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 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
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 […]