Fasken was retained by a major medical device manufacturer to assist with various aspects relating to a stop sale and device re-classification by Health Canada of one of its most important medical device licences (marketing authorization).
The objective was to create a regulatory action plan to ensure that the device could continue to be commercialized in Canada and the company could avoid the stop-sale without jeopardizing its good relationship with the regulators.
As a result of Fasken’s advocacy and strategic initiatives, Health Canada agreed that the company could continue commercializing the device while it seeks a new, higher class licence for its product.
Fasken team was composed of Mathieu Gagné, Jean-Raphaël Champagne and Dara Jospé.
