CFDA Updates

December 23, 2017

CFDA Greenlighted A Treatment of Chronic Heart Failure in China

The Germany-based Impulse Dynamics just announced that China’s CFDA has approved its Optimizer® system for treatment of chronic heart failure.  Impulse Dynamics’ CEO, Dr. Simos Kedikoglou noted “this is a […]
December 22, 2017

Regulatory Affairs Event with CFDA Delegates a Success!

China Med Device and CABA held a quarterly Regulatory Affairs  event with CFDA representatives from Beijing in Cambridge, MA on Sunday, December 10. Nearly 50 Regulatory representatives from U.S. Medtech […]
December 20, 2017

Why Is It Taking One Year to Migrate to China’s New Medical Device Classification System?

The newly revised Medical Device Classification Catalog (hereinafter referred to as the “Classification Catalog”) released by China’s State Food and Drug Administration (CFDA) was officially released on August 31 this […]
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 […]