Blogs

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 18, 2017

China Determined to Become A Leader In Life Science Innovation

A recent article published by Forbes finds that China’s recent life science policy announcements suggest that the best science and strongest most innovative companies – regardless of country of origin […]
July 17, 2017

Market Movers: BGI’s Upcoming $250 Million China IPO

BGI Genomics is planning for its IPO in China. As the contract sequencing and diagnostics divisions of China’s genomic company BGI, BGI Genomics expects to raise $250 million from this […]
July 16, 2017

Sharks Are Helping Human to Fight Infections

According to CGTN report, a U.S. company Sharklet , recently acquired by Chinese medical device firm Peaceful Union, has come up with a product that could provide a real answer […]