Analysis of Registration Status of Class A and Class B Infectious Diseases In-Vitro Diagnostic Medical Devices in China

• 1、School of Informatics, Xiamen University Xiamen, Fujian 361005, China

Abstract：The infectious diseases are categorized into three classes for epidemic reporting and management in China. Timely monitoring and effective control of infectious diseases are crucial for handling public health emergencies. This not only aids in the rapid identification of outbreaks but also effectively curbs virus transmission, protecting public health. In-vitro diagnostic reagents are important tools for rapid screening and early diagnosis of infectious diseases. Rapid and accurate data collection is vital for controlling disease spread, reducing patient deterioration, and decreasing mortality rates. This paper surveys and analyzes the registration of Class A and Class B controlled infectious diseases related to in-vitro diagnostic (IVD) medical device products in China. It studies the registration numbers and proportions of domestic and imported in vitro diagnostics, discusses the reasons for the current gaps in the registration of infectious disease diagnostics, and reviews the registration details of specific types of diagnostics for SARS-CoV-2 and viral hepatitis.

Keywords： infectious disease COVID-19 medical device in-vitro diagnositc reagent