CFDA issued medical device recall reports to 16 manufactures from Jan 28th to Feb 3rd. There are six foreign manufacturers on the list:
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- Edwards Lifesciences: venous sheath
- Hologic, Inc: nucleic acid detection system
- Boston Scientific: implantable pacing lead
- Biomet Orthopedics: shoulder joint prosthesis
- Smith & Nephew: external fixation system
- Philips Medical Systems: tomography X-ray system
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We provide turn-key solutions for western medical device/IVD companies to enter China with regulatory and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our management team in Boston and Beijing have processed 1,200+ certificates. Email info@ChinaMedDevice.com or visit www.ChinaMedDevice.com
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------