AMA submission to the Therapeutic Goods Administration – scope of regulated software-based products

The AMA in this submission advises the TGA to maintain a clear logic so that if clinical decision support software meets the  definition  of  medical  device it  remains  subject  to TGA regulation. This cautious approach acknowledges  the  rapidly  evolving  medical device software  industry and helps future-proof against a software device exemption that maybe defensible today but becomes problematic in the future.

In principle, the AMA does not support the use of exclusion powers in the TGA Act for software based medical devices that fit the legislated definition of medical device. TGA powers to require manufacturers to demonstrate compliance with Essential Principles including software efficacy and  accuracy  pre-market  are  central  to  patient  safety. As  are  the  TGA  requirements  for  post market  monitoring,  adverse  event  reporting,  public  alerts  and  if  necessary,  software  device recall. In AMA’s view there are very few  existing software-based  devices  suitable  for exemption. Exemptions due  to regulatory  overlap  with  alternative accreditation/regulation frameworks must be  assessed  case  by  case.

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