关键词: font-size:medium, ">智慧监管；医疗器械；远程检查；行政许可

Abstract: Remote inspection of medical device production permission is an important part of intelligent supervision by integrating supervision of regulatory authorities with information technology. Remote inspection can effectively meet the new needs of supervision under the situation of the COVID-19 epidemic prevention and control， and is a development trend of intelligent supervision. As a supplement to on-site inspection mode， remote inspection helps to integrate inspection resources， improve inspection efficiency and promote the formation of a modern intelligent supervision scientific system， but it also has certain limitations.In order to comply with the trend of intelligent supervision empowered by science and technology， Jiangsu province took advantage of information integration of the inspection system to preliminarily explore the mode of remote inspection in production permission for medical device manufacturers through risk assessment and feasibility analysis on inspection items.Combined with this exploration experience， this paper summarizes concerns, risk points and suggestions for remote inspection， with a view to provide reference for scientific decision-making for regulatory authorities.

Key words: font-size:medium, ">Intelligent supervision； Medical device； Remote inspection； Administration permission