Advising on market entry of a private label medical device

Fasken was engaged by a multinational pharmaceutical company when the company first contemplated Canadian market entry of its medical devices.

The company required advice on the optimal manufacturing and distribution approach for its device to be used by healthcare professionals in the field. Fasken advised on the pre and post-licensure regulatory responsibilities for private label manufacturers, importer and distributors. Fasken also drafted contractual agreements, including legal manufacturing and commercialisation agreements.

Fasken team was composed of Mathieu Gagné, Jean-Raphaël Champagne and Dara Jospé.