China Continues To Explore Real-World Evidence To Enhance Clinical Evaluation

In a recent conference held from October 31 to November 1, the National Medical Products Administration’s Medical Device Technical Evaluation Center (Center) showcased groundbreaking advancements in leveraging real-world evidence for clinical assessments of medical devices. The Second Boao International Conference on Real-World Medical Device Research, themed “International Real-World Data Research and Scientific Development of Medical Device Regulation,” provided a platform for discussions on crucial topics within the field.

Since 2018, the Center has pioneered the use of real-world evidence in the medical device domain, paving the way for the approval and market entry of numerous urgently needed imported medical devices. Notably, the Center’s leadership in the development of the “Post-Market Clinical Follow-up of Medical Devices” outcomes document at the International Medical Device Regulators Forum (IMDRF) in May 2021 has established it as a trailblazer in incorporating real-world data into international coordination efforts.

The Center’s efforts have resulted in the inclusion of 13 medical device varieties in the pilot application of real-world data, leading to the successful market approval of nine products within seven varieties. Looking ahead, the Center aims to normalize the use of real-world data applications for medical devices, with nine varieties already formally entering the pre-communication channel as of April this year.

This initiative aligns with the Center’s broader vision of creating a modernized evaluation system (version 2.0) to actively promote real-world data research. These advancements will significantly enhance the role of real-world evidence in the evaluation of medical devices, particularly for high-risk and new products.

Stay informed with the latest healthcare updates from BradyKnows Medical (www.bradyknowsmedical.com). BradyKnows Medical continues to monitor and support these groundbreaking developments, recognizing the transformative impact they hold for the future of medical device evaluations.