Your feedback counts! China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers must follow. To address the technical requirements during the application and further guide the registration review of more…
Your feedback counts! China NMPA technical review guidance documents tend to be more prescriptive. Once issued, all manufacturers must follow. To address the technical requirements during the application and further guide the registration review of CT Imaging Assisted Pulmonary Nodule Detection Software, more…
On December 28, a kick-off meeting for the fast track pilot drugs and medical devices was held in Beijing. At the meeting, Hainan fast track pilot program officially kicked off the first batch of drugs and the second batch of medical devices, more…
“The designated medical institutions in the region can use medical devices that are urgently needed for clinical use, and have been purchased and used by public hospitals in Hong Kong and Macao, and have advanced clinical applications, which can be approved by the Guangdong Provincial Government”, more…
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostic (IVD) (draft)” for comments on November 25, 2020. Feedback needs to be submitted by December 15, 2020. more…
On December 18, 2020, NMPA granted Innovative Approval to the Vertebral Artery Rapamycin Targeted Eluting Stent System produced by Microport. The single-sided grooving drug-coated stent of this product is designed to enhance targeted drug release and improve the efficiency of drug therapy. more…
