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IVD (In Vitro Diagnostic) in China

"IVD" is the English abbreviation for in vitro diagnostic products. In the international arena, IVD, as a sole branch of medical devices, has its unique definition and regulatory system, especially in the United States Food and Drug Administration (FDA) and the European Union (EC). In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Whereas it is different in China, that IVD is not distinguished and defined solely. In other words, there is no concept of IVD existing in China. In China, the normal contained products of IVD recognized internationally are broken up and subordinated to medical devices (MD), in vitro diagnostic reagents (IVD Reagents), as well as drugs respectively.

In China, except two kinds of in vitro diagnostic reagents intended for use in blood source screening and radiolabeled defined as drugs, all of other IVD are medical devices (MD).

However, based on actual needs, IVD reagents is distinguished and defined solely. A set of provisions issued in April to May 2007 are related to manufacturing, quality system, product registration for market approval and distribution of postmarket control. IVD reagents are defined in section 3 of Management Method of In Vitro Diagnostic Reagents Registration (Interim) taken effect as of June 1, 2007.

In vitro diagnostic reagents that are administrated as medical devices, include any reagent, kit, calibrator, quality control product (substance) and so on, whether used alone or in combination with instrument, apparatus, appliance and system, intended to be used in vitro for the examination of human specimens taken from human body(various body fluid, cells and tissue samples, etc.) during the prevention, diagnosis, treatment and sequelae observation of disease, health evaluation as well as the prediction on hereditary disease.

Meanwhile based on the product risk, IVD reagents are classified into class III, II and I. Moreover, some reagents are listed in each classification as example.



Therefore, IVD in China is subject to the whole set of MD requirements of regulations and provisions, and there is no specific regulations aimed at IVD. However IVD reagents define solely and are subject to not only a whole set of MD regulations but also its specific requirements of provisions. For an IVD system contained the instrument and suited reagents, two product registration certificates have to be acquired for the market approval complied with two different and absolute regulatory systems and procedures, Medical Device Registration for the instrument and IVD Reagent Registration for suited reagents.

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