As part of an initiative to improve regulatory reviews, Health Canada aims to provide a new formal process for device firms seeking early advice.
The regulatory authority is calling on device manufacturers to provide feedback—prior to finalizing the process—via a pilot project that will help shape the guidance on as well as the definition and design of the meeting framework, dubbed, “Device Advice: Pre-Clinical Meetings.”
“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,” the regulatory authority said in a recent notice
Earlier interactions between manufacturers and agency staff on evidence requirements and investigational testing protocol designs intend to improve the quality of device submissions for more timely regulatory decisions and patient access to devices in Canada.
Manufacturers planning to submit an investigational testing authorization 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 set to run between November 2018 and March 2019.
A selected investigation site in Canada and a detailed clinical investigation protocol are required as well. Yet the demand will dictate whether all those that apply will be selected for the pilot.
The pilot timeline slightly differs from what had been proposed as part of the ongoing initiative for improved regulatory reviews of drugs and devices. The initial targets
involved initiating the pre-clinical meeting pilot this month and completing it by June 2019, followed by new guidance.
“We expect that all parts of the project will be fully in place by May 2020,” Health Canada said.
Under the five-year initiative on regulatory review, other projects launched in recent months include
the establishment of a new digital health division and several proposed changes to boost postmarket surveillance and risk management. The latter falls under the umbrella project
through which Health Canada intends to enhance its use of real-world evidence on devices.
The work coincides with other efforts that fall outside of the scope of the initiative. Earlier this year, Health Canada announced plans to transition to the Global Medical Device Nomenclature
and adopt the Table of Contents format
for harmonization of medical device applications.