October 19, 2017
china medical device classification

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 19, 2017

China Brain Project Expected to Publish at 2017 Year End

China Brain Project to Focus on Brain Science and Research as Part of 13th Five-Year Plan Brain science has become a hot topic in global scientific research in recent years. […]
October 18, 2017

Shanghai To Test Medical Device Registrant System

Breaking news 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 registrant […]
October 18, 2017

IVD In China and Asia – Challenges And Opportunities

IVD companies from worldwide are working hard to enter and expand in the fast-growing China and other Asian markets. This includes some novel approaches. We have seen product development, market […]
October 16, 2017

China’s Intelligent Healthcare and Medical Device Segment Is Stepping Into A Rapid Development Period

“China Internet of Things Development Annual Report 2016-2017″ was released recently. According to “Annual Report”, Global Mobile Communications System Association forecasts that China’s healthcare & medical device will step into […]
October 12, 2017

China Launched a Nationwide Campaign to Protect IP of Overseas Companies

A dozen branches and agencies of the Chinese central government have launched a cohesive effort to protect intellectual property (IP) of overseas companies and organizations. This campaign is being participated […]
October 11, 2017

Chinese Investors Are Betting AI In Medical Technology

A US-based medical artificial intelligence startup VoxelCloud has just a closed US$15 million in Series A round, led by Chinese Internet giant Tencent Holdings Ltd together with named US investors including […]
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 […]
October 6, 2017

China’s Weigao Acquires Argon Medical Devices

Shandong Weigao Group from China filed to pay US$850 million for Argon Medical Devices, to expand its product line in China as well as expanding its growth outside the country. […]