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2026 China NMPA Bluebook is here:
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
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
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
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
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
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
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
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
China Med Device cordially invites you to our latest regulatory event in Boston on December 10th, 2017 and the opportunity to meet face to face
CryoLife, a US-based medical device and tissue processing company focused on cardiac and vascular surgery, announced that enrollment has started in the company’s BioGlue clinical
CFDA just released a Solicitation for Public Comments (SPC) for its proposed amendment of the Medical Device Regulations (MDR), as mandated by a recent order
On October 8th, China State Council released guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug innovation for comments. The guidelines contain