NMPA Preparing The Guidelines For Registration Review Of Real-World Study Designs And Statistical Analyses For Medical Devices
2023-10-27
On September 28, 2023, NMPA issued a notice collecting public comments on the Guidelines for Registration Review of Real-World Study Designs and Statistical Analyses for Medical Devices. This draft for public comments covers sections on scope of application, types of real-world research and their application situations, real-world research project design considerations, and statistical analysis of real-world research. With the continuous improvement of regulations and standards, as well as the continuous development of medical technology, the relevant contents of this guideline will be adjusted in due course.
In China, real world data cannot be used as sole clinical evidence at present; however, it can be used to support product registration as a supplement to existing evidence.
Hainan Medical Tourism Pilot Zone is the first place in the country to carry out clinical real-world studies, which provide a “fast track” for the accelerated entry of international innovative medical devices into the China market.
Surgeons involved in RWS permitted from different hospitals in China
Prefer to recruiting local patients from Hainan, convenient for follow up
Shorter follow-up is possible to shorten registration timeline
HGRAC (Human Genetic Resource Administration of China) is required for overseas manufacturers
China RWE can be used to support EU PMCF, FDA PMA etc.
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