医疗器械电子注册申报规范的实施对策研究

目的:针对医疗器械注册电子申报信息化(eRPS)系统实施中存在的问题,提出构建我国医疗器械注册管理改革和审评审批创新对策.方法:分析医疗器械实施eRPS的国际背景,对比eRPS目录与我国现行法规要求间的对应关系,从网页版和客户端版的不同登录方式阐述eRPS前端功能特点,从eRPS的使用原则、使用步骤、申报流程和使用安全...

Research on the countermeasures of implementing eRPS for medical device registration

Objective:To put forward the innovative countermeasures of constructing management reform,appraisal and approval about medical device registration in China for the existing obstacles in the implementation of electronic regulated product submission(eRPS)of medical device.Methods:This paper analyzed the international background of implementing eRPS for medical devices,and compared the corresponding relationship between the eRPS catalog and the requirements of current regulations,and stated the features of front-end functions of eRPS from the different login methods between the web version and the client version.The eRPS usage specifications was formulated from using principles,using steps,submission procedures,using safety and other aspects of eRPS.And then,the solution of problem was proposed.Results:The implementation of eRPS could reduce the probability of supplement documents after submission,and improve the quality of the registration and submission of medical device.And the enterprise could submit application to the member countries of International Medical Device Regulations Forum(IMDRF)for these corresponding submission documents at the same time and didn’t need readjustment so that the submission efficiency was improved.The ratio of on-line electronic submission and off-line submission with paper material was fast increased from 1.1:1.0 during June and August of 2019 to 6.5:1 in October of 2019.The percentage of on-line submission of the registration application of medical device was 80%of the total amount of registration application.Conclusion:e RPS can provide data support for the full life cycle supervision of medical devices,and can provide efficient path from concept recognition to actual operation for enterprises so as to ensure the successful implementation of the project of the specification of electric registration submission of medical device.