April 19, 2022
WTO

Brazil | Regularization of software as a medical device (Software as a Medical Device -SaMD).

Brazil South America

Medical Devices

This resolution contains provisions on the regularization of software as a medical device (Software as a Medical Device -SaMD).The Medical Devices Technical Dossier Structure is aligned with the document issued by the International Medical Device Regulators Forum -IMDRF/RPS WG/N9 (Edition 3)

Notified document (1)

Brazil | Regularization of software as a medical device (Software as a Medical Device -SaMD).

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Brazil | Regularization of software as a medical device (Software as a Medical Device -SaMD).

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