CFDA Updates

January 2, 2018

Stratasys and GE Healthcare China Form Strategic Partnership

According to Gartner, 30% of internal medical implants and devices in the medical field will use 3D printing technology by the year 2020. Considering China has become world’s 2nd larget […]
December 29, 2017

CFDA Approved In-Vitro Diagnostic (IVD) Reagents For Liver Cancer Detection

CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual property rights. This means that […]
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 […]