Weekly CFDA News Roundup (Feb 11 to Feb 17)

New CFDA Technical Review Guideline for CT
February 13, 2018
Shanghai CFDA: 17 Foreign Devices Recalled
February 21, 2018

Weekly CFDA News Roundup (Feb 11 to Feb 17)

CFDA is celebrating Chinese New Year, the year of the dog. There were limited updates for last 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 China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.

QA/recall/AE:

  1. 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.
  2. 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.

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, 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.