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.
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 […]