Medical Devices Regulation in Canada

– Principles and Recent Updates Workshop

Medical devices companies who develop their products and

wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices.

Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products.

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Course Outline

Introduction
Canadian regulations of medical devices
Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU)
Mutual recognition of data between various regulatory authorities
Preparation and submission of Pre-ITA, ITA, Licensing application