Class I Medical Devices Canada: Set to Be Exempt from PMRA Regulations – What You Need to Know 

In a significant regulatory update, Health Canada’s Pest Management Regulatory Agency (PMRA) has announced its intention to exempt antimicrobial-treated Class I medical devices from the Pest Control Products Regulations (PCPR). This change is a response to concerns raised by stakeholders following the 2022 amendments to the PCPR, which introduced new compliance requirements for non-food articles treated with antimicrobial preservatives, ensuring that each licensed medical device meets specific regulatory standards and keeps the Minister informed of any changes or concerns regarding their safety and effectiveness. 

This blog breaks down what’s changing, why it matters, and what medical device manufacturers need to know to stay compliant. 

Introduction to Medical Devices and their Regulatory Framework 

Medical devices are indispensable in modern healthcare, playing a pivotal role in diagnosis, treatment, and patient care. To ensure these devices are safe and effective, they are regulated under the Medical Devices Regulations, which fall under the Food and Drugs Act. These regulations provide a comprehensive framework governing the sale, advertising, and importation of medical devices in Canada. They set stringent requirements for the safety and effectiveness of medical devices, covering aspects such as design, manufacturing processes, and labeling. By adhering to these regulations, manufacturers can ensure their products meet the necessary standards to protect public health and safety. Health Canada’s Medical Devices Directorate is the body responsible for administering this regulatory framework. Their duties include the licensing of medical devices, setting safety and effectiveness requirements, and monitoring adverse events related to medical devices. 

Background: 2022 Amendments to the Pest Control Products Regulations 

In December 2022, Health Canada introduced regulatory amendments to the PCPR, expanding the scope of regulated treated articles—defined as non-food products that have been treated with or intentionally incorporate an antimicrobial preservative. While several categories of products were exempted from the amended regulations—such as foods, drugs, cosmetics, natural health products (NHPs), and Class II-IV medical devices—Class I medical devices were noticeably left out. 

Why Class I Medical Devices Were Affected 

In Canada, medical devices are classified into Class I, II, III, and IV. Class I medical devices are those that pose the lowest risk to human health and safety, such as tongue depressors, bandages, and examination gloves. With the updated regulations, Class I medical devices treated with antimicrobials were technically subject to PMRA registration. This meant that both the antimicrobial preservative and the device itself required compliance with PCPR registration protocols, increasing the administrative burden for manufacturers. 

Common examples of Class I medical devices treated with antimicrobials include: 

• Face masks 

• Medical gauze and gowns 

• Syringes 

• Nasal sprays 

• Ultrasound gels 

• Oral care devices (toothbrushes, dental floss) 

• Dental adhesives 

• Swimming pool devices 

Industry Pushback and Regulatory Consultations 

Throughout 2024, extensive consultation sessions between the PMRA and medical device industry stakeholders revealed the potential impact of the regulation: 

• 25% or more of Class I medical devices could be affected 

• PMRA registration could create a duplicative regulatory burden and increase regulatory uncertainty for manufacturers determining whether their products fit into specific categories under the Pest Control Products Regulations 

• The additional compliance costs and resource strain could delay market access for essential medical supplies 

In February 2025, the PMRA announced its proposed amendment to exempt antimicrobial-treated Class I medical devices from the PCPR, aligning them with the current exemption already granted to Class II, III, and IV medical devices. 

What’s Next: Timeline for Regulatory Updates 

The PMRA has confirmed the following timeline for implementation: 

• Spring 2025: A Notice of Intent and public consultation webinar will be held as part of the formal consultation process 

• Fall 2025: Proposed exemption expected to be published in the Canada Gazette, Part I 

Stakeholders are encouraged to participate in the upcoming consultation process to provide feedback on the proposed exemption. These amendments also aim to ensure safety and efficacy in drinking water treatment systems. 

Compliance Implications for Medical Device Manufacturers 

Until the exemption is officially enacted, Class I medical devices treated with antimicrobials technically remain under PMRA jurisdiction. Manufacturers should continue to: 

• Monitor PMRA updates and CG publications 

• Evaluate whether current or upcoming products fall under the PCPR scope 

• Maintain documentation for ingredient safety and antimicrobial use as part of their quality management system 

• Ensure that quality management system (QMS) certificates (MDSAP) are maintained in compliance with international standards 

• Prepare for any transitional compliance requirements 

Class II, III, or IV medical devices have specific licensing conditions, obligations for post-market reporting, and the need for detailed annual reviews and documentation. 

Dell Tech Can Help You Stay Ahead of Regulatory Changes 

At Dell Tech, we offer comprehensive regulatory consulting for PMRA-regulated products and medical devices in Canada. Whether you need assistance interpreting the PCPR, updating your compliance protocols, or preparing for the upcoming exemption, our experts are here to help. 

📩 Contact us today for guidance or sign up for our monthly regulatory newsletter to stay ahead of Health Canada updates. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.