NMPA Update: 846 Hospitals Certified to Conduct Clinical Trials

“Regulation of Medical Device Clinical Trial Quality Management (so called China GCP)” issued on March 1, 2016 specifies that “Clinical trial sites must be on the NMPA filed institutions for Medical Device Clinical Trial Sites”. The new policy became mandatory on January 1, 2019.

Since February 2005 when NMPA (then CFDA) published the first batch of medical device clinical sites, a total of 846 hospitals filled with NMPA as clinical sites in China. 170 hospitals became certified to conduct clinical research in 2019.

All 846 sites have different clinical specialties registered with NMPA. Bradynuoen has 10+ years CRO experience and has long-term relationship with some hospitals. In order to select the right hospital and save time for market introduction, please email info@inspirativemed.com

Strict Clinical Audit

The clinical audits are also conducted at those sites. The clinical trial requirements strengthened over the years, and as of 2018, ten manufacturers out of twenty have been identified with issues in clinical trial audits; well-known companies that were cited are 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.

Establish NMPA Complied GCP

How to ensure your Medical Device/ IVD Good Clinical Practice (GCP) complies with NMPA (CFDA) ever changing requirements? Please refer to “Medical Device Clinical Trial Guideline” issued in January, 2018 and “Draft IVD Clinical Trial Guideline for Feedback” issued in November, 2018.

For an English version of the two documents, please email info@inspirativemed.com. We charge nominal fees for the translation.

For the presentation on clinical & CER that we shared on RAPS Convergence, please email us also.