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Medical Devices 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, materi- als 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 sup- port of physiological structures or physiological processes, the control of pregnancy or the sup- port or maintenance of life. Unlike a pharma- ceutical, 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. Gener- ally, medical instruments would be interpreted as being the same as medical devices.
Activities relating to medical devices have been strictly regulated in the PRC, and the regulations that apply to a medical device in the PRC depend on how that medical device is classified. Medical devices are categorised into three classes according to their risk levels. The National Medical Products Administration (NMPA) determines a medical device’s risk level according to its intended purposes, structural features, the form of use, whether it is in con- tact with or has access to the human body, and other factors. In general, Class I medical devices refer to those that have a low degree of risk and whose safety and effectiveness can be ensured through routine administration, and therefore they are merely subject to a record-filing admin- istration under the supervision of the NMPA and its local counterparts; Class II medical devices refer to those with a medium degree of risk; and Class III medical devices refer to those with the highest risk level, the safety and effectiveness of which need to be ensured by strict control and regulation, and which therefore are subject to registration administration under the supervision of the NMPA. The NMPA has issued the Rules for Medical Device Classification and the Cata-logue of Medical Device Classification to guide this classification of medical devices.
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