To standardize and guide the application of real-world data in the clinical evaluations of medical devices, according to the work arrangements of China Action Plan on Scientific Drug Administration of the National Medical Products Administration, the National Medical Products Administration has organized the formulation of the Technical Guidelines for Using Real-World Data for the Clinical Evaluations of Medical Devices (for Trial) and hereby issues it.
Attachment: Technical Guidelines for Using Real-World Data for the Clinical Evaluations of Medical Devices (for Trial)
Attachment: Technical Guidelines for Using Real-World Data for the Clinical Evaluations of Medical Devices (for Trial)
National Medical Products Administration
November 24, 2020
November 24, 2020