Industry Urges Australia to Follow International SaMD Classifications

The proposal by Australia’s Therapeutic Goods Administration to align its regulation of software as a medical device with the EU’s approach drew general support from stakeholders, but some also urged the agency to look at approaches by the International Medical Device Regulators Forum, the FDA and Health Canada.

The agency proposes to classify software according to its potential to cause harm and to ensure that software products that are downloaded from overseas suppliers have an Australian sponsor who is responsible for the product in the Australian market.

Most comments supported aligning the classification levels with either the EU’s Medical Device Regulation or the classification principles of the International Medical Device Regulators Forum.