The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, put out a statement to finalize the process of feedback and received comments from industry representatives regarding public consultations on the scope of regulated software-based products. The authority also published a summary document highlighting all the submissions received from various entities involved in operations with medical devices, including medical device manufacturers (developers), healthcare institutions, professional associations, and research centers.


Scope of Regulated Software-Based Products

The TGA states that the initial consultation had been arranged due to numerous clarification requests filed by industry representatives requiring the authority to provide additional information for software-based products and the particular way it should be applied when placing medical software on the Australian market. The parties involved in medical device operations were interested in the boundaries for regulation and the appropriate exemptions and exclusions implemented in order to avoid an unnecessary regulatory burden.

The authority suggested indicating any cases where the risks associated with the use of software-based products is actually lower than required to create grounds for reasonable regulatory measures, or when the alternative regulatory approach could be applied. In order to provide a wider overview, the TGA also provided a description and comparison of the regulatory frameworks for software-based medical devices implemented in various countries,   including ones with a developed and efficient approach to medical software. This information has been added to the initial consultation to provide examples of regulatory measures and procedures that could be used.

The public consultation regarding software-based medical devices was closed on May 13, 2020. As a result, the TGA received 48 submissions from various industry representatives. The authority has already processed all the submissions and published its summary.

Summary on Medical Software

According to the information provided by the TGA, most of the industry representatives were in favour of further simplifications of regulatory procedures and easing the regulatory burden when suitable due to the low risk associated with the type of medical devices in question. In particular, the parties involved in operations with medical software suggested certain amendments and improvements be made to make the existing regulatory framework more efficient. It was also requested to provide additional clarifications regarding the terms and definitions. At the same time, it was stated that medical software products that could have a significant impact on public health should not be subject to simplified procedures in order to ensure the highest level of patients’ health protection and compliance with the applicable safety standards. Thus, it was confirmed that the safety and effectiveness of medical software placed on the Australian market should be assessed and confirmed.

The parties participating in consultations also provided the TGA with certain comments and suggestions regarding medical software intended to be used by end-users. They emphasized that in such cases, additional attention should be paid to important aspects such as personal data protection, cybersecurity issues, potential vulnerabilities, and also the risks associated with the low IT literacy of non-professional users.

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Feedback from the Medical Software Industry Association

One of the most exhaustive responses was provided by the Medical Software Industry Association (MSIA). The document covers the most important points related to significant risks associated with medical software. The MSIA also provided suggestions regarding potential ways to improve existing regulatory procedures to ensure safety and efficiency while creating favorable conditions for the development of innovative products. As it is stated in the MSIA submission, it is important for the TGA to create a balanced approach to medical software regulation.

When the MSIA provided feedback regarding the proposed regulatory approach to medical software described by the TGA in its consultation paper, they made sure to highlight the following aspects:

  1. Average users are not experienced and properly trained which can lead to a significant number of adverse events related to the TGA-approved software. To mitigate such risks, it is important to take this aspect into consideration when developing the medical software itself, and also the instructions for use accompanying the software when supplied to end-users.
  2. When making their software compliant with the general regulation and exclusion rules,   the medical software manufacturers   (developers)   could remove some important features and functions in order to avoid the necessity of passing the appropriate registration procedure required to include the medical software in the Australian Register for Therapeutic Goods (ARTG, the national register of TGA-approved medicinal products).   This could impact the overall quality and effectiveness of medical software available on the Australian market.
  3. The most innovative software could be subject to additional regulatory burdens due to the imperfection of the existing framework. This could mostly impact medical software utilizing such technologies like AI and machine learning by creating additional barriers.
  4. The lower regulatory burden in other countries could place foreign medical software developers in favorable conditions since they would have lower compliance-related time and cost expenses. At the same time, the implementation of international standards and an approach to the medical software regulation would create equal conditions for all parties involved in medical software development.
  5. Healthcare professionals, as the most qualified medical software users, should be provided with a wider scope of discretionary rights to select a particular software for use. The MSIA states that if the sphere is over-regulated, there could be a negative impact on the availability of medical software to the patients.
  6. Standardization could play an important role in the further improvement of medical software regulations and the creation of a transparent and clear regulatory framework that software developers could benefit from.
  7. It is important to consider an approach to regulation implemented in foreign countries concerning medical software-based products, to create an efficient framework beneficial for both patients and medical software developers.

Feedback from the Medical Technology Association

Additional feedback was provided by the Medical Technology Association of Australia (MTAA). The Association supported a regulatory approach based on the exclusion of medical software that could not be determined as a medical device, from the scope of regulation by the TGA. The main points covered by the MTAA submission included:

  1. If the software-based medical device does not create a significant risk for patients’ health, such software could be subject to exemptions. However, the manufacturers should still maintain compliance with essential principles regarding safety and efficiency and also report adverse events associated with the software.
  2. Some types of medical software should be excluded from regulation, providing that they are not required to be included in the   ARTG, assessed by the TGA, or monitored.
  3. It is important to ensure that the approach used to regulate medical software complies with the general principles adopted in other countries to avoid cases when the particular software is excluded or exempted from regulation in other countries, but subject to regulation as a medical device in Australia.

Summarising the information collected through public consultations, the TGA stated that feedback and suggestions received from industry representatives would be taken into consideration by the authority for the purpose of further improvement of the regulatory framework.

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