Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies

Su, G; Deng, DY

Su, G (通讯作者)，Medtron China, Dept Clin Res & Med Sci, 22nd Floor, Block D, Pl Tower, 9, Guanghua Rd, Beijing 100020, Peoples R China.

EXPERT REVIEW OF MEDICAL DEVICES, 2023; 20 (3): 167

Abstract

IntroductionThe rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDC......

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