The State Food and Drug Administration (SFDA) formulated Medical Device Quality Management System Detailed Rules for Sterile Medical Devices (interim), Medical Device Quality Management System Inspection Standards for Sterile Medical Devices (interim), Medical Device Quality Management System Detailed Rules for Implantable Medical Devices (interim) and Medical Device Quality Management System Inspection Standards for Implantable Medical Device (interim) and recently issued notices on relevant requirements, for the purposes of enforcing Quality Management System Regulations for Medical Devices (interim), standardizing the production quality management systems and the supervision and inspection of sterile medical devices and implantable medical device