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Brazil / Japan: Essential Safety and Effectiveness Requirements

Discussion in 'Other Medical Device Regulations World-Wide' started by MaxiFuer, Sep 15, 2019.

  1. MaxiFuer

    MaxiFuer New Member

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    Hello everybody,

    where are the essential safety and effectiveness requirements for medical devices defined in Brazil and Japan? Is it true that for Japan the guidance document GHTF/SG1/N68 is applicable?

    Thanks in advance!

    BR, Maxi
     
    MaxiFuer, Sep 15, 2019
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