Shanghai CFDA: 17 Foreign Devices Recalled

Weekly CFDA News Roundup (Feb 11 to Feb 17)
February 20, 2018
CFDA Quality Notice: 5 Foreign and 52 Domestic are impacted
February 23, 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 pressure transducer

•          Bausch & Lomb: intraocular lens

•          Siemens: cyclosporine assay

•          Roche: automatic urine analyzer

•          Zimmer Biomet: hip prosthesis

•          Maquet: shadowless operation light

•          Smith & Nephew: orthopedic external fixation system

•          Philips: X-ray angiography system

•          Roche: monoclonal antibody reagent

•          BD Medical: medium for gram-negative bacteria

•          Beckman Coulter: immunoglobulin A assay kit

•          GE: respiratory system

•          Boston Scientific: spy scope access and delivery catheter

•          Xpert: mycobacterium tuberculosis complex

•          Abbott: glycosylated hemoglobin

•          Philips: emission computed tomography system 

 

About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.