In Depth: Canada Medical Device Approval and Compliance


With 35,000,000 people and a well organized healthcare system, Canada is an excellent market for medical device manufacturers. However, many people incorrectly assume that Health Canada's approval process is much like the US FDA. Not true! In fact, the Canadian medical device registration system is more similar to that in Europe. We'll explain the Canadian approval process step by step in this free video. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of June 2014. You will learn:

  1. Overview of the Canadian market and regulatory framework [4:37]
  2. The steps involved in classifying your medical device in Canada [4:02]
  3. Quality Management System requirements in Canada [3:13]
  4. Product testing and clinical data requirements in Canada [2:28]
  5. Dossier preparation and registration in Canada [6:28]

Total run time: 22 minutes