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China Insight - Lifesciences

Medical devices: new rules and uncertainties


The revised “Regulation on the Supervision and Administration of Medical Devices” (hereinafter referred to as the “New Regulation”) (enacted by the State Council of PRC on 7 March 2014) entered into force on 1 June 2014. The New Regulation replaces the former regulation enacted on 4 January 2000 (hereinafter referred to as the “Former Regulation”).

Although the New Regulation has lessened the requirements medical devices distributors of class I medical devices must fulfill in order to enter into the medical device industry, it has imposed further potential liability in the form of additional sanctions. Medical device companies should check carefully that all compliance criteria have been fulfilled. It can be expected that after the New Regulation comes in to force, the food and drug authorities will be visiting medical device companies more often to inspect their operations.

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China Insight - Lifesciences
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Nicolas Zhu
Nicolas Zhu