CFDA is celebrating Chinese New Year, the year of the dog. There were limited updates for this week.
Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
For a complimentary consultation, email gpalma@ChinaMedDevice.com. Keep yourself updated with CFDA News, click HERE to opt-in. We also publish market access newsletter, click HERE
QA/recall/AE:
- CFDA issued Quality Notice and identified 8 types of medical devices with quality issues: RF ablation system, X-ray imaging system, oxygen concentrator, biomedical freezer, surgical blade, vaginal dilator, surgical gown and tomography X-ray system. 5 foreign and 52 domestic medical devices are impacted.
- Shanghai local CFDA announced Medical Device Recall Notices from 17 foreign device manufacturers. Philips, Abbott, Roche, Siemens, Edwards and Boston Scientific are on the list.
For more detailed English documents, please contact us at info@ChinaMedDevice.com
Keep yourself updated with Weekly CFDA News Roundup, click HERE to opt-in. We also publish market access monthly newsletter, click HERE
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.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------