Health Canada has announced the creation of a new Medical Devices Directorate (MDD). This was done in order to account for and accurately reflect the current medical device industry, which has evolved drastically over the past several years. The new Directorate will aim to position Health Canada to be more focussed on the rapidly evolving field of medical devices, and “more agile and adaptable to its rapid growth and change” as well as allow them to “focus on, and grow, the medical device program to greater and more effective heights”, according to a letter released to their stakeholders last month.
Health Canada has stated that the Medical Devices Directorate will take a life cycle approach to regulating medical devices. In particular, it will “bring together specific post-market functions now led by the Marketed Health Products Directorate, with the pre-market functions of the Therapeutic Products Directorate.” The intent of this approach is to create an organization that uses modernised processes to be able to respond to rapid innovation cycles, increases scientific and policy capacity across the medical device life cycle, and better aligns Canada with our international counterparts. Health Canada has also stated that the Directorate will “allow for a much greater emphasis to be placed on expanding Quality Management Systems to include both internal and external components, and the implementation of ISO 9001, as well as enable better postmarket surveillance capacity for devices”.
The Canadian federal government has implemented several other policy initiatives, including the Regulatory Review of Drugs and Devices (R2D2), the Medical Devices Action Plan (MDAP), and the Treasury Board’s Regulatory Review (RR), that all aim to increase focus on medical devices and, more specifically, the management of medical devices across their life cycles. Combined, these initiatives, along with the Medical Devices Directorate will create a system that is dedicated to the regulation of medical devices and to “improving the safety, oversight and quality” of the medical device landscape, according to a Regulatory Focus article on the issue.
More information from Health Canada on the Medical Devices Directorate can be found here.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.