[A Brief Analysis of the Regulatory Model for In-House Development and Use of In Vitro Diagnostic Reagents by Medical Institutions in Shanghai].

At the end of 2022, China initiated a pilot program for in-house development and use of in vitro diagnostic reagents by medical institutions. This study compares the evolution of laboratory developed tests（LDTs） regulation in the United States and the requirements for "in-house devices" under the EU IVDR with China's pilot policies, systematically summarizes Shanghai's "national selected varieties+provincial filing+joint supervision" practice model, and identifies challenges such as difficulties in unifying technical evaluation standards, insufficient clinical evidence, and difficulties in implementing primary responsibility. Recommendations are proposed, including establishing a tiered evaluation system, exploring real-world data applications, and strengthening full-life-cycle supervision, aiming to provide insights for improving the national regulatory framework for in-house reagents.