Blogs

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 in 2017 […]
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 implantation […]