations. In case of inquiries, internal standard operating procedures are used and will be updated as necessary.

Contact

Jordan Hancey
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2 Constellation Drive
Ottawa, Ontario
K1A 0K9
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca