As a possible data source of clinical assessment of medical devices, real-world data has attracted increasing attention from regulators and industries with the characteristics including abundant data resources, good extrapolation of research results and availability of long-term clinical outcomes. The National Medical Products Administration (NMPA) initiated the “China Drug Administration Scientific Action Plan” in April 2019, which included the “Methodological Study on the Application of Real-world Data in Clinical Assessment of Medical Devices” into the first batch of research projects to explore the feasibility and methodology in the application of real-world data in regulatory decisions, providing a new solution to the reform of examination and approval system of medical devices and accelerating the marketing of innovative products.
Led by the Department of Medical Device Registration and Department of Medical Device Regulation of NMPA, this project was implemented by the Center for Medical Device Evaluation of NMPA with the cooperation of Sichuan University, Zhejiang University, Peking University, Food and Drug Administration of Hainan, etc. Based on the research achievements of project, we, the Center for Medical Device Evaluation of NMPA, drafted and requested for public comments on Technical Guiding Principles for Application of Real-world Data in Clinical Assessment of Medical Devices (Draft for Comments). We hope that experts, scholars, manufacturers and relevant practitioners in the relevant fields can give us valuable comments and suggestions.
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National Medical Products Administration
Center for Medical Device Evaluation
December 13, 2019
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