Medical Devices Classification Tool/

Medical Device Classification Tool

This tool is intended to assist you with the classification of your medical device by walking through the classification rules found in Schedule 1 of the Medical Devices Regulations.

It is only intended to classify products that meet the definition of a “device” in the Food and Drugs Act and a “medical device” into Class I, II, III or IV.

It will **not** determine whether your product is *not* a medical device or if it falls under another category (e.g., drug, consumer product). Users must confirm that their product meets the definition of a “medical device” before proceeding.

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'Click below to launch the Classification Tool'

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Please note: The tool provides classification guidance **based strictly on your inputs** and should **not** be taken as a final decision by Health Canada.

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Guidance Documents

The following documents provide definitions, examples, and additional information:

• Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices
• Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices

For Software as a Medical Device (SaMD):

• SaMD: Definition and Classification
• SaMD: Classification Examples