Key Success Factor #2: Avoid costly assumptions. Recognize crucial regulatory differences between Canada and other major markets e.g. USA and Western Europe
Sometimes medical device manufacturers can assume that the Health Canada medical device class for their device(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.
The fact is that Health Canada classifies medical devices independently of other jurisdictions. Therefore, as a manufacturer, it is crucial to accurately classify your medical devices specific to Health Canada rules and regulations.
To provide you with the maximum possible certainty, we offer our professional services to interpret your device information, apply Health Canada rules, recommend a device classification, and facilitate a formal classification ruling for medical devices directly from Health Canada.