“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. China Med Device, LLC 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@ChinaMedDevice.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.
For the clinical non-compliances of the above manufacturers, please click HERE.
For common issues in Clinical Trial Audits, please click HERE.
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@ChinaMedDevice.com. We charge nominal fees for the translation.
For the presentation on clinical & CER that we shared on RAPS Convergence, please email us also.
For the webinar on China Clinical Pathways we did in November 2019, please click HERE.
To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.