1380 Institutes Certified to Conduct Clinical Trials in China

“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions for Medical Device Clinical Trial Sites”.

Since February 2005 when NMPA (then CFDA) published the first batch of medical device clinical sites, a total of 1380 hospitals became certified to conduct clinical research in China as of April 2024.

All 1380 sites have different clinical specialties registered with NMPA. We can help you select the right hospital and save time for market introduction.

For the complete list of the clinical trial institutes, please email us at info@ChinaMedDevice.com.

Strict Clinical Audit

The clinical audits are also conducted at those sites. The clinical trial requirements are strengthened over the years, and well-known companies found non-compliant include Siemens and Medtronic.

IVD companies facing increased scrutiny in clinical audits were identified as Siemens from Germany, RSR from UK and Q-Med from Sweden.

Click HERE for the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” issued in March 2024

For the clinical non-compliances of the above manufacturers, please click HERE

For common issues in Clinical Trial Audits, please click HERE

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• Source: https://chinameddevice.com/clinical-trial-institutes/