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Regulatory Focus™ > News Articles > Changes to Medical Device Law Clear China’s State Council

Changes to Medical Device Law Clear China’s State Council

Posted 14 February 2014 | By Louise Zornoza

China's State Council Executive Committee cleared a Revised Medical Devices Bill on 12 February 2014 that modernizes China's current device law, which was first implemented more than a decade ago.

The changes include adjustments to the definition of medical devices and device classification rules; additional measures for monitoring the quality of medical device production and risk monitoring; new medical device adverse event monitoring, including traceability and recall systems; and increased penalties for violations of the law and regulations. 

The process to revamp medical device regulation began in 2006 under the former State Food and Drug Administration (SFDA), which submitted the proposed revisions in 2008 to the State Council Legislative Affairs Office for its review and further modification.


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