CFDA Sees Increase in Adverse Event Reports
China’s Food and Drug Administration received more than 350,000 medical device adverse event reports in 2016, an increase of 10 percent on the previous year.
In its annual medical device adverse event report, the agency said the quality of the reporting has also increased, allowing it to better assess postmarket risk.
The majority of adverse events were reported by medical institutions. In 2016, device manufacturers reported only 1.9 percent of adverse event reports, medical device companies reported 13.9 percent, and 0.05 percent were reported by individuals.
Roughly 41.5 percent of the device AE reports filed involved Class III medical devices, 42.2 percent involved Class II medical devices and 11 percent involved medical equipment.
Of the 350,000 adverse events reported, 52,331 (14.8 percent) resulted in serious injuries, and 181 were fatal.