In order to optimize the evaluation and approval procedures for drugs and medical devices, and improve evaluation and approval efficiency, China Food and Drug Administration (CFDA) recently issued The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Drugs (CFDA Order No. 31), and The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Medical Devices (CFDA Order No. 32), to adjust CFDA's administrative approval procedures for the approval of high risk clinical trials, the approval of re-registration and registration renewal, and the approval of registration alteration of drugs and medical devices. CFDA's administrative approval right for the above procedures for medical device has been transferred to Center for Medical device Evaluation of CFDA, which means for the above procedure, the approval process, would be quicken by one month.
For more information of this Order, please contact with us.