On May 9, 2018, the government of Hainan Province China issued the notice and guidance on the importation and use of none CFDA registered but clinically urgent-need medical devices in Hannan Boao Lecheng International Medical Tourism Pilot Zone. This guidance provides some details on the responsibilities of hospitals/medical institute, manufacturers and government agencies, and a process for supervision and regulation. Hainan Boao Lecheng International Medical Tourism Pilot Zone is a world-leading green city project which integrates medical services, wellness, pharmaceuticals, scientific research, rehabilitation, senior care, and tourism in an area dedicated to energy conservation and environmental protection. It is located at the eastern side of Hainan Province (an island located off the coast of Southern China). The project goal is for Hainan to become a world-class medical and wellness destination before the end of this decade.