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

Authors

Anting Wang, Shuang Liang

Published in

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation. Volume 50. Issue 5. Pages 558-562. Sep 30, 2026.

Abstract

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.

PMID:
42865057
Bibliographic data and abstract were imported from PubMed on 13 Oct 2026.

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