CFDA quality requirements have escalated. From Mar 18 to Mar 24, CFDA announced Medical Device Recall Notices from 17 foreign manufacturers for 22 medical devices. Boston Scientific, Siemens, Becton Dickinson, GE, Smith & Nephew are on the list.
If you are not clear about CFDA recall process, or need model information and reasons for recall, email gpalma@ChinaMedDevice.com
- Boston Scientific: generator for the thermal coagulation necrosis
- DiaMed: automated analyzer system
- GE: Infant Incubator
- Smith & Nephew: surgical needle
- Stryker Instruments: personal protective equipment (PPE)
- Ortho Clinical Diagnostics: thyrotropin assay
- Edwards Lifesciences: programmable diagnostic computer
- GE: programmable diagnostic computer
- Boston Scientific: suture capturing device
- Boston Scientific: vaginal support system
- Cook: vacuum pump
- Zimmer: dental instrument kit
- Johnson & Johnson: absorbable suture
- ArjoHuntleigh: patient handling system
- Draeger Medical: anesthesia machine
- Siemens: computed tomography
- Zimmer: total elbow replacement
- Deerfield Imaging: magnetic resonance imaging system
- Fuji: endoscopy
- Beckman Coulter: sample processing system
- Aesculap AG: penis clamp
- Cook: benchtop incubator
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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, 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.