Health Canada publishes guidance for determining medical device application type
As we previously reported, Health Canada completed consultation on its draft guidance for determining medical device application type. The Medical Devices Regulations (MDR) outline five scenarios in which a medical device, including components or parts, is deemed licensed following one successful licence application under Part 1 of the MDR or is deemed authorized following one successful authorization application under Part 1.1 of the MDR.
In August 2025, Health Canada released the Guidance for determining medical device application type. This document provides guidance to manufacturers on whether their medical devices, including components and parts, can be combined and submitted as a single device licence or authorization application using one of five application types. The five application types addressed in the guidance document are:
- Medical device family
- Medical device group
- Medical device group family
- System
- Test kit
This guidance only applies to medical devices that are subject to both the Food and Drugs Act and the MDR. For example, veterinary medical devices are not within the scope of this guidance because they are only subject to provisions of the Food and Drugs Act.
In the guidance document, Health Canada outlines the criteria for each application type and provides examples of medical devices that meet these criteria. The guidance document addresses application types that apply to manufacturers of non-in vitro diagnostic devices and in vitro diagnostic devices. Health Canada also recommends that disinfectants classified as medical devices be licensed or authorized as single medical devices if they are intended for general use.
Medical Devices Directorate Annual and Quarterly Performance Reports
In September 2025, Health Canada released the Medical Devices Directorate Performance Annual Report for April 1, 2024 through March 31, 2025 and the Quarterly Report for Q1 2025-2026 (April through June 2025). These reports provide data on the processing times for pre-market medical device review as compared to service standards. For each class of medical devices, the reports include the number of applications received, the number of licences issued and the percentage of decisions made within performance targets.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.