CFDA Released 8 Medical Device Industry Standards and a Modification, Including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General Requirements”

CFDA Update: iCAD’s Xoft Axxent Balloon Applicators Approved for Early-Stage Breast Cancer
September 11, 2017
Trendlines And China’s Haier To Collaborate In Medtech Startups
September 22, 2017

CFDA Released 8 Medical Device Industry Standards and a Modification, Including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General Requirements”

CFDA Release

Recently, CFDA released 8 medical device industry standards and a modification including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General requirements” and YY 0669-2008, the first Revision – the “Medical Electrical Device,Part 2: the Specific Safety Requirements of Baby Light Treatment Device”. Please check the appendix for the approval number, name, scope of application, date of implementation and contents of the modification.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.