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Medical Devices / Regulatory Affairs

China Releases New Draft Regulations for Medical Devices

July 12, 2018
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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.

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