Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650)

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China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”).

The State Council Legislative Affairs Office worked more than six years revising the predecessor of the New Regulation (the “Old Regulation”), which had been effective since 2000. The revisions are intended to establish a more efficient and scientific regulatory regime for supervision and administration of medical devices. The New Regulation addresses research and development, clinical trials, product approvals, manufacturing, business operations, sales, and advertising. Generally, the New Regulation moderates the oversight of low-risk medical devices and strengthens the supervision on high-risk devices. The New Regulation, summarized below, will have a significant impact on all medical device enterprises.

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Topics:  CFDA, China, Healthcare, Medical Devices

Published In: Health Updates, International Trade Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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