CFDA Updates

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 […]
February 21, 2018

Shanghai CFDA: 17 Foreign Devices Recalled

Shanghai CFDA office announced Medical Device Recall Notices to 17 foreign device manufacturers from Feb 11th to Feb 17th: •          Konica Minolta: diagnostic ultrasound system •          Edwards Lifesciences: disposable blood […]