As the fundamental standard for the safety of medical devices,IEC 60601-1 played an active role in the regulation and safety use of medical devices in China.IEC 60601-1 3rd edition will come into effect in Europe and some developing countries in June 2012.Based on the primary differences of the 2nd edition and 3rd edition of this standard,and taking into account of the status quo of the regulatory system and manufactures of medical devices,this paper points out the possible problems in the implementation of IEC 60601-1 in China and proposes perspectives and measures to address the problems. <<