Class I, II, III, or IV? - Health Canada Classification Service for Medical & Surgical Devices/IVD/POCT-NPT/SaMD

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What is the Health Canada device class for your medical & surgical devices/IVD/POCT-NPT/SaMD? 

How have you confirmed the accuracy of this information, specific to Canada?  

How we can help:

With our team’s 2,000+ projects & services and 25+ years in-depth Canadian market commercial and Health Canada regulatory expertise, we are fully positioned to help our clients from all over the world with virtually any project for the Canadian market, including Health Canada Classification. We offer our professional service to help clients determine Health Canada class for their medical & surgical devices, in-vitro diagnostic (IVD) devices, point-of-care (POCT) or near-patient-testing (NPT) devices, or Software as a Medical Device (SaMD) products. This includes obtaining direct confirmation from Health Canada on the Canadian device class. To provide our clients with the maximum possible certainty, we:

  • Review & analyze the client’s device information

  • Apply & interpret Health Canada classification rules applicable to the client devices

  • Recommend a preliminary device classification to Health Canada

  • Respond to Health Canada questions

  • Facilitate a formal classification ruling for medical devices directly from Health Canada

  • Report back to the client

  • Address any client questions

Because our service entails obtaining a formal confirmation from Health Canada for the medical device classification, it means there will be no ambiguity and our clients can therefore enjoy the maximum possible confidence in the accuracy of the medical device classification.

Background:

In Canada, Health Canada is the regulatory authority responsible for regulating medical devices. Health Canada classifies all medical devices into one of the following four classes i.e. Class I (lowest risk), Class II, Class III, and Class IV (highest risk).

Medical device classifications of medical devices in jurisdictions outside Canada e.g. US FDA or CE etc. do not apply to Canada. In fact, it is not uncommon for a medical device to be classified differently between Canada and other international jurisdictions. The device classification for Canada must be based on the risk-based classification approach specified by Health Canada. Health Canada holds the medical device manufacturers, importers, and distributors as accountable to correctly classify their medical devices as per Health Canada regulations. Sometimes people can assume that the Health Canada medical device class for their product(s) will be similar to that in the USA or Western Europe. This can result in significant avoidable costs, delays, liability exposure, and business disruption.  

Therefore, it is crucial that manufacturers, importers, or distributors accurately classify all their medical devices specific to Health Canada rules and regulations. 

More information?

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