China’s highest executive body, the State Council, has passed a significant amendment to the Medical Device Supervision and Administration Regulation (MDR). The MDR, which has not been amended since its original enactment in 2000, is the core piece of legislation governing all aspects of medical device regulation in China, including research and development, approval and registration, manufacturing, importation, distribution, device use in medical institutions, advertising and promotion, post-market surveillance and penalties. This revision to the MDR will become effective on June 1, 2014 and will be followed by revisions to its various implementing rules administered by the China Food and Drug Administration and provincial food and drug regulatory authorities.  Although comment deadlines on the proposed implementing rules were originally set for April 30, 2014, the deadline has been extended to May 31, 2014.  All medical device companies doing business in China should carefully review these changes and determine how they will apply to their operations.