【CODEX翻译】关于实施医疗器械注册电子申报的公告附件-中英双语

【CODEX翻译】关于实施医疗器械注册电子申报的公告附件

医疗器械注册电子申报信息化系统（eRPS）启用说明

Instructions on the Application of

Electronic Regulated Product Submission (eRPS) System

      为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），国家药品监督管理局（以下简称国家药监局）开展医疗器械注册电子申报信息化系统（eRPS）的建设工作，研究借鉴国际医疗器械注册电子申报经验，实现医疗器械注册申请的电子申报和在线审评。目前，eRPS系统已完成建设和测试工作，具备上线运行条件。按照《国务院关于在线政务服务的若干规定》（中华人民共和国国务院令 第716号），国家药监局逐步推进医疗器械注册政务服务平台建设、安全保障和运营管理，做好从传统的纸质资料提交到电子申报的过渡。

In order to implement the Opinions on Deepening of the Reform of Review and Approval System to Encourage the Innovation of Drugs and Medical Devices (SC [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, the National Medical Products Administration (hereinafter referred to as the NMPA) has carried out the establishment of electronic Regulated Product Submission (eRPS) System for the electronic application for medical device registration, and studied and learned from the experiences of electronic application for international medical device registration, so as to realize the electronic application and online review of the application for medical device registration. At present, the eRPS system has been established and tested, possessing the online operating conditions. According to the Provisions of the State Council on Online Government Services (Decree of the State Council of the People’s Republic of China No. 716), the NMPA has gradually promoted the construction, security and operation management of the government service platform for the registration of medical devices, and made a good transition from the traditional submission of paper dossiers to electronic application.

一、基本原则和范围

I. Basic Principles and Scopes

（一）基本原则

(I) Basic Principles

      1.信息保密。为提高电子申报资料的安全性，eRPS系统配套使用数字认证证书（Certificate Authority，CA）进行登录、签章、上传、查询、浏览等功能，防止申报资料、审评审批等信息泄露。

1. Information Confidentiality. In order to improve the security of electronic application dossiers, the eRPS system uses the Certificate Authority (CA) for login, signature, upload, query, browse, etc. to prevent the disclosure of information such as application dossiers, review and approval.