"IVD" is the full name of "in vitro diagnostic products", Chinese translation for in vitro diagnostic products, IVD refers to medical devices, in vitro diagnostic reagents and pharmaceuticals. IVDs are medical devices, in vitro diagnostic reagents, and pharmaceuticals, and as a branch of medical devices, IVDs have unique definitions and regulations.
Internationally, IVD as an independent 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.
But in China, the situation is different, IVD has not been independently distinguished and defined, that is, there is no concept of IVD. Instead, the products included in the usual international concept of IVD are broken up and belong to Medical Devices (MD), In Vitro Diagnostic Reagents (IVD Reagents), and Pharmaceuticals, respectively.
The state classifies and manages medical devices according to the level of risk.
1, the first category is a low-risk, routine management can ensure the safety and effectiveness of medical devices.
2, the second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
3, the third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.