CFDA Approval

To bring their medical devices to the Chinese market, foreign companies need to obtain approval from the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). 

EcoKMC Suzhou works in partnership with KTTN to gain NMPA approval for participating companies. KTTN is a clinical research consulting and medical technology company with extensive experience in conducting domestic and foreign medical device clinical trials, filing project applications, project management, business consulting, and outsourcing services.

KTTN assists EcoKMC’s clients with pre-marketing guidance, medical device inspection and registration, preparation of reports, and integrated technical support. Projects that KTTN has facilitated for EcoKMC have a 100 percent passing rate for NMPA applications.

Founded in 2012 by two medical professionals with more than 20 years of experience, KTTN is a leader in the field and has been involved in drafting industry standards for the contract research organization (CRO) standard committee. KTTN has also been invited to participate in the revision of the guiding principles of the CRO review center, thus improving the effectiveness of CRO guiding principles.