The clinical trials of medical devices are divided into clinical testing and clinical verification.
Clinical testing refers to verifying if factors such as the theoretical principle,basic structure and performance of the medical device are able to guarantee its operating safety and effectiveness,by means of clinical application.Clinical testing is applicable to those medical devices that have not yet been made availbale on the market,or whose safety and effectiveness are subject to verification.
Clinical verification refers to ensuring that test products and the products already on the market are virtually the same in terms of their basic structure,performance,safety and effectiveness.Clinical verification is applicable to medical devices whose identical products or similar kinds have already benn launched on the market,or whose safety and effectiveness need to be further verified.
Clinical trials are mandatory for the registration of Class III medical devices;such trials are usually required for the registration of Class II medical device,but are not needed for the registration of Class I medical device.
The clinical trials of medical devices shall be conducted in at least two medical institutions.Clinical trials of Class III IVDs(in vitro diagnostics) must be made in no less than three medical institutions at the provincial level,and Class II IVDs must be trialed in no less than two medical institutions at the same level.The minimum sample size of a clinical trial for a Class III IVD is 1,000,and 200 for a Class II IVD.