Medical Device Classification Tool

Find below the Medical Device Classification Tool.

The classification of medical devices approved by Health Canada is described in the Guidance Document: Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs).

Important

This tool helps you determine the class of a medical device. It does not replace the official interpretation of the Guidance Document, but aims to facilitate its understanding and application.

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Find below the Medical Device Classification Tool.

Important

Are you a sponsor or a biotechnology company with a clinical research project?

Efficient Regulatory Assessment

Medical Device Classification Tool

Find below the Medical Device Classification Tool.

Important

Are you a sponsor or a biotechnology company with a clinical research project?

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