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Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)

Ronen E

Problem Solver
Staff member
Super Moderator
From that webpage:
Respondents supported aligning the classification levels with either the EU Medical Device Regulation, or the classification principles of the International Medical Device Regulators Forum (IMDRF). It should be noted that these two frameworks are harmonised.
(Emphasis added)

A question to SW regulatory oversight experts: Are the guidelines / interpretations of these two frameworks, related to SW (classification or otherwise), indeed harmonised, considering the most recently released guidance documents? TIA for any response.
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