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Regulatory Affairs Medtech
China issues interim provisions on device recalls
22 June 2011
Vibha Sharma

China's State Food and Drug Administration has promulgated interim provisions relating to its management of the medical device recall process1,2. The new provisions, comprising six chapters and 38 articles, are due to come into effect on 1 July.

The provisions aim to ensure that the device recall system remains compliant with the SFDA's overall supervision of the medtech sector and that it meets international conventions on core issues...

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