Recently, China Food and Drug Administration has organized an on-site inspection on imported medical devices and found that, the suppliers of the principal raw materials, mouse IgG and hydrogen peroxide, of the HER-2 Assay Kit (IHC) of Leica Biosystems Newcastle Ltdwere already changed, but no corresponding alteration was made in the registration, violating the relevant provisions of the Measures for the Administration of Registration of In-Vitro Diagnostic Reagents. To guarantee the safety of devices for public use and in accordance with the provisions in Article 55 of the Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the PRC No. 680), China Food and Drug Administration has decided to suspend the import of HER-2 Assay Kit (IHC) of Leica Biosystems Newcastle Ltd and organize the disposition by law since this very day.

It is hereby announced.

China Food and Drug Administration

December 11, 2017