Blogs

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 […]
February 20, 2018

Weekly CFDA News Roundup (Feb 11 to Feb 17)

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 […]
February 16, 2018

Reimbursement Change Calls for Quality IVD

To control the rising healthcare cost, China has established a prospective payment system (PPS) to reimburse hospitals for the treatment of patients; from diagnosis to full recovery. The PPS is […]