Currently in China, except the in vitro diagnostic reagents (IVDD) used for blood screening and adopting radioisotope labeling, other IVDD need to be managed as medical device (MD). IVDD is divided into three management categories according to their risk level. There are some special requirements during the IVDD registration in addition to the general regulations of medical device.
During the SFDA registration, class 2 and 3 IVDDs are required to conduct clinical trial in China. Osmunda has rich clinical resource and experience and would provide you with best all-round service.