March 5, 2018
China’s State Council announced a pilot program for medical device Marketing Authorization Holder (MAH) System at Shanghai free trade zone on Jan 5, 2018. On Feb 27, first approval through […]
March 5, 2018
Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing […]
March 1, 2018
New 3D printed medical device draft guideline will propel China to be the leader in innovation & market acceptance in orthopedic and dental applications. CFDA issued “customize-designed additive manufactured […]
March 1, 2018
Introduction CFDA developed this document to provide guidance to industry and CFDA staff about current technical review for customize-designed additive manufactured (3D-printed) medical device. I. Scope The requirements in this […]
February 28, 2018
CFDA overseas inspection has intensified. On Feb 27, 2018, CFDA announced overseas inspection results from 8 foreign medical device manufacturers with 37 observations. If you need details of these observations, […]