CFDA Updates

February 8, 2018

Edwards Lifesciences got innovation approval from China CFDA

China accelerates medical device innovation. In January 2018, four products got approved through fast track pathway in January. United Imaging: medical linear accelerator system Edwards Lifesciences: transcatheter heart valve and […]
February 1, 2018

Chinese Central Government Wants to Reach Medical Device International Standardization Faster

CFDA implements this 3-year plan to support central government’s effort to make medical device regulations more consistent with international standards. 300 standards for medical devices and IVDs could be expected […]
January 31, 2018

Weekly CFDA Updates(Jan 22-29, 2018)

CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018:   1. Policy: CFDA announced Comprehensive Regulatory Plan for Medical […]
January 30, 2018

2018 CFDA Changes in IVD Product Classification

On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS, immunohistochemistry and in situ hybridization. […]
January 29, 2018

CFDA Must Read—— New Guideline for Medical Device Oversea Inspection

The CFDA is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. In the past, very rarely did the national CFDA make public […]