China Expands LDT Pilot Program: 18 More Medical Institutions Join to Boost Innovation in IVD

China has officially launched the second phase of its pilot program for Laboratory Developed Tests (LDTs), marking another significant step in promoting innovation and self-reliant diagnostic capabilities across its healthcare system.

In a joint announcement issued by the National Medical Products Administration (NMPA) and the National Health Commission (NHC), 18 additional hospitals have been approved to join the ongoing pilot program allowing medical institutions to independently develop and use their own in vitro diagnostic (IVD) reagents.

This follows the initial rollout in 2023, which selected 11 top-tier hospitals to lead the first phase. The expansion reflects China’s strategic commitment to fostering new quality productive forces in diagnostics, particularly through advanced technologies and rare disease testing.

First Batch (2023) – 11 Institutions 

Beijing: Peking Union Medical College Hospital, Beijing Hospital, China-Japan Friendship Hospital, Cancer Hospital (Chinese Academy of Medical Sciences), Fuwai Hospital, Peking University First Hospital

Shanghai: Fudan University Cancer Hospital, Shanghai Children's Medical Center, Zhongshan Hospital (Fudan University), Ruijin Hospital (Shanghai Jiao Tong University)

Guangdong: The First Affiliated Hospital of Guangzhou Medical University

Second Batch (2025) – 18 Institutions 

Beijing:

-       Beijing Children’s Hospital, Capital Medical University

-       Peking University People’s Hospital

-       Peking University School and Hospital of Stomatology

-       Xuanwu Hospital Capital Medical University

-       Beijing Tiantan Hospital, Capital Medical University

-       Beijing Ditan Hospital, Capital Medical University

-       Peking University Sixth Hospital

-       Beijing Anding Hospital, Capital Medical University

-       Beijing Jishuitan Hospital

Liaoning:

-       The First Hospital of China Medical University

Shanghai:

-       Children’s Hospital of Fudan University

-       Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine

-       Huashan Hospital Fudan University

-       Shanghai Mental Health Center

-       Shanghai Sixth People's Hospital

Zhejiang:

-       The First Affiliated Hospital, Zhejiang University School of Medicine

Hubei:

-       Tongji Hospital (Huazhong University of Science and Technology)

Sichuan:

-       West China School of Stomatology, Sichuan University

Hospitals selected for the program must voluntarily apply and are subject to a regulated guidance catalog for test development. Each institution may initially propose up to 10 testing items, with a strong encouragement to include rare disease diagnostics among them.