March 27, 2018

CFDA: 22 Foreign Devices Recalled Last Week

CFDA quality requirements have escalated. From Mar 18 to Mar 24, CFDA announced Medical Device Recall Notices from 17 foreign manufacturers for 22 medical devices. Boston Scientific, Siemens, Becton Dickinson, […]
March 23, 2018

New Leaders of CFDA, with More Expertise, Emerged

The cabinet Reshuffle Plan, unveiled by China’s State Council on 13 Mar, established the National Market Supervision Administration (NMSA). CFDA, along with Administration for Industry & Commerce (AIC), and Administration […]
March 21, 2018

Weekly CFDA News Roundup (Mar 11th to Mar 17th)

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 […]
March 20, 2018

CFDA Held Forum for 3D Printed Device

Industry forum for additive manufactured (3D-printed) medical device was held by CFDA on 12 March. 70 experts, physicians, manufacturers and CFDA reviewers attended the forum to discuss the details of […]
March 19, 2018

Concentrated Care in China Facilitates Clinical Trial Recruitment and Data Gathering

Source: New York Times China does not have a distributed primary and community-based network of healthcare.  The picture here may make you think Chinese are waiting in line for football […]