Research on the Standardization System of In Vitro Diagnosis Products at Home and Abroad

Objective The quality of in vitro diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.Methods Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.Results China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.Conclusion Some suggestions are put forward to provide references for strengthening supervision of IVD products.