CFDA Updates

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 […]
September 11, 2017

CFDA Update: iCAD’s Xoft Axxent Balloon Applicators Approved for Early-Stage Breast Cancer

CFDA UPDATE CFDA Update: CFDA has approved iCAD Inc.’s Xoft Axxent balloon applicators for the treatment of early-stage breast cancer. This approval makes the complete suite of Xoft System products […]