Shanghai CFDA office announced Medical Device Recall Notices from 17 foreign device manufacturers from Feb 11th to Feb 17th:
For a complimentary consultation, email gpalma@ChinaMedDevice.com. Keep yourself updated with Weekly CFDA News Roundup, click HERE to opt-in. We also publish market access monthly newsletter, click HERE
- 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
Keep yourself updated with Weekly CFDA News Roundup, click HERE to opt-in. We also publish market access monthly newsletter, click HERE
For more detailed English documents, please contact us at info@ChinaMedDevice.com
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 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, 60+ western companies' entry.
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------