CFDA Updates

June 11, 2018

Monthly CFDA News Roundup (May 2018)

Monthly CFDA News Roundup covers policies, government reports, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) […]
June 8, 2018
CFDA guidelines

CFDA Innovation Approval Draft Guideline Summary

On May 7, 2018, China Food and Drug Administration (CFDA) published a draft guideline “Special Review and Approval Procedure for Innovative Medical Devices” per CFDA notice No.13 2014. The proposed […]
June 6, 2018

New Batch of Innovative and Priority Devices was Approved by CFDA; J&J and Medtronic were Included

CFDA granted 4 medical devices Innovation Approval, and 1 device Priority Review on May 22. Johnson & Johnson and Medtronic are on the list. Innovation Approvals: Medtronic: percutaneous implanted aortic […]
June 6, 2018

CFDA: Abbott and Magellan Got Level I Recall

CFDA quality requirements have escalated. In the month of May, CFDA announced 31 Medical Device Recall Notices from 21 foreign manufacturers. 1.      There are 2 level I recalls; level I […]
May 29, 2018

Weekly CFDA News Roundup (May 20th to May 26th)

Weekly CFDA News Roundup covers government reports, policies, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (www.ChinaMedDevice.com) a […]