Health Canada to Offer Pre-clinical Advisory Meetings to Medical Device Manufacturers
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- Health Canada’s Pre-Clinical Meeting program to provide feedback and recommendations to medical device manufacturers before they undertake clinical investigations.
- Pre-Clinical Meeting program pilot to run from November 2018 to March 2019.
- Formal Pre-Clinical Meeting guidance to be published following program pilot.
Canadian medical device regulator Health Canada is preparing a pilot for a new program allowing manufacturers to request meetings with the agency for feedback on proposed clinical investigation protocols and related issues.
According to a new Health Canada notice, the pilot for its Pre-Clinical Meeting program will begin in November 2018 and run until March 2019. The program will establish a formal process whereby medical device companies may request meetings to obtain advice and recommendations from the regulator about their investigational testing protocol designs before submitting Investigational Testing Authorization (ITA) applications for approval.
Following the Pre-Clinical Meeting program’s pilot phase, Health Canada plans to publish new guidance to formalize the process.
Pre-Clinical Meeting pilot eligibility
The Pre-Clinical Meeting program pilot is targeted at medical device manufacturers planning on submitting ITA applications for Class III or Class IV devices, as well as for Class II devices qualifying as novel or disruptive technologies. Eligible companies must also have selected Canadian investigation sites as well as detailed clinical investigation protocols.
Manufacturers should submit cover letters expressing interest in pilot participation; such letters should include the following details:
- Three proposed Health Canada meeting dates and times within the pilot’s November 2018-March 2019 timeframe;
- Location of manufacturer’s investigational site;
- Synopsis of proposed clinical study;
- List of questions to be raised with Medical Devices Bureau as well as related background information.
Health Canada will notify companies via email whether they will have been selected for the pilot.
“Health Canada expects that this initiative will result in earlier interactions with manufacturers, resulting in more timely and positive regulatory decisions,” states the regulator in its notice.
Related Canadian medical device regulatory resources from Emergo:
- Health Canada Medical Device License (MDL) registration consulting
- Medical Device Single Audit Program (MDSAP) training
- CMDCAS, MDSAP and Health Canada ISO 13485 QMS compliance support
- Whitepaper: Preparing a Canadian MDL application
- Regulatory process chart: Health Canada regulatory approval pathways