July 13, 2018

The Hainan Government has issued “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”, which shall be applicable for the importation and approval of medical equipment urgently needed in the clinical setting. In early June, the Hainan FDA branch has released a similar guideline illustrating the qualifications of medical institutions, and procedures on how to apply for emergency medical devices.           

In the recent guideline, it was clearly mentioned that the medical institution shall provide relevant foreign clinical data which includes the clinical use of the products, an overview of adverse events associated with its overseas use, a summary of the clinical research and the risk assessment of the device across racial differences. Moreover, the medical institution shall assess the registration condition of the similar products in China, and shall justify the necessity and urgency of the products being applied.

Reference: Official press