Now, Chinese regulations on medical devices are undergoing earthshaking changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the pasted three decades. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices to try to completely change such imperfect status. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Measures for the Supervision and Administration of Medical Device Production”, “Measures for the Supervision and Administration of Medical Device Distribution” and “Measures for the Administration of IVD registration” on July 30, 2014 respectively, and they will come into force as October 1, 2014. The radical change of regulations on medical devices, especially for the latest “Measures for the Administration of Medical Device Registration” will bring overseas and multinational medical device manufacturers the maximum challenges and opportunities.