China Releases New Draft Regulations for Medical Devices

China’s Ministry of Justice is seeking comments on revisions to its medical device regulations that will significantly change the environment for devicemakers.

The June 25 draft amendment updated a previous amendment issued in October by the former China Food and Drug Administration — now the National Drug Administration of China (CNDA). 

Several of the regulatory reforms from the October draft were included, such as providing for compassionate use of devices that treat life-threatening diseases as well as conditional approvals for similar devices, according to Ropes & Gray attorney Katherine Wang.