www.fdanews.com/articles/188377-health-canada-to-offer-preclinical-meetings-to-devicemakers
Health Canada to Offer Preclinical Meetings to Devicemakers
September 12, 2018
Health Canada is launching a pilot program to offer preclinical advice to devicemakers on their investigational testing protocols for new products.
The agency hopes the new program — under Health Canada’s Regulatory Review of Drugs and Devices Initiative — will improve the quality of submissions and provide “more timely regulatory decisions.”
Device manufacturers will be able to contribute to the design of the pre-clinical meetings and guidance material, the agency said.
The pilot program will run from November 2018 to March 2019.