The CNDA Releases Fourth Batch of Medical Devices Exempt from Clinical Trials

Last month, the China National Drug Administration (CNDA), formerly known as the China Food and Drug Administration (CFDA), released a fourth batch of Class II and III medical devices that may be exempted from the requirement to conduct local clinical studies to obtain product approval. The Class II products include neuro and cardio surgical instruments, medical infrared cameras, anesthesia laryngoscopes, extracorporeal circulation continuous blood gas monitoring systems, passive hemostats, ophthalmic instruments, obstetrics, and gynecology instruments. The Class III products include hemostatic clips, contrast balloons, vena cava filter recovery devices, cardiopulmonary bypass system blood filters, and hemodialysis blood flow monitoring systems.

Since 2014, there have been a total of 1,466 medical devices and in vitro diagnostic products that have been identified that may be exempted from local clinical trials for product registration approval in China.