Recently, the Office of the State Drug Administration has distributed the Circular on Seeking Comments on the Revision to the Requirements on Some Application Materials for the Renewed Registration of Medical Devices and Others (the "Circular") for public consultation by June 30, 2018.
According to the Circular, "Item 1 through Item 6 listed under 5. Product Analysis Reports within the Validity of the Registration Certificate" in the Appendix V to the Announcement on Issuing Requirements on Application Materials for the Registration of Medical Devices and the Format of Approval Documentation and in the Appendix IV to the Announcement on Issuing Requirements on Application Materials for the Registration of IVD Reagents and the Format of Approval Documentation, are revised to read as "5. Where it is clearly required on the original registration certificate for medical devices to proceed with the work, relevant summary reports accompanied by relevant materials shall be provided". Further, the Circular state that, where clinical trials are conducted in multiple centers for a type of medical devices, the written consent to clinical trials from the ethics committee of the entity leading the clinical program shall be submitted; where clinical trials are not performed in multiple centers, the written consent to clinical trials from the ethics committee in each clinical trial institution shall be submitted.