China Issues Fresh Guidelines Urging Devicemakers to Utilize AER Systems

The China Food and Drug Administration plans to step up its tracking of medical device adverse events in hospitals, and is asking high-risk and Class III devicemakers to refer to a 2011 guideline on electronic monitoring to facilitate submission of incident reports. CFDA officials announced the effort, which will be rolled out through 2015, at the recent China International Medical Device Regulatory Forum in Xi’An, according to Seth Goldenberg, a global medical research scientist at NAMSA, a regulatory and compliance research group.
International Medical Device Regulatory Monitor