Health Canada medical device regulations follows a risk-based regimen for the regulation of medical devices. Reviews cover a risk assessment of the use of the device presents or could potentially present.
Medical Devices are clustered based on risk into four classes 1-4 based on risk with Class I devices presenting the lowest potential risk (e.g. a tongue depressor) and Class IV devices presenting the greatest potential risk (e.g. a pacemaker).
Class I to IV medical devices
Class II, III, and IV medical devices have a Medical Device License to be sold in Canada, while companies selling Class I medical devices in Canada are required to have a Medical Device Establishment License (MDEL).
Medical devices in Canada are regulated by The Food and Drugs Act (R.S.C., 1985, c. F-27) which covers food, drugs, cosmetics, and devices.
The regulation specifically for devices is Medical Devices Regulations (SOR/98-282) which includes classification, manufacturer’s obligations, associated fees, labeling requirements, establishment license, incident reporting, recalls among other requirements.
The regulations are updated often with the most recent update to the regulation was Interim Order No. 3, Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.
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Below is a sample of the range of services that Arcus has provided to clients.
- A survey of 2,350 consumers and 1,320 business leaders for feedback on sustainability trends
- Architecting a multi-year change strategy for a Fortune 500 company
- Mentoring a CEO on organizational change
- Excellence transformation of a leading B2B services company
- Creating a new sales deployment model for a healthcare company
- Developing a position evaluation and compensation model for a professional medical association
- Improving services to customer segments by deepening their understanding of customer attitudes
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