Case Study 2: Regulatory Strategy, Clinical Trials and Registration of Class III Dermal Filler in China

Company Situation

The Client is a manufacturer of innovator devices based on laser, ultrasound, light and radiofrequency for aesthetics and surgical markets. Client has devices already registered in several key global markets and was seeking a partner to take its dermal filler device, classified as Class III in EU to China. Since the product had to be approved in China for surgeries, it required a holistic strategy right from identifying suitability to Chinese population, create necessary clinical data as per NMPA regulations and develop a unique marketing differentiator.

GRP Solution

GRP has significant experience in planning, conducting clinical trials in China, as well as sound understanding of potential of devices in Chinese market. GRP identified that since the device is a dermal filler classified as Class III, it is subject to local testing and local clinical trials. GRP provided comprehensive strategic inputs to Client to enable its successful approval in China using following methods.

Click on ' learn more' for the full case study