March 5, 2018

China Approves First Device through Marketing Authorization Holder Program, Green Lights Contract Manufacturing

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 (Feb 25th to Mar 4th)

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: Propels China to Leadership

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

3D Printed Medical Device Technical Review Guideline Outline

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: 37 Violations from 8 Foreign Device Manufacturers

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, […]