CFDA Updates

November 22, 2017

CryoLife’s BioGlue® Clinical Trial Is Underway In China

CryoLife, a US-based medical device and tissue processing company focused on cardiac and vascular surgery, announced that enrollment has started in the company’s BioGlue clinical trial in China.  The results […]
November 22, 2017

BREAKING NEWS: CFDA Is Proposing 6 Major Changes to Its Medical Device Regulations

CFDA just released a Solicitation for Public Comments (SPC) for its proposed amendment of the Medical Device Regulations (MDR), as mandated by a recent order from the Chinese State Council. […]
November 17, 2017

BREAKING NEWS: CFDA Is Proposing 6 Major Changes to Its Medical Device Regulations

CFDA just released a Solicitation for Public Comments (SPC) for its proposed amendment of the Medical Device Regulations (MDR), as mandated by a recent order from the Chinese State Council. […]
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 […]