China Issues Fresh Guidelines Urging Device Makers to Utilize AER Systems

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 Goldberg, a global medical research scientist at NAMSA, a regulatory and compliance research group.  Roughly 900 medical device-related adverse events were reported in China last year, Goldberg says.  Considering that there were more than 14,000 devices registered in China at the end of 2010, that’s a “very low reporting rate,” he tells IMDRM.

“They [CFDA] need to capture more adverse events in China, as right now there is major underreporting,” Goldberg says.  An Oct. 8 “working procedure” calls for the establishment of sentinel surveillance and early-risk warning systems and says monitoring organizations at all levels should strengthen data mining, signal detection and risk-assessment capabilities to ensure early reporting and control of adverse events.  Class III device makers should use the National Medical Adverse Event Monitoring Platform ( to report potential adverse events.

The procedure references two previous documents on adverse event reporting, says Daniel Huang, a quality systems and regulatory affairs officer at consulting firm Celestica — the 2008 regulations on adverse event monitoring and reevaluation and the guideline on an adverse event electronic monitoring system.  Huang says the reporting push doesn’t signify a “big change” in current policy, but underscores the CFDA’s desire to boost reporting of device adverse events. Last year, the agency proposed updates to good clinical practice requirements for medical technology, including details on steps ethic committees should take in following up on and reporting adverse events.

REFERENCE:  FDA News; International Medical Device Regulatory Monitor; November 2013, Vol. 21, No. 11, (IMDRM, October 2012). — Nick Otto

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