June 12, 2018
At the end of May, the China National Drug Administration (CNDA) has issued the "Technical Guidance for Electronic Submission of Medical Device Registration (Trial) (Draft) " (hereinafter referred to as the "Guidance") and sought for public opinion.
The purpose of this guidance document is to guide the applicants on how to use the Electronic Regulated Product Submission (eRPS) system, which can be found in the CMDE website. In eRPS system, the applicant can prepare, classify, submit and preview the registration documents in electronic format. At the same time, the applicant can manage their electronic registration applications in this system.
The content of the guidance includes the application scope of electronic registration of medical device registration, the operation system requirements of computer, the user security requirements, the requirements of the electronic registration application data format, eRPS system operation flow, among others. Moreover, the guidance has further discussed the table of contents of the submission documents of medical device and IVD in the attachment.
The scope of electronic registration application include the following:
1. The initial registration applications for Class III domestic medical device and Class II/ Class III imported medical devices;
2. The renewal applications for Class III domestic medical device and Class II/ Class III imported medical devices;
3. The change application of registration matters and licensing matters for Class III domestic medical device and Class II/ Class III imported medical devices; and
4. The clinical trial application for Class III high-risk medical devices.
The eRPS system link: https://126.96.36.199