Addressing the rapid development of in-vitro diagnostics technologies and their increasing usefulness, China’s National Medical Products Administration (NMPA) in November refined its system of classifying in-vitro diagnostic (IVD) devices to better reflect the varying levels of risk they contain.
Under the new classification system, IVD devices are classified into four categories, A to D, with Class A the category of lowest risk and Class D the highest. The new system is intended to make it easier for the NMPA to oversee the safety of IVD use in China.
Low risk agents such as microbiological media identification kits for cultured microorganisms, wash solutions, instruments and plain urine cups are Class A. Pregnancy self-tests, fertility testing and urine test strips are considered Class B. Most IVD medical devices for blood grouping or tissue are classified as Class C.
And devices are classified as Class D if they are used to detect a transmissible agent in blood, blood components, tissues or organs. Devices to detect a transmissible agent that causes a life-threatening, often incurable, disease with a high risk of propagation are also Class D.
The rules for determining the class of an IVD are listed at length in Technical Reference TR-006, guidelines published by the Global Harmonization Task Force.