In order to strengthen the supervision and management of medical devices, improve enterprises' quality management level and ensure the safety and effectiveness of medical devices, China Food and Drug Administration (CFDA) recently formulated and issued the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for Sterile Medical Devices (No. 101 Announcement of 2015), the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices (No. 102 Announcement of 2015), and the Announcement on Promulgation of Good Manufacturing Practice for Medical Devices Appendix for In Vitro Diagnosis Reagents (No. 103 Announcement of 2015) in accordance with the Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650) and the Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7).

The three Appendixes, which give special requirements to the Good Manufacturing Practice of sterile medical devices, implantable medical devices and in vitro diagnosis reagents, will come into effect as of October 1, 2015.