Abstract: Since the releasing of Order 650 in 2014, China Food and Drug Administration (CFDA) organized professionals to intensively formulate and revise regulations based on the original medical device supervision regulations system. Up to now, China medical device supervision new regulation system has been formed basically and has profound active implications on the whole medical device industry. The article analyzed the change of requirements of medical device supervision new regulation system from manufacture's point of view and tried to provide some simple suggestions of adapting them.