Weekly CFDA News Roundup (Mar 4th to Mar 11th)

Chunli Orthopedic got 2 innovation approvals from CFDA
March 9, 2018
CFDA’s Name is Disappearing as China Announces Cabinet Reshuffle Plan
March 13, 2018

Weekly CFDA News Roundup (Mar 4th to Mar 11th)

Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.


  1. CFDA announced recall notices from 4 manufacturers:
  • Edwards Lifesciences: transcatheter heart valve
  • Boston Scientific: venous endoprosthesis
  • Dako North America: trichrome stain kit
  • Smith Medical ASD: intravascular administration set
  1. CFDA published adverse event notification for reusable uterine sound.

New Approval

CFDA announced innovation approvals to 7 medical devices, covering orthopedics, cardiology, hematology, oncology, etc. No foreign manufacturers are on the list. Read More

  • Microport: eluting coronary stent
  • Anhan Medtech: capsule endoscopy system
  • Chunli Orthopedic: unicompartmental knee prosthesis
  • Chunli Orthopedic: joint replacement prosthesis
  • Origin Medtech: polymer clamp
  • ZhiGeno: echinococcus spp. serological reagent
  • NovoGene: EGFR t790m mutation reagent