In order to intensify the monitoring and re-evaluation of medical device adverse event, in accordance with Regulations for Supervision and Administration of Medical Devices, the Ministry of Health and the State Food and Drug Administration (SFDA) formulated Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (interim) which apply to medical device manufacturing and distributing enterprises, medical device users, technical institutions for medical device adverse event monitoring, food and drug regulatory departments and other relevant authorities. The Requirements defines the main responsibilities of medical device adverse event monitoring and re-evaluation nationwide and within each provinces (autonomous regions, cities) and relevant technical works on nationwide medical device adverse event monitoring and re-evaluation. The Requirements, comprising five chapters and 43 articles, came into effect as of December 30, 2008.