CFDA Updates

October 6, 2017

CFDA Issued 7 New Technical Review Guidelines

CFDA has issued 7 new guidelines from September 13rd to September 21st. Even though they are called guidelines, once they are released, you are expected to comply with them whether your […]
October 6, 2017

Beijing Provincial CFDA Announced a Notice of “Strengthen the Supervision and Inspection of Import Medical Device Distributors”

On September 11th, 2017, Beijing provincial CFDA announced a notice of “Strengthen the Supervision and Inspection of Import Medical Device Distributors”. 1.      Objectives: ·       Understand the operation quality control status […]
October 6, 2017

Beijing CFDA Issued “Guideline for IVD Production Quality System Key Inspection Areas (Draft)” for Comments

On September 18th, Beijing CFDA issued “Guideline for IVD Production Quality System Key Inspection Areas (Draft)” for comments. This guideline is the revised version for “Guideline for IVD Production Quality […]
September 22, 2017

Trendlines And China’s Haier To Collaborate In Medtech Startups

The Trendlines Group. an Israel-based, Singapore-listed incubator of medical and agricultural technology startups – has extended its partnership network with China’s Haier. Recently, Trendlines partnered with China’s Haier Hai Chuanghui […]
September 13, 2017

CFDA Released 8 Medical Device Industry Standards and a Modification, Including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General Requirements”

CFDA Release Recently, CFDA released 8 medical device industry standards and a modification including the “Intravascular Catheter and Disposable Sterile Catheter, Part 1: General requirements” and YY 0669-2008, the first […]