On November 25, 2020, CMDE announced its preparation of Technical Guidelines for Overseas Clinical Trial Data Application on IVD (Draft). The overseas clinical data claiming in the guidelines refers to the research data generated during clinical trials of in vitro diagnostic (IVD) more…
NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on US Thanksgiving Day, November 26th, 2020. The first draft for feedback on more…
On October 28, 2020, NMPA granted Innovative Approval to Peripheral Nerve Repair Graft Product produced by Jiangsu Yitong Biotechnology Co. LTD. The composition of the product is a pioneer at home and abroad; The catheter part plays the role of bridge, more…
On November 2, 2020, NMPA intends to allow the following eight applications to be subject to the innovative green pathway review procedure. This innovative pathway will greatly accelerate the registration process and Bradynuoen and help you evaluate the possibilities of your application. more…
