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, […]
February 27, 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 […]
February 23, 2018
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 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 […]
February 20, 2018
CFDA is celebrating Chinese New Year, the year of the dog. There were limited updates for last week. Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in […]