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, […]
February 27, 2018

Weekly CFDA News Roundup (Feb 18th to Feb 24th)

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 […]
February 23, 2018

CFDA Quality Notice: 5 Foreign and 52 Domestic are impacted

CFDA issued a Quality Notice and identified 8 types of medical devices with quality issues: RF ablation system, X-ray imaging system, oxygen concentrator, biomedical freezer, surgical blade, etc. 5 foreign […]