May 9, 2018
The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and application process among others.
The selected health institutions in the tourism area may use the imported drugs and medical devices for diagnosis or treatment of specific patient groups, and at the same time, the data generated from the clinical trial may be used for China Medical Device Registration.