The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a questions-and-answers document addressing the most important aspects related to software-based medical devices. The document is intended to assist medical device manufacturers (software developers) interested in placing their products on the country’s market in ensuring compliance with the applicable regulatory requirements.
Under the general rule, software-based medical devices are subject to regulation under the Therapeutic Goods (Medical Devices) Regulations 2002. Furthermore, all such products should be duly included in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of healthcare products supervised by the TGA. At the same time, some software products fall within the scope of applicable exclusions or exemptions. Thus, the regulatory approach to be applied to such devices should be different. The authority states that it is the sole responsibility of a medical device manufacturer (software developer) to determine the regulatory status of its product, and also whether it is subject to inclusion in the ARTG, or meets the respective exemption/exclusion criteria. Should the product in question fall within the scope of the appropriate exemption, registration would not be required. However, there could be additional conditions imposed for placing the product on the market. In certain cases, the product should be regulated by another authority, e.g., the Australian Competition and Consumer Commission.
To achieve and sustain compliance with the applicable regulatory requirements for software-based products, the authority encourages medical device manufacturers to familiarize themselves with the present FAQ, as well as other guidance documents issued by the TGA on the matter and related topics before asking for additional advice or clarification. However, it is still possible to contact the authority directly and request assistance with interpreting regulatory requirements. The TGA also refers to a guidance document describing the approach to be applied when determining whether the software is a software-based medical device. The authority additionally emphasizes that supplying software products that are falling within the scope of medical devices regulations without the appropriate registration is strictly prohibited, except the cases when such products meet a specific exemption or exclusion criteria.
Questions and Answers
The present FAQ issued by the TGA covers, inter alia, the following questions:
- Whether the software is subject to regulation by the TGA. As explained by the authority, the product should be regulated by the TGA in case it meets the definition of a software-based medical device, unless it falls within the scope of the appropriate exemption or exclusion. “Exclusion” applies in case the product should not be considered a software-based medical device, hence, should not be regulated by the TGA. However, as it was mentioned before, it could still be regulated by another authority. “Exemption” states for the situation when the product is a software-based medical device, but the respective regulations are not fully applicable. Instead, it only has to comply with TGA regulations on safety and performance, advertising, adverse events, and notification.
- Whether the software is a medical device. Depending on its intended use, functions, and features, the software could be considered a software-based medical device. Should it be the case, it should be subject to inclusion in the ARTG to be allowed for marking and use in the country.
- Intended purpose. The concept of intended purpose stands for (i) what [the] software’s core functions are; and (ii) what [the] software’s desired purpose or outcome is. Should it be determined that the product in question is a medical device, it would be necessary to provide a statement of the intended purpose, which would be later used when determining the class of the product under the applicable risk-based classification.
- Sponsor. Another important concept used when referring to a party responsible for a medical device is a sponsor. According to the guidance, a software “sponsor” stands for an individual or a legal entity performing at least one of such functions: exporting medical devices from or importing them to the country, manufacturing medical devices (developing software products), and also arranging for another party to import, export or manufacture (develop) a software-based medical device. It is further stated that a sponsor should reside/be incorporated in Australia. An entity that develops and supplies the software could be a developer and sponsor simultaneously. At the same time, a medical device manufacturer (software developer) is also allowed to cooperate with several sponsors engaged in distribution activities.
- Clinical practices. According to the document, “clinical practice” refers to when a software-based medical device is used, prescribed, or recommended by a health professional, irrespective of the way this was communicated to the user. The aspects to be taken into consideration in this respect include, the environment in which the product is intended to be used, and also its intended users (e.g., laypersons or health professionals).
- Manufacturer. The TGA explains that for regulatory purposes such terms as “medical device manufacturer”, “software manufacturer” and “software developer” could be considered interchangeable when used about an entity responsible for a medical device as its manufacturer. As it was mentioned before, a manufacturer may work with several sponsors (distributors) simultaneously.
- Classification. Should it be determined that the product in question is a software-based medical device, it would be also necessary to assign it to the appropriate class based on the risks associated with the product. Under the general rule, the risks should be analyzed in the context of the intended use of the product, as well as the severance of potential outcomes. The TGA also mentions that in the case the software-based medical device subject to review meets the applicable criteria of more than one class under the applicable risk-based classification, the one with the highest risk should be applied. The class of the product should be initially determined by its manufacturer. Moreover, the scope of documentation to be submitted when applying for inclusions in the ARTG would depend on the class of a medical device as well.
- Supplying medical devices are already included in the ARTG. According to the information provided by the authority, only a sponsor of a software-based medical device is allowed to supply it, even if it is already included in the register.
- Software development and regulation. The TGA explains that the testing and validation of the software should be completed in full before applying for inclusion in the ARTG. In case of changes to the software, it could be also necessary to notify the authority. Should such changes impact the applicable classification of the software, a new application has to be submitted under the respective regulatory requirements.
In summary, the present TGA guidance highlights the most important aspects related to software-based medical devices and their regulatory status. The document outlines the key points to be considered by medical device manufacturers (software developers) and other parties interested in marketing their products in Australia.
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