Health Canada recently announced the creation of a new Medical Devices Directorate (MDD), to address the challenges and opportunities relating to the ever-changing landscape of the medical device industry.
The new MDD will take a “lifecycle approach” by bringing together post-market functions led by the Marketed Health Products Directorate, and pre-market functions led by the Therapeutic Products Directorate. This will essentially create an organisation which is dedicated to medical device regulation.
The new organisation will aim to enhance scientific and policy capacity, modernise processes to respond to rapid innovation, and increase resources to support transparency and stakeholder engagement activities across the medical device life cycle. It will rely on the convergence of medical device experts from both the pre- and post-market, allowing them to forge relationships, and exchange knowledge. They will strive to optimise collaboration with internal, national, and international medical device stakeholders through outreach activities, and policy and regulatory initiatives.
Life cycle management of medical devices is an international best practice. The new MDD will align the Canadian regulatory device system with their international counterparts. Internationally, people rely on medical devices to maintain and improve their health and well-being. Although Canada has one of the best regulatory systems in the world for medical devices with some of the most stringent requirements, the pace of change is challenging.
This Directive will enable Health Canada to ensure that medical devices in Canada are safe, effective and of high quality, throughout their life cycles.
“Creating the MDD is a significant step in response to this challenge and sets up the medical devices program for a successful future.”
For more information on this new initiative, click here.