Device Advice: Health Canada Launching a New Pilot Project to Formalize Regulatory Advice Framework for Medical Device ManufacturersPublished on November 6, 2018
Author: Bhavesh Patel, C. Chem.
Health Canada recently announced it is the process of formalizing a meeting framework called "Device Advice: Pre-Clinical Meetings", where medical device manufacturers will be able to receive advice and recommendations for investigational testing protocols.
As a first step, Health Canada is launching a pilot called "Device Advice: Pre-Clinical Meetings". The pilot is expected to run from November 2018 to March 2019. Participation in the pilot will provide manufacturers an opportunity to benefit from pre-clinical meetings as well as to contribute in the definition and design of the pre-clinical meeting framework and guidance material. The pilot phase will enable Health Canada to develop a new guidance document for pre-clinical meetings including defined processes, timelines, and information required to request such meetings.
To launch the pilot in November 2018, Health Canada is seeking expressions of interest from manufacturers. Manufacturers planning on submitting an Investigational Testing Authorization (ITA) application for a Class III or IV device, or a Class II device that could be considered a novel or disruptive technology, may be eligible to participate in the pilot provided that they have selected a Canadian investigation site, and prepared a detailed clinical investigation protocol.
Expressions of interest to participate in the pilot should be submitted in the form of a cover letter including the following information:
· three proposed dates and times for the meeting request during the above-mentioned timeframe for the pilot;
· location of the investigational site;
· synopsis of proposed study;
· a list of preliminary questions to be addressed by the Medical Devices Bureau and sufficient information relating to the issues to be discussed to ensure attendance of the relevant staff necessary to discuss the proposed issues.
Not all interested manufacturers may be selected for the pilot depending on demand. Applicants will be informed via email as to whether or not they have been selected for the pilot project.
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