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 […]
May 30, 2018

Join Our Webinar: Key Ingredients for Effective China SDA(CFDA) CER and Clinical Trial

Which is your clinical pathway in China, CER or Clinical Trials? How to get oversea clinical data accepted by China SDA? How can you use CFDA unapproved device in China […]
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 ( a […]