CFDA Updates

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 19, 2017

CFDA Updates: China Joins ICH

ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer. The International Council for Harmonisation […]
June 14, 2017

CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

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).