China’s Food and Drug Administration announced that device sponsors submitting clinical trial authorizations at the provincial and local level will no longer need to await approval before beginning the trials.
This means that once sponsors submit documentation to provincial FDAs, they can begin trials immediately. Applicants should file separately for each clinical site, the agency said.
Part of the reason for the switch is that China is implementing new medical device regulations to streamline the clinical trials process. The regulatory authority has reclassified many devices and exempted some from clinical trials.