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

Abstract

Introduction: The rapid growth of the medical device industry has driven the evolution of regulatory guidance on medical device clinical evaluation (MDCE) of the China National Medical Products Administration (NMPA), which consequently influences pre-market and post-approval clinical evaluation (CE) strategies.

Areas covered: We aimed to investigate the 3-stage evolution of NMPA regulatory guidance on MDCE (1. The era before specific CE guidance, 2. 2015 CE Guidance, and 3. 2021 CE Guidance Series), analyze the gaps between each stage, and assess the evolution's impact on pre-market and post-approval CE strategies.

Expert opinion: The fundamental principles of the NMPA 2021 CE Guidance Series were transformed from the 2019 International Medical Device Regulatory Forum documents. Compared with the 2015 guidance, the 2021 CE Guidance Series further clarifies the CE definition by emphasizing the ongoing activity of CE through an entire product lifecycle and the use of scientifically sound methods for CE and narrows the pre-market CE pathways into the equivalent device and clinical trial pathways. The 2021 CE Guidance Series simplifies the process for selecting the pre-market CE strategy but does not specify post-approval CE update cadency and general requirements for post-market clinical follow-up.