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.
On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.
The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)
Highlights of this revision:
1) Changed “Shelf Life” to “Shelf Validity Period”
2) Adjusted some wording
3) Modified the definition of implanted medical equipment, consistent with the definition in "Medical Device Classification Regulation" (CFDA, No. 15).