Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say.
To get around the trial requirement, devicemakers must submit data from a trial of an older device to which the newer one is being compared. Two devices may be deemed equivalent if the differences in their operating principles, structures, materials, production processes, safety evaluation, applicable national or industry standards and intended use are so minor as to not affect the device’s safety or efficacy, a new guideline released by the China Food and Drug Administration says.
The guideline also exempts so-called catalog products from clinical trials. Evidence shows they are equivalent to items on the CFDA’s formal list of devices exempted from clinical studies.
For most devices requiring clinical trials, the manufacturers may submit data from overseas studies as long as the trial design meets Chinese standards for sample size, control group selection and end point. The data must also show that the device is equally effective across different ethnic groups. That does not apply to certain Class III devices, which require Chinese trial data, the CFDA says.
For lower-risk products, literature reviews conducted in major scientific databases and empirical data collected from clinical use of the device, including adverse event reports, may be acceptable, the agency adds.