November 17, 2017

Technical Requirements for Accepting Oversea Clinical Trial Data (Draft)

On October 20th, CFDA released the new technical requirements for accepting overseas clinical data for comments. This technical requirement is based on the guidelines from Further Reform Registration Reviewing and […]
November 17, 2017

CFDA Released and Implemented the 3rd Batch of “Medical Device Clinical Trial Exemption List”.

On October 31st, the CFDA released and implemented the 3rd batch of “Medical Device Clinical Trial Exemption List”. There are 37 Class II, 11 Class III medical devices and 116 […]
November 17, 2017

CFDA Released 9 Technical Review Guidelines

On September 28th, CMDE issued 4 medical device technical review guidelines for comments 1.     Drug Eluting Coronary Stent System Preclinical Study Technical Review Guideline. 2.     Mobile Medical Device Registration Technical […]
November 7, 2017

China’s State Council: Official Opinions On Deepening the Review and Approval Policies Reform and Encouraging Drug And Medical Device Innovations

On October 8, in a government news conference in Beijing, the State Council issued the “Opinion on Encouraging the Innovation of Drugs and Medical Devices by Deepening the Reform of […]
November 6, 2017

About China Medical Device Market Entry

Current Regulatory Process and Reform Companies interested in entering the Chinese market for innovative medical devices and treatments must first overcome existing barriers to market access and navigate an uncertain […]