Blogs

June 13, 2018

Weekly CFDA News Roundup (June 3rd to June 10th)

Weekly CFDA News Roundup covers government reports, policies, 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 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

It’s Official: CFDA Innovation Approval Guideline Effective Dec 1, 2018

On November 5, 2018, NMPA (CFDA) published final guideline “Special Review and Approval Procedure for Innovative Medical Devices” per CFDA notice No.13 2014. The guideline focuses on establishing a gradation […]
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 […]