CFDA Updates

October 19, 2017

China to Speed Up Approvals Of New Drugs and Medical Devices By Accepting Overseas Trial Data

China is looking.. to speed up approvals for new drugs and devices and plans to accept data from clinical trials carried out overseas, a potential huge benefit  for both international […]
October 10, 2017

CFDA Gives Approval To China’s First Domestically Produced Pacemaker By a China-Overseas Joint Venture

CFDA said YES to the RegaTM line of pacemakers, China’s first domestically manufactured pacemakers that meet international standards. This product is manufactured in China by MicroPort Sorin Cardiac Rhythm Management […]
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 […]