December 14th 2017, China Food and Drug Administration (CFDA) issued the Announcement About Suspending The Import of The Calcium Sulfate and Artificial Bone Dust from UK Biocomposites.Ltd and also the Announcement About Suspending The Import of HER-2 detection kit( immunohistochemical method) Product from UK Leica Biosystems Newcastle Ltd.
Recently, CFDA conducted the oversea medical device manufacturing sites inspection. CFDA found the calcium sulfate and artificial bone dust from UK Biocomposites.Ltd registered separately in China, but sell in the composite package. Also the syringe and injection water in the package have not registered in China. There is no agreement with the registered products. It suspected of violating ‘Medical Device Supervision and Management Regulation’ and ‘Medical Device Registration Management Method’.
Also for the HER-2 detection kit, CFDA found the main raw material mice IgG and hydrogen peroxide supplier in the HER-2 detection kit( immunohistochemical method) Product from UK Leica Biosystems Newcastle Ltd have been changed and did not conduct the alteration based on the CFDA requirements. It suspected of violating ‘In Vitro Diagnostic Reagent(IVD Reagents) Registration Management Method’.
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