As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices, to address the need for clinical treatment of severely life-threatening diseases, and speed up the review & approval of related medical devices, NMPA organized the formulation of and released on December 20, 2019 theGuidelines for Conditional Approval for Marketing of Medical Devices.