Compliance Discussion Under the Current Medical Device Regulatory System—Medical Device Clinical Evaluation
By distinguishing the concepts of clinical data,clinical evidence,clinical trial and clinical evaluation,introducing regulatory requirements,sorting out the clinical evaluation requirements of various medical devices in the process of registration/domestic medical device filing.Among them,the first class medical devices(including in vitro diagnostic reagents)do not need clinical evaluation,but it needs to be determined that they meet the requirements of first class medical devices based on the actual use and characteristics of medical devices.There are three clinical safety and efficacy evaluation pathways for the second and third categories(excluding in vitro diagnostic reagents),including:① comparative analysis based on the"Catalogue of Medical Devices Exempted from Clinical Evaluation";② Evaluation method based on evidence of safety and effectiveness of medical devices already on the market;③ Clinical trial method.The second and third types of in vitro diagnostic reagents should undergo clinical trials in accordance with the requirements of the"Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents".Clinical evaluation data for medical device products should be formed in accordance with regulatory requirements.