By King & Wood Mallesons’ Compliance Group

On March 7th, 2014, the State Council issued the Regulation on the Supervision and Administration of Medical Devices (“Regulation”). On July 30th, 2014, China Food and Drug Administration issued the Measures for the Management, Supervision and Administration over Retail of Medical Devices (“Measure”). On December 12th, 2014, China Food and Drug Administration issued the Standards for Quality Control of Medical Devices (“Standard”). The series of regulatory actions demonstrates China’s efforts to strengthen administration of manufacturers and retailers of medical devices and equipment.
Continue Reading Medical Devices production enterprises are facing higher supervision