The Medical Device Business Unit is established by merging the entire team from the Registration Department of China's most influential medical device organization,China Association of Medical Device Industry (CAMDI) with the medical device clinical research team of DMS. Based on extensive project experiences and in-depth collaboration with industry experts & consultant teams, we have a better understanding and interpretation of Chinese regulations.
GCP has provided outstanding regulatory affair services and obtained market licenses for hundreds of domestic & foreign clients. In order to meet the demand of medical device exports, we also provide consulting services; help clients apply for medical device export certificates, and /or act as a FDA registration agent.
In 2010, GCP was appointed as the exclusive clinical research service provider by CAMDI.
Medical Device Registration
|Drafting Product Standard|