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【CODEX】Instructions on the Application of Electronic Regulated Product Submission (eRPS) System
Date:2021-11-04
¥569.40
Download
【CODEX】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.



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买


【CODEX】Instructions on the Application of Electronic Regulated Product Submission (eRPS) System
Date:2021-11-04
¥569.40
Download
【CODEX】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.



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.


      以上是免费内容,查看更多可立即购买


Our Advantages
Sixteen years of translation experience in medical and intellectual property fields
Sixteen years of translation experience in medical and intellectual property fields
Since the establishment, CODEX has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
Professional and Elite Team
Professional and Elite Team
The translation team consists of graduates returned from abroad, post-graduate students from the most prestigious universities, professional native-speaking translators and consultants in the medical industry.
Authoritative Quality Certification
Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO9001:2015 and ISO17100:2015 Quality Management System Certification.
Strict Control Process
Strict Control Process
Codex has established a perfect translation quality assurance system and systematic operation process, strictly adopts the working procedure of  “firstly translation, secondly modification, thirdly proofreading and fourthly review”.
Excellent Staff Quality
Excellent Staff Quality
Being strictly examined and selected, every one of us is characterized with a strong sense of responsibility and proficiency in medical translation , and we strictly follow the confidential system.
Client Support
Client Support
“Pursue Excellence, Strive for Perfection”. Serve you with quality and confidentiality .
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Beijing CODEX Translation Co.,LTD

400-136-8786

We Are Here For You 24/7
Who We Are
As one of the few medical translation suppliers in China that have been certified by ISO17100: 2015, we have been providing life sciences translation services, localization services and intellectual property translation services since our founding 16 years ago.
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