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

8 November 2019

The TGA thanks respondents who provided a submission in response to the public consultation paper, Regulation of software, including Software as a Medical Device (SaMD).

This consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework including in respect of the classification of medical devices.

A total of forty-one (41) submissions were received.

TGA summary

Software is regulated by the TGA under the existing medical device framework; however, advances in technology, including the emergence of 'apps', are not adequately covered in the current scheme.

This consultation focused on proposed regulatory reforms that include introducing rules to classify software according to its potential to cause harm through the provision of incorrect information, ensuring that software products that are downloaded from overseas suppliers have an Australian sponsor who is responsible for the product in the Australian market, and clarifying the essential principles for safety and performance for medical devices that incorporate, or that are, software.

There was broad support for the three proposed reforms. 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. While there was support for the requirement for downloaded software to have an Australian sponsor, it was noted that this would be challenging to enforce, given the ease of digital downloads. Stakeholders were in favour of clarifying the essential principles for software to make pre-market requirements for software more transparent.

Some stakeholders did raise issues with the TGA's proposed changes to the framework for regulating medical devices software. These included concerns about the cost of compliance for products that may have their classification increased. Stakeholders also highlighted a lack of clarity on some issues, for example, whether pathology software will be affected, the requirements for artificial intelligence technologies and software services, how software is assessed by the TGA, and explicitly excluding some types of software products from regulation.

Post-consultation workshop

After analysing the feedback to the consultation paper, the TGA held a face-to-face workshop with stakeholders who had provided a submission to the consultation. The key outcomes of the workshop reinforced the consultation results for regulation to continue to be risk and principles based and internationally harmonised; there should be some Essential Principles specific to software; the cost of compliance may be difficult for small entities; the boundary for regulated software should be clear; and there may be some products that could or should be expressly excluded from regulation.

Next steps

The TGA has considered the feedback received from the consultation, the workshop and further targeted stakeholder engagements, and has undertaken to ensure that its proposals for reform reflect this input. In addition, the TGA is continuing its work in this area, especially the work on clearly defining the boundary between software products that are, are not, or should not be, included in the regulatory framework. Additional consultation will be conducted in 2020, including to recognise other complementary work that is occurring on mobile health apps, to produce policy options for the Government to consider.

Stakeholder engagement and production of guidance material will continue in support of the regulation of software. New material published since the workshop includes: Guidance documents on cybersecurity of medical devices for industry, users and consumers; webinars on: The differences between Class I and Class IIa regulatory requirements; Applying the Essential Principles to software and Cybersecurity of Medical Devices; and conference presentations on Software regulation and Clinical evidence for software.

Submissions received

All submissions that were not marked as confidential are now available in PDF format.


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