CFDA Updates

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 […]
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 […]