What are in-vitro diagnostic reagents?

According to China's "Registration and Administration Measures for In Vitro Diagnostic Reagents" issued in 2014, in vitro diagnostic reagents (IVDs) managed as medical devices are reagents, reagent kits, calibrators, quality control products, etc., used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis investigation, and health status assessment.

What are in vitro diagnostic reagents?

According to China's "Registration and Administration Measures for In Vitro Diagnostic Reagents" issued in 2014, in vitro diagnostic reagents (IVDs) administered as medical devices are reagents, reagent kits, calibrators, quality control products, etc., used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis investigation, and health status assessment. They can be used independently or in combination with instruments, tools, equipment, or systems.

Currently, disease prevention and clinical diagnosis basically require the use of in vitro diagnostic reagents. Whether it's the three routine tests of blood, urine, and stool, or the identification of viral and bacterial infections, or examinations of cardiovascular, liver, kidney, and immune function, they all rely on in vitro diagnostic reagents.

Are all in vitro diagnostic reagents medical devices?

In China, most in vitro diagnostic reagents are managed as medical devices, while some are managed as pharmaceuticals. Those managed as pharmaceuticals mainly include in vitro diagnostic reagents used for blood source screening and those using radioactive nuclides as labels; these products do not belong to medical devices. All in vitro diagnostic reagents on the market must be registered or filed with the food and drug administration, obtaining the relevant medical device registration certificate or filing certificate.

Which units mainly use in vitro diagnostic reagents?

In vitro diagnostic reagents fall under the category of medical device administration. In China, medical device users refer to organizations that use medical devices to provide medical and other technical services to others, including medical institutions with medical institution licenses, family planning technical service organizations with family planning technical service organization licenses, and blood banks, single plasma collection stations, and rehabilitation assistive device fitting organizations that are legally not required to obtain medical institution licenses.

Where can the public find information on in vitro diagnostic reagents?

When understanding and identifying information related to in vitro diagnostic reagent products, the public can log on to the official website of the National Medical Products Administration (www.nmpa.gov.cn) to check relevant information under "Data Query", or check relevant information on the websites of the food and drug administration in relevant regions, or consult the food and drug administration.