Blogs

November 17, 2017

Guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug Innovation

On October 8th, China State Council released guidelines for Further Reform Registration Reviewing and Approval to encourage medical device/drug innovation for comments. The guidelines contain 36 provisions for 6 key […]
November 17, 2017

CFDA Released a New Notice about “The Related Work for Regulating the Medical Device Classification.”

On October 10th, the CFDA released a new notice about “The Related Work for Regulating the Medical Device Classification.” Here are the highlights: 1.     For new medical devices that have […]
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 […]