China Insight - Lifesciences
Medical Device Manufacturers Risk Facing New Unannounced Inspections
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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