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China Insight - Lifesciences

New Measures Relating to the Registration of In Vitro Diagnostic Reagents

22/10/2014

The Measures related to the Administration of Registration of In Vitro Diagnostic Reagents (“Measures”) issued on 30 July 2014 by the China Food and Drug Administration (“CFDA”) entered into force on 1 October 2014. The Measures replace the Pilot Measures related to the Administration of Registration of In Vitro Diagnostic Reagents effective as of 1 June 2007 (“Pilot Measures”).

How will the new provisions impact the current practice of registration of In Vitro Diagnostic Reagents (“IVDs”), and more importantly, how will the new provisions affect the registration of IVDs for foreign companies?

Please access the Newsletter to read more.

Source
China Insight - Lifesciences
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Authors

Nicolas Zhu
Nicolas Zhu
Partner
Shanghai