1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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

    Sep 15, 2019
    Likes Received:
    Trophy Points:
    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