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 […]
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) […]
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) […]
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 […]
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 […]
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 […]
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 […]
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 (www.ChinaMedDevice.com) a […]
The global application of molecular diagnostics has gradually evolved from the initial diagnosis of infectious diseases to the current personalized treatment and genetic disease screening, which has highly promoted precision […]
According to the statistics of China Blueprint for In Vitro Diagnostic, as of 2016, the size of China’s immunodiagnostic market reached 16.2 billion RMB (2.61 billion USD), accounting for 33% […]
Due to the impact of the birth control policy and the decline in birth rate after the economy growth, the population structure in China is gradually entering an aging society. […]
Weekly CFDA News Roundup covers policies, industry standards, guidance, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting […]