China accelerates medical device innovation. In January 2018, four products got approved through fast track pathway in January.
Keep up to date with weekly CFDA News Roundup covering policy, standards, guidelines, recalls/AE/QA and new approvals. Click HERE to opt-in or email info@chinameddevice.com
- United Imaging: medical linear accelerator system
- Edwards Lifesciences: transcatheter heart valve and accessory
- Bohui: Repair patch with anastomotic stoma
- RaySoultion: positron emission and X-ray tomography scanning system
We also publish market access monthly newsletter, click HERE
For more detailed information or English version of the documents, please contact us at info@ChinaMedDevice.com
About China Med Device, LLC
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
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------