CFDA Updates

December 16, 2017

CFDA Released China Medical Device Registration Unit Classification Guidelines

On November 23, CFDA issued official Guidelines on Medical Device Registration Unit Classification, which mainly focus on the technical principles, structural components, performance indexes, scope of application and packaging specifications […]
December 11, 2017

AI-Aided Diagnosis A Focus Under the New CFDA Medical Device Classification

The new “medical equipment classification directory”   In recent years, the rapid development of China’s medical device industry, at present there are about 77,000 valid registration certificates of medical devices […]
December 4, 2017

Highlights of CFDA’s Plan To Implement Review and Approval System Reform and Encourage Drug and Medical Device Innovation in China

  Highlights of CFDA’s Plan To Implement Review and Approval System Reform and Encourage Drug and Medical Device Innovation in China In October 2017, China’s Central Government’s State Council promulgated […]
December 2, 2017

CFDA Approves ORTHO VISION Platform for Blood Transfusion

Ortho Clinical Diagnostics announced that its ORTHO VISION Platform of fully automated blood analyzers for low-, mid- and high-volume transfusion medicine laboratories has received approval by the CFDA. The platform […]
November 28, 2017

EYE TECH CARE’s Glaucoma Treatment Product Receives CFDA Approval

EYE TECH CARE, a French medical device company, has received approval from CFDA to begin marketing its EyeOP1® glaucoma treatment product in China. The first non-invasive medical device approved for […]