Health Canada has launched a pilot project which aims to provide a new formal process for device companies seeking early advice. A formal pre-clinical process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. The aim is to facilitate effective communication between medical device manufacturers and Health Canada to improve the quality of submissions and provide timely regulatory decisions.
Prior to finalising the process, Health Canada is asking device manufacturers to provide feedback via the pilot project named “Device Advice: Pre-Clinical Meetings”, which will help shape the guidance and design of the meeting framework. Device manufacturers who are planning to submit an investigational testing authorisation application for a Class III, IV or a Class II device that can be considered “a novel or disruptive technology” can apply to participate in the pilot, which is expected to run from November 2018 to March 2019.
From stakeholder feedback, Health Canada believes that there is a lack of guidance regarding pre-clinical meeting requests, and that the criteria under which they can be requested are not well defined.
Other projects that have recently been launched by Health Canada include the establishment of a new digital health division and several proposed changes to boost post-market surveillance and risk management.
To read more about Health Canada’s pilot project to formalise a framework which aims to offer regulatory advice to medical device manufacturers, please click here.