In December of 2008, SFDA released its first adverse event policy through a regulation titled “Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (interim),” SFDA document [2008] No. 766. The regulation stipulates that the SFDA is responsible for nationwide monitoring of adverse events and re-evaluation activities. The regulation requires that an adverse event reporting procedure must be established within the manufacturers, distributors and medical end users, with dedicated staff responsible for such activities. The regulation also specifies that adverse events that caused death must be reported within five business days. Serious injuries must be reported in 15 days. Within 20 business days after the occurrence of an adverse event, the manufacturer must submit a summary report to the local office of the U.S. Food and Drug Administration. Besides the adverse-event policy, SFDA released a draft for product recall regulation. The draft was released in 2008, and the formal interim regulation is expected to be released this year.
From an initial report published by the China Drug Adverse Event Monitoring Center, which monitors drug and medical device adverse events, the center received more than 41,000 potential adverse event reports for medical devices in 2008, which is three times the number of reported events in 2007. Death was suspected in 37 reports. The dramatic rise in adverse event reporting signals increased awareness of product safety and the expanded reporting channels through the reporting center’s data system. SFDA and the monitoring center will continue to promote and educate the regulatory professionals and the public on adverse event management and reporting. Activities in this area are expected to increase.