China medical device real-world evidence is increasingly important for supplementing clinical evaluations and expediting the approval of urgently needed imported medical devices into China.
Significant strides have been made by the Center for Medical Device Evaluation (CMDE) at the National Medical Products Administration (NMPA) in China since 2018 in the realm of Real-World Data (RWD) research for medical devices. The CMDE, responsible for medical device technical evaluations, has shown positive progress in formulating technical specifications for RWD applications and establishing effective working mechanisms.
Efforts began in April 2018 with the issuance of interim regulations governing urgently needed imported medical devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone. This laid the foundation for the application of clinical data obtained from real-world usage for product registration. The subsequent development of a preliminary plan for data collection and methodological research on RWD application in clinical evaluations marked key milestones.
The pilot phase witnessed the inclusion of imported medical devices into real-world data application trials, with the glaucoma drainage tube being the first product to gain approval in March 2020. The article emphasizes the role of real-world evidence (RWE) as a crucial supplement to existing clinical evidence in evaluating product safety and effectiveness.
As the pilot program progressed, the CMDE actively explored effective working mechanisms. In April 2022, joint efforts with the Hainan Provincial Medical Products Administration led to the publication of communication and exchange procedures, establishing a pre-communication platform for clinical real-world data application. Notably, the Center’s involvement in international initiatives, such as the International Medical Device Regulators Forum (IMDRF), contributed to the inclusion of RWD in international harmonized documents, marking a global push for the scientific and standardized application of RWD in medical device clinical evaluations.
The integration of RWD application into the broader system of clinical evaluation guiding principles led to the Technical Guidelines for the Clinical Evaluation of Medical Devices and related documents emphasizing the inclusion of real-world data sources, recognizing the significance of RWD obtained from diverse and extensive user populations.
Efforts in regulatory scientific research on RWD applications continue, with the China Drug Regulatory Science Action Plan serving as a key driver. Ongoing and future research projects aim to further refine the methodological framework for RWD application, contributing to the development of a robust system supporting the use of real-world evidence in medical device regulatory decision-making. The potential and value of RWE in driving scientific, efficient, and precise decision-making, is injecting new vitality into China’s medical and health industry.
Read the original CMDE article on increasing important of real-world evidence to support medical device authorizations in China in full.
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