Product Safety Regulatory Regime for Medical Devices 

Classification of medical devices 

Under the PRC legal regime, “medical devices” refers to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or relevant articles including necessary computer software that are directly or indirectly used for the diagnosis, prevention, monitoring, treatment or relief of diseases or injury, the functional compensation of injuries, the inspection, substitution, adjustment or support of physiological structures or physiological processes, the control of pregnancy or the support or maintenance of life. Unlike a pharmaceutical, the utility of medical devices is mainly achieved by physical or other means rather than pharmacological, immunological or metabolic means, or where the latter means only act as auxiliary functions. “Medical instrument” is not a legally defined term under the PRC laws. Generally, medical instruments would be interpreted as being the same as medical devices.