Sep 20, 2012

Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow unannounced inspections of medical device manufacturers.

The SFDA’s Working Procedures for Unannounced Inspection of Medical Device Manufacturers provides a legal basis for Chinese regulators to conduct surprise inspections of device firms to determine compliance with current requirements. According to law firm CMS Cameron McKenna, if officials find any violations during such inspections, they may turn inspections over to local SFDA investigators, which in turn could result in possible sanctions. However, a manufacturer may appeal, explain or immediately correct a found violation in order to reduce the likelihood of further investigation and penalties.

 A similar SFDA inspection regimen already exists for pharmaceutical products in China. Although the prospect of surprise inspections may present challenges for manufacturers, the depth and breadth of the Chinese medical device market should continue to warrant interest from foreign firms.

Emergo Group will continue to monitor the situation and provide further details as we get them.


  • Stewart Eisenhart