Blog

July 10, 2017

Maccura and Qiagen Formed a Joint Venture in China

China’s Maccura Biotechnology formed a joint venture with Qiagen of the Netherlands to develop and market Qiagen’s GeneReader NGS system in China. Maccura is a China IVD company. It will […]
July 10, 2017

China’s Largest Insurer Announces $1 Billion Fin-Tech/Healthcare VC Fund

China’s Ping An Insurance Group, its largest insurer by market value, announced a plan to launch a $1 billion international fund that will invest in fin-tech and healthcare startups. In […]
July 8, 2017

China Medical Device Market Development: Hebron and BioPromin Form $50m JV

China Medical Device Market News: China-based Hebron Technology Co Ltd and Ukrainian firm Research and Product Complex BioPromin Ltd (BioPromin) are investing up to $50 million for a joint venture […]
July 8, 2017

China Medical Device News: Tekni-Plex Invests In Medical Manufacturing in China

According to a press release, Tekni-Plex Inc. based in the US has announced a $15 million investment in a new state-of-the-art manufacturing facility in Suzhou, China. It represents the single […]
July 6, 2017

Epic Sciences Closed A $40 Million Series D Financing

Epic Sciences of San Diego closed a $40 million Series D financing led by Hong Kong’s Hermed Capital. Epic is developing a portfolio of blood-based tests that predict drug response […]
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

China and Other Emerging Medtech Markets Ready for Global Stage

A recent report released by Boston Consulting Group has highlighted that medical technology is expected to break out of the emerging markets and onto the global stage. The report references […]
July 3, 2017

CFDA Update: Protecting Medical Device Data Confidentiality in China

Among the most asked questions from medical device makers who are conducting business in China is how the CFDA guarantees that data stays private and safe. To help ease the […]
July 3, 2017

CFDA Update: New guidelines on Disposable Infusion Pump and Blood Storage Bag

CFDA has issued 2 new guidelines from June 17rd to June 20th. 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.   On June 20th, CFDA issued a technical review guideline on Disposable Infusion Pump (Non-electric Driven) for comments. 

It is class III with class code 6866.

The Disposable Infusion Pump (Non-electric Driven) is a medical device used in medical institutions. It injects drugs or biologics into the human body in a controlled pumping mechanism

This guideline does not apply to electric powered or electric-controlled infusion pumps, implanted drug infusion device, enteral nutrition infusion pump, percutaneous infusion devices. The guideline applies to the infusion devices that are controlled and powered by patients direct intervention instead of the devices that are powered and controlled by themselves.

June 29, 2017

CFDA Approves Novel Heart Valve Replacement Device

China’s Food and Drug Administration has approved a new-generation heart valve replacement product, which greatly reduces surgery time and increases survival rate.   The J-Valve, an upgraded transcatheter aortic valve […]
June 27, 2017

SpineGuard and XinRong Medical Group Sign Exclusive Distribution Agreement For PediGuard® in China

June 21, 2017 12:00 PM Eastern Daylight Time   SpineGuard an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, announced today an exclusive […]
June 27, 2017

China Market Report: China On The Way To Become The Largest Telehealth Market

According a market research published by iData, China, with its 1.4 billion inhabitants, is now expected to exceed the U.S. and Japan in the telemedicine market, and the main contributing […]