A Policy Analysis to Inform Options for Medical Device Regulation and Post-Market Surveillance in the Canadian Context

With ageing populations and rising rates of chronic diseases, medical devices are increasingly vital components of health care. From tongue depressors and stethoscopes to pacemakers and medical robotics, medical devices are numerous, diverse and constantly evolving, integrating medicine, biomechanics, materials, software, and electronics in their development and application (Chen et al., 2018). However, while innovation is generally beneficial for patients, the complexity and diversity of medical devices poses a challenge for regulatory systems across the globe, which are often slow to adapt to the increasing complexity of medical devices, unpredictable risks, and emerging threats to public health (Curfman and Redberg, 2011; Mishra, 2017; Chen et al., 2018). Consequently, with medical device failures and malfunctions appearing in media and academic journals there is a global push for stricter regulatory reform and harmonization of regulatory frameworks internationally (Curfman and Redberg, 2011; Altenstetter, 2012; Maak & Wylie, 2016; Chen et al., 2018). This capstone will review and compare the regulatory frameworks for three jurisdictions (Canada, the United States and the European Union) with an aim of identifying post-market strategies which could be applicable to the Canadian context. Additionally the current and proposed changes to the Canadian medical device regulations will be discussed and analysed across multiple dimensions (burdens on various actors, innovation vs regulatory oversight and health risk protection) and, the 3-I framework will be used to deepen the understanding behind the shift in regulatory approach that Health Canada is working to implement. Lastly, based on the regulatory approaches compared and analysed it will provide an informed opinion on the approach that Health Canada is taking.