The General Office of the State Drug Administration ("SDA") has recently issued the Technical Guide to the Electronic Submission of Applications for the Registration of Medical Devices (for Trial Implementation) (Draft for Comment) (the "Draft for Comment") for public consultation by June 22, 2018.
The Draft for Comment provides for general requirements concerning the submission of electronic registration application materials by registration applicants or registrants, covering the sphere of application for the electronic submission of applications for registering medical devices, requirements on the computer system, requirements on user security, requirements on the format of electronically submitted application materials, operation procedures of the informatization system used to electronically submit applications for registering medical devices, etc. According to the Draft for Comment, the electronic submission regime shall apply to applications for the first-time registration, applications for the renewed registration, applications for changes to registered items and applications for changes to licensed items, for Class III domestic medical devices and Class II and Class III imported medical devices, and applications for the examination and approval of clinical trials conducted for Class III high-risk medical devices.