CFDA Updates

July 20, 2017

CFDA Issued new guidelines on HP Antigen/Antibody Testing Regent and 3 More Medical Device/IVD for Comments

CFDA has issued 4 new guidelines from June 29rd to July 4th. Two of them are for IVD registration and the other two is for medical device. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review or new submission phase. Find out how these guidelines impact your devices in China, please contact us at info@ChinaMedDevice.com.

  1. The registration technical review guideline for Helicobacter Pylori (HP) Antigen / Antibody Testing Reagent for comments.
  2. The technical review guideline on HCV Genotyping Testing Reagent for comments.
  3. The clinical evaluation technical review guideline on Endometrial Removal Equipment for comments.
  4. Clinical evaluation technical review guideline on Proton/carbon Ion Treatment System
July 20, 2017

CFDA Wants to Ensure Quality of Data In Medical Device Registration

As part of its effort to ensure the quality of data in medical device filings, CFDA has published documents to overhaul the regulation of how medical devices are developed and […]
July 12, 2017

Sciex Mass Spec System Approved by CFDA

  Sciex said today that its AB Sciex Triple Quad 4500MD LC-MS/MS system has been approved by the China Food and Drug Administration for use as a medical device.   […]
July 5, 2017

CFDA Updates: Priorities of CFDA 2017 Reform Related to Medical Device, MedTech, IVD

    In a press conference held earlier this year by CFDA, the agency declared that it would be pursuing its reform of the drug and medical device approval system […]
July 5, 2017

CFDA Updates: Priorities of CFDA 2017 Reform Related to Medical Device, MedTech, IVD

    In a press conference held earlier this year by CFDA, the agency declared that it would be pursuing its reform of the drug and medical device approval system […]