Device advice for medical devices
This project will result in new and structured ways for Health Canada to engage and communicate effectively with medical device stakeholders. This will be done through pre-clinical meetings and an e-learning course.
We expect a formal meeting process to result in earlier interactions with device manufacturers. 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. This will result in medical devices reaching Canadians faster.
The tasks for this project include:
- develop e-learning tools (March 2018)
- start pre-clinical meeting pilot (September 2018)
- launch of e-learning tool (March 2019)
- complete pre-clinical meeting pilot (June 2019)
- develop pre-clinical meeting guidance document (June 2019)
- Public consultation on the draft guidance document: Device Advice: Medical Device Meetings (Spring 2020)
We expect that all parts of the project will be fully in place by June 2020.
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