CFDA Updates

October 10, 2017

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

China Approves the Rega™ Line of Pacemakers CFDA said YES to the Rega™ line of pacemakers, China’s first domestically manufactured pacemakers that meet international standards. This product is manufactured in […]
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 30, 2017

Shanghai To Test Medical Device Registrant System

Breaking News from the signing ceremony for strategic cooperation between Shanghai CFDA and Pudong District government: Shanghai will be the first pilot to experiment medical device registrant system. Medical device […]