Advising Japan based medical device manufacturer to enter new medical device in Canada

Fasken Martineau was retained to assist a Japanese based medical device manufacturer with Canadian market entry of new Class III medical device including product license analysis and classification. As a result of Fasken Martineau’s services, the medical device obtained Health Canada approval in an expeditious manner, which allowed the client to launch its first product in Canada. In addition, Fasken Martineau also assisted with the implementation of an innovative manufacturing and distribution strategy as well as with internal compliance procedures. Various initiatives were also made to optimize access to these products in the hospital sector for all of Canada. Fasken Martineau also advised on restrictions to promotion and sale device.