Instructions on the Application of
Electronic Regulated Product Submission (eRPS) System
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  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.
I. Basic Principles and Scopes
(I) Basic Principles
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.
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