Case Study 23: Registration of a Class II Medical Device in Canada and USA

Company Situation

The Client had developed a combination device intended for temporary protection and restoration of bladder cavity that used in combination with hyaluronic acid. The Client had already registered the product in Europe and was seeking a partner for global expansion. Starting with the product registration with US FDA and Health Canada. Client was seeking a partner for local representation, help markets’ access and expansion in US and Canada.

GRP Solution

GRP provided regulatory strategy for combination products’ registration in USA and Canada. Further, GRP recommended a regulatory strategy based on the device classification and requirements for registration in Canada and USA., GRP also extended its support by becoming local agent of the client in USA and Canada.

Want to be updated on the Latest Regulatory Information

Follow GRP on Social Media !