China currently has 1,380 healthcare institutions authorized to conduct clinical trials, in accordance with the "Quality Management Practice Specification for Clinical Trials of Medical Devices" (known as China GCP) implemented since March 2022. These are for regulatory approval trials qualified institutions. There are thousands of hospitals in China, but not all institutions are qualified to do clinical trials for regulatory approvals. The trials in China must be conducted at hospitals listed in order to be accepted by China NMPA.
Since February 2005, when NMPA published the first batch of medical device clinical sites, a total of 1,380 can perform clinical trials as of April 2024. Each of these sites specializes in different clinical specialties registered with the NMPA.
Selecting the right hospital for your trials is crucial for the quality, time, and cost of the trials. These institutes undergo strict clinical audits to ensure compliance with evolving clinical trial requirements. Over the years, the standards have become more matured and stricter, even some large well-known companies have been found non-compliant.
Clinical trial audit has become more common in past few years in China. The audits could be coming from the hospital or NMPA. Make sure you think ahead and factor in the audit time. Not all sponsored hospitals require this, but some do.
Have you been audited with your clinical trials? Appreciate your sharing your experience. If you are interested in more details on clinical trial audits, let me know.
Also, please feel free to reach out if you would like a complete list of the clinical trial institutes.
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Grace Fu
China Med Device, LLC
gpalma@ChinaMedDevice.comPhone US: (978) 390-4453
Phone China: 18201749732
www.ChinaMedDevice.com------------------------------