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June 30, 2016, Inside Medical Devices
On June 7, 2016, the China Food and Drug Administration (“CFDA”) released the Notice on Regulating Distribution Activities in Medical Device Circulation (“Notice”). The Notice requires that distributors of Class II and III devices assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of ...
June 9, 2015, Covington Alert
February 14, 2014, Inside Medical Devices
The China Food and Drug Administration (CFDA) issued a proposed Rule on Good Supply Practices for Medical Devices on December 26, 2013 (Proposed GSP Rule). The comment period closed on January 20, 2014. Good Supply Practices (GSP) refer to a set of standards for quality management of the distribution process for drugs or medical devices. … Continue Reading