“IVD reagent” as mentioned in the Provisions on Registration of IVD Reagents refers to any IVD reagent product that is regulated as a medical device, which is a reagent, kit, calibrator or control material, whether used alone or in combination with an instrument, apparatus, device or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, for the purpose of providing information in the process of prediction, prevention, diagnosis, treatment monitoring or prognosis observation of a disease, or health status evaluation.

IVD reagents used for blood screening and those labeled with radionuclides that are regulated as drugs do not fall under the Provisions on Registration of IVD Reagents.

IVD reagents are divided into Class I, II and III, taking into account their risk levels, ranging from low to high.