CFDA quality requirements have escalated. In the month of May, CFDA announced 31 Medical Device Recall Notices from 21 foreign manufacturers.
1. There are 2 level I recalls; level I recall is the most urgent type of recall CFDA issues:
1) Abbott: implantable defibrillator (firmware upgrading)
2) Magellan: blood lead analyzer (inaccurate testing results)
2. Major foreign manufacturers, GE, Philips, Siemens, Abbott, Boston Scientific, Edward Lifesciences, Becton Dickinson, Stryker and Smith & Nephew, are on the recall list.
3. Smith & Nephew got 5 recalls this month, covering orthopedics and hematology.
· Smith & Nephew: 1) locking plate; 2) bone needle; 3) knee surgical device; 4) external fixation system; 5) RF plasma surgery system
· Philips: 1) infant incubator; 2) x-ray angiographic system; 3) defibrillator
· GE: 1) mobile x-ray system; 2) x-ray bone density detector; 3) infant incubator
· Medtronic: 1) heater/cooler system; 2) plasma filter
· Boston Scientific: 1) pelvic floor repair system; 2) pacemaker wire
· Abbott: implantable defibrillator
· Magellan: blood lead analyzer
· Siemens: gentamicin assay kit
· Becton Dickinson: vacuum blood collection tube
· Edwards Lifesciences: oximetry monitor
· Stryker: ultrasonic surgical aspirator system
· Maquet: ventilator
· Zimmer Biomet: hip stem
· Beckman Coulter: automatic urine analyzer
· Mindray: automatic immunoassay analyzer
· Bellco Hoxen: plasma filter
· Biotronik: peripheral stent
· Deerfield Imaging: MRI system
· Biomet Othopedics: knee replacement
· ConvaTec: intra-abdominal pressure monitor
· DiaMed: blood grouping reagent IH-card
For the reason of recall and the model number, please email info@ChinaMedDevice.com.
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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, QA, post market compliance. We are certified as legal agent. 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+ companies’ success.