China In­sight - Lifes­ci­ences

Med­ic­al Device Man­u­fac­tur­ers Risk Fa­cing New Un­an­nounced In­spec­tions

01/07/2012

On 18 June 2012, the State Food and Drug Administration (“SFDA”) issued new regulations entitled “Interim Working Procedure of Unannounced Inspections over Manufacturing Enterprises of Medical Devices” (“Procedure”). Being the first framework regulation governing unannounced inspections for medical device manufacturers, it will undoubtedly have an important impact on all companies producing medical devices.

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Source
China Insight - Lifesciences
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Authors

Nicolas Zhu
Nicolas Zhu
Partner
Shanghai