The China CMDE issued guideline for real-world research design and statistical analysis of medical devices

Document Number:No. 3, 2024

Date Issued:  January 15, 2024

To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics).

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