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Updated Rules on Registration of Medical Devices – More stringent requirements for foreign medical device companies

China Insight - Lifesciences

20/10/2014

As a consequence of the introduction of the new Regulation on the Supervision and Administration of Medical Devices (“New Regulation”), effective since 1 June 2014, the China Food and Drug Administration (“CFDA”) has revised and promulgated a series of administrative measures to implement the provisions contained in the New Regulation. One of these measures, the Measures related to the Administration of Registration and Filing of Medical Devices (“Updated Registration Measures”) entered into force on 1 October 2014, replacing the Measures related to the Administration of Registration of Medical Devices (“Old Registration Measures”).

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Source
China Insight - Lifesciences
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Authors

Nicolas Zhu
Nicolas Zhu
Partner
Shanghai
Lingyun Rao
Lingyun Rao, LL.M.