"IVD" is called "in vitro diagnostic products", which is translated as "in vitro diagnostic products" in Chinese, and IVD refers to medical devices, in vitro diagnostic reagents, and pharmaceuticals. As a branch of medical devices, IVD has its own definition and regulation.
In the international arena, IVD as a separate branch of medical devices has its own unique definition and regulatory system, especially the U.S. Food and Drug Administration (FDA) and the European Union (EC).
IVD mainly includes instruments, reagents or systems used for in vitro diagnosis. However, the situation is different in China, where IVD is not independently distinguished and defined, i.e., there is no concept of IVD. Instead, the usual international concept of IVD includes products that are broken up and subordinate to Medical Devices (MD), In Vitro Diagnostic Reagents (IVD Reagents), and Pharmaceuticals, respectively.
In China, except for in vitro diagnostic reagents for blood screening and radionuclide labeling, which are defined as drugs, all other IVD products belong to medical devices (MD).
The definition of medical device in China's State Council in 2000, No. 276, "Medical Device Supervision and Administration Regulations" provides. Medical devices are instruments, equipment, appliances, materials or other items, including the required software, that are used alone or in combination in the human body.