Tuesday, November 29, 2022

New Medical Device Regulations! What do you need to know?

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Medical Devices Regulation in Canada Principles and Recent Updates Workshop

December 9, 2022 | 9:00AM - 5:00PM


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
  • Quality systems according to ISO 13485:2016
  • GMP
  • Risk management according to ISO 14791
  • Clinical trials
  • Vigilance program
  • Preparation for audits in compliance with Health Canada requirements
  • New Canadian regulatory requirements
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Academy of Applied Pharmaceutical Sciences

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