Case Study 3: Regulatory Strategy for Registration of a Class I Wearable Pain Relief Device and Software in Japan

Company Situation

Client is a global CRO that was in process of registering a wearable class I pain relief device along with a mobile app in global markets. The Client, however, was not clear with the strategy for classification and registration of device along with the mobile app/software in Japan due to novel nature of the device and limited experience in Japanese market.

GRP Solution

GRP’s experts are experienced in registering medical devices, software as device and combination thereof in Japan. GRP used this experience to evaluate the device’ material information, evaluate and assess related information and develop strategy for the Japan market. The Client received a well-defined strategy that was used to enable additional investment decisions to expand device’ commercial scope.

Please click on ' Learn More' for the full Case study