China’s Food and Drug Administration (CFDA) recently released guidelines for the clinical evaluation of Class II and Class III medical devices. The guidelines also outline the documentation required by the CFDA.
A clinical trial waiver may be granted if the device is shown to be equivalent to other products on the CFDA’s list of devices exempt from clinical studies. Clinical trials are also not necessary if a device is determined to be basically equivalent to a product already on the market in China. This means that any differences in the two devices’ materials, safety, production processes, intended use, structure, and operation must not have any appreciable impact on device efficacy and safety. Also, clinical study and usage data from the currently marketed device can be submitted for the “new” device.
For devices that do require clinical trials, the CFDA in some cases may still accept data from studies conducted overseas. In these cases, the trial design should meet Chinese standards. Certain high-risk devices – such as implantable pacemakers, intravascular stents, and artificial organs – will require local clinical trials to be conducted in China for product registration. For some lower risk devices, data collected from use of the device and literature reviews may be sufficient.