Notice: Device Advice: Health Canada launching a new pilot project to formalise a framework aimed at offering regulatory advice to medical device manufacturers

September 5, 2018
Our file number: 18-110819-613

Under the "Regulatory Review of Drugs and Devices" initiative, Health Canada intends to make the regulatory system more efficient and to support timely access to therapeutic products.

As part of this initiative, Health Canada is pleased to announce that it is now in the process of formalising a meeting framework called "Device Advice: Pre-Clinical Meetings", where medical device manufacturers will be able to receive advice and recommendations on their investigational testing protocols. In light of stakeholder feedback, Health Canada determined that there is a lack of guidance with regards to Pre-Clinical Meeting requests, and that the criteria under which they can be requested are not well defined.

A formal Pre-Clinical Meeting process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. Our aim is to develop and implement processes that facilitate effective communication between medical device manufacturers and Health Canada in order to improve the quality of submissions and provide more timely regulatory decisions.

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.

Seeking participants for the Device Advice: Pre-Clinical Meeting Pilot

In order to launch the pilot in November 2018, Health Canada is seeking expressions of interest from manufacturers. If you are 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, you are eligible to participate in the pilot if you have:

• a selected Canadian investigation site, and
• 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 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.

Depending on demand, not all interested manufacturers may be selected for the pilot. Applicants will be informed via email as to whether or not they have been selected for the pilot project.

Health Canada expects that this initiative will result in earlier interactions with manufacturers, resulting in more timely and positive regulatory decisions. This will ultimately benefit Canadian patients and the health care system by improving timely access to medical devices in Canada.

Please submit your expression of interest to the Medical Devices Bureau by September 21, 2018 at: meddevices-instrumentsmed@hc-sc.gc.ca.

Questions or concerns regarding this notice should be directed to meddevices-instrumentsmed@hc-sc.gc.ca.