Analysis of the Current Status and Difficulties of Transforming Laboratory Developed Test from Medical Institutions into In Vitro Diagnostic Reagents

At present, although laboratory developed test (LDT) have been incorporated into the regulatory framework for medical devices in Chnia, there remain gaps in normative oversight within practical regulatory implementation. From the perspective of registration transformation, this paper systematically compares the disparities between LDT and the existing in vitro diagnostic reagent (IVD) market registration system, analyzes the key difficulties and challenges in the registration transformation process of LDT, and puts forward corresponding suggestions. It aims to provide decision-making references for regulatory authorities when formulating requirements for the market transformation of LDT.