[2025-08-29] On August 29, 2025, Health Canada published new guidance for licence or authorization applications for groups of medical devices.
This new 32-page guide is entitled “Guidance for determining medical device application type”, and is available in its entirety online. It can also be downloaded in PDF format, should you wish to keep it as part of your documentation.
Purpose of the guidelines
The document provides guidance to manufacturers on presumptive approvals described in sections 28 to 31, Part 1 of the Medical Devices Regulations (SOR/98-282). Also included are the presumptions of authorization detailed in sections 68.05 to 68.09 of Part 1.1 of the same regulations.
Health Canada wants to ensure that manufacturers have the necessary guidelines to determine:
- whether their medical devices, including components and parts, can be combined and submitted under a single application;
- the type of application, i.e. a medical device family, a medical device group, a medical device group family, a system, a test kit or a single-item medical device application.
The different types of request
Before getting to the heart of the matter, the guidelines recall several essential definitions. They then deal with the different types of application, divided into two main sections:
- the first for medical devices other than in vitro diagnostic devices (IVDDs):
- single medical devices;
- medical device families (same manufacturer, with minor variations, same design and manufacturing processes, same intended use, and similar risks);
- medical device assemblies (grouping sold under a single identifier, even if the components of the assembly come from different manufacturers, and the components cannot be sold individually without a separate application);
- medical device group families (same manufacturer, same generic name and same intended use, variations limited to the number or combination of products);
- medical device systems (composed of parts designed to work together, generally bearing a single brand or generic name, with functional cohesion).
- the second for IVDDs:
- single IVD medical devices;
- test kits (same intended use, same test model, same reagent formula);
- IVDD families (same manufacturer, same design and manufacturing processes, same intended use and supporting evidence, differences limited to size and/or concentration, and possibly different brand names)
- Medical device systems for IVDDs (composed of parts designed to work together, generally bearing a single brand or generic name, with functional cohesion).
Each category is carefully defined, with precise inclusion criteria for each category. Several practical examples help to distinguish the relevant categories.
A separate final chapter deals with the special case of disinfectants classified as medical devices.
Conclusion
This document clarifies the criteria by which medical device manufacturers in Canada can choose the type of application (single medical device, family, group, family group, system, test kit) to submit to Health Canada. The objective is simple: to optimize regulatory compliance and the efficiency of the conformity assessment process.
Article written by Christophe Saillet, member of the DMEXPERTS network.