Blog

July 22, 2017

China Is Competing With US To Lead AI And That Affects The Medical Device Industry

In this year, there are signs that China is the close second to US and is getting head in some of the key AI areas. AI is now widely considered […]
July 20, 2017

China Is Now World’s Second Largest Market for Orthopedic Medical Devices

China has recently surpassed Japan as the second largest market for orthopedic medical devices in the world. With an aging population and improvement in health insurance policies, the demand for […]
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 […]
July 15, 2017

China & India Behind Fastest Growth of Biochips Market from Asia-Pacific Region

According to a recent report published by Orbis Research, the Asia-Pacific biochips market was worth $1.73 billion in 2016 and estimated to be growing at a CAGR of 22.94%, to […]
July 14, 2017

The Number of National Standard materials types for IVD increased from 61 to 93

In order to ensure the implementation of “Registration of IVD Reagents Administrative Decree”, National Institute Food and Drug Control (NIFDC), a national testing center authorized by CFDA, issued the third […]
July 14, 2017

The Best-Selling Medical Devices In China Are…

According to a 2016 report by US Government from its export data, the best selling medical devices in China are from these product categories: In vitro diagnostic (IVD) equipment 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. With the […]
July 11, 2017

International Manufacturers Playing An Important Role in China’s Fast Growing Medical Device Market

With economic development, aging population and people’s awareness of healthcare continues to increase, the global medical device market demand continues to grow rapidly. The medical device industry is the world’s […]