June 14, 2018
This year, CFDA has issued 8 technical guidelines, 1 innovation approval and 1 class I recall for blood-related medical devices. Guideline: Technical Guideline on Continuous Glucose Monitoring Device; Technical Guideline […]
June 13, 2018
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 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
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
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 […]