The State Council decided to suspend implementation of item 2, article 11 of Regulations for the Supervision and Administration of Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, as a move to support Hainan’s international medical tourism industries.
According to the decision, if there is an urgent need in the pilot zone for certain medical devices not legitimately available in China, the Hainan provincial government can authorize the imports but those devices must be used in designated hospitals.
The State Council urges the State Drug Administration, Hainan provincial government and other relative departments to stipulate specific regulations on approval conditions and processes for importing medical devices.