Medical device manufacturers in Canada now have updated guidance to help navigate application types under the Medical Devices Regulations. Health Canada has released detailed insights into determining when medical devices can be grouped in a single application — an important update for regulatory, clinical, and quality teams managing device submissions.
What changed?
On August 29, 2025, Health Canada introduced updates to assist manufacturers in accurately identifying application types under the Medical Devices Regulations. This guidance clarifies when different medical devices may be grouped and submitted as one application, streamlining the approval process for manufacturers.
The updates address critical considerations for compliance, including device compatibility, functionality, and associated risks. These revisions aim to ensure efficiency while maintaining safety and performance standards for approved devices.
What are the application types?
The Medical Devices Regulations outline several application types that manufacturers must follow when submitting devices for approval. These include:
- Class II, III, and IV applications: Representing medium- to high-risk devices, these applications require specific evidence demonstrating safety, performance, and intended purpose.
- Amendment applications: For circumstances where changes to an already approved device affect its safety, effectiveness, or intended use.
- Combination applications: Used for devices meant to perform complementary functions or integrate into one system.
Understanding the relevance of each type is crucial for manufacturers to avoid delays and ensure compliance with regulatory requirements.
How can devices be combined into one application?
Manufacturers are encouraged by Health Canada to group devices under a single application when certain conditions are met. These conditions may include:
- Devices share a common intended purpose or functionality.
- Harmonized compatibility ensures safe use alongside one another.
- Risk assessments confirm no additional hazards when devices are used together.
For example, a diagnostic system comprising a reader, software, and disposable test cartridges could be submitted as one application. However, clear evidence showing compatibility and cohesive function must be presented.
This approach reduces administrative burdens for manufacturers and regulatory authorities while ensuring the safety and performance of combined devices.
Frequently asked questions
- Q: What if a device is used across multiple functions?
A: Manufacturers must specify the primary intended purpose and ensure regulatory evidence supports each function. - Q: Is pre-market notification required for all application types?
A: Typically, Class III and IV devices require notification. Lower-risk devices may have different requirements outlined in the guidance. - Q: Can I submit multiple amendment requests for one device?
A: Yes, but each amendment must clearly justify its regulatory impact and align with safety or performance improvements.
Conclusion
Health Canada’s latest guidance simplifies decision-making for medical device manufacturers, helping them identify correct application pathways and opportunities to streamline submissions. Understanding the nuances of grouping devices in a single application is vital for achieving compliance and optimizing regulatory processes.
Manufacturers should closely evaluate their devices’ intended purposes, safety profiles, and compatibility before proceeding with grouped applications.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal or regulatory advice. Manufacturers are encouraged to consult with qualified professionals to address their specific compliance needs.
Health Canada reference
For full information about the announcement, see the link below.