Clinical Trial and CFDA Inspection Success for Hemostatic Powder by ChinaMed Device, LLC

2018 CFDA Medical Device Registration Report
June 21, 2019
Suspension of Importation to China by CFDA after Overseas Inspection
June 27, 2019

Clinical Trial and CFDA Inspection Success for Hemostatic Powder by ChinaMed Device, LLC

ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA (CFDA) onsite inspection success for its absorbable hemostatic powder.  CMD’s proven approach of integrating technical, clinical and regulatory knowledge and experience has overcome the challenges along the way and expedited clients’ time to Chinese market.

As a Class III absorbable implants, the NMPA regulatory registration and clinical evaluation of this hemostatic powder certainly encountered challenges. ChinaMed Device’s team under the guidance of its clinical director, Jason Zhang, MD with the support of the China CEO, Tony Liu, helped the client to identify the more appropriate pathway to deal with the stalemate of NMPA clinical trial process. ChinaMed Device obtained the IRB approval in 2 months, completed 700 patients enrollment within 6 months, and finished the clinical report in one month. What is more remarkable is that CMD team evaluated, adjusted the clinical strategy and finished the complete whole clinical trial process in 10 months without having NMPA issuing any supplement requests or corrections!

In addition, CMD gave the client QMS training and conducted mock inspection on their factory before NMPA inspection. With CMD suggestions and guidance, they successfully passed the NMPA inspection at the 1st time inspection.

Keep yourself updated with NMPA (CFDA) Newsletter, click HERE to opt-in. Click HERE for our clinical trial/CER webinar, click HERE for GMP/QMS webinar, click HERE for NMPA overseas inspection webinar.

About China Med 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 set up local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, 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.