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.
The report breaks down the type of medical devices by “passive” and “active” devices. The top 10 adverse events reported involved passive devices such as disposable infusion sets, disposable sterile syringes, intrauterine devices, intravenous needles, contact lenses, thermometers, catheter bags, medical tape, infusion needles and catheters. These devices accounted for over 38 percent of the reports.
The top 10 active devices on the list were patient monitors, infusion pumps and syringes, electronic sphygmomanometers, electrocardiograms, hemodialysis machines, ventilators, blood glucose meters, infant incubators, electronic thermometers and microwave therapy machines. The devices accounted for 8.79 percent of the AE reports.
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language and culture) should be taken into account. Order your copy today.