Embracing Single-Arm Study Design in the Wake of NMPA's Clinical Evaluation Reforms for Medical Device Innovation
The NMPA CMDE are advancing medical device innovation with reforms focusing on single-arm study designs to enhance clinical evaluations, ensuring devices meet the highest standards of safety and efficacy for end-users.
Read MoreAddressing the Complexities of Single-Arm Clinical Trials in Medical Device Innovation
TX Medical News emphasizes the critical need for careful, evidence-based selection of single-arm clinical trial designs in medical device innovation, ensuring safety and efficacy while addressing the unique challenges of groundbreaking technologies.
Read MoreHangzhou Tangji Medical Technology Pioneers with NMPA-Approved Gastric Bypass Stent System
The NMPA's approval of Hangzhou Tangji Medical Technology's innovative Gastric Bypass Stent System introduces a non-surgical obesity management solution, promising a safer alternative for effective weight loss.
Read MoreGroundbreaking Guidance Released by the NMPA on Real-World Study Design for Medical Devices
The "Guidance on Real-World Study Design and Statistical Analysis for Medical Device Registration Review" issued by the NMPA and CMDE on January 10, 2024, revolutionizes the use of real-world data in China's medical device clinical evaluations, enhancing device safety and efficacy assessments in real-life applications.
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