The article provides an overview of the existing regulatory framework for software-based medical devices.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in healthcare products, has published guidelines on the regulatory status of software-based medical devices. The document describes in detail the approach to be applied with respect to the products subject to regulation as medical devices that incorporate software or are software themselves. The guidance provides additional verifications as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance with the applicable regulatory requirements At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the applicable regulations.
The authority acknowledges the increasing importance of software-based medical devices that are widely used nowadays. Depending on the nature of the product, a medical device could either contain software as a part of it or be software itself. Technological development makes it vitally important to ensure the regulatory approach the authority applies with respect to such products allows to establish a proper balance between facilitating further development and use of innovative medical devices and ensuring their safety and effectiveness when used for the intended purpose. As a part of this process, the existing regulatory framework requires certain changes and modifications in order to accommodate the arising needs.
Under the general rule, software-based medical devices are products subject to regulation by the TGA. According to the guidance, this category covers standalone software products, medical devices incorporating the software, and also mobile applications to the extent such products meet the definition of a medical device as set forth by the Therapeutic Goods Act 1989, apart from the cases when specific exclusions apply.
At the same time, it is important to mention that there are numerous apps that are merely used to provide information or manage a healthy lifestyle. Such tools are not subject to regulation by the TGA since they fall outside the scope of a medical device definition.
The present document is intended to assist medical device manufacturers (software developers) with interpreting and following the regulatory requirements set forth under the existing framework. At the same time, the authority encourages the parties involved to request case-specific professional advice in order to ensure the requirements are duly followed.
The scope of activities undertaken by the TGA with respect to medical devices includes both pre-market review and post-market monitoring, covering the entire product lifecycle. When it takes to the regulatory approach, the Australian authority follows the recommendations developed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authority in the sphere of medical devices.
Software-Based Devices: Key Points
First of all, the document provides additional clarifications regarding the software products covered by its scope and highlights the key points to be considered in this respect. For instance, it is stated that in vitro diagnostic (IVD) medical device software requires special treatment due to its nature.
When describing the regulatory approach, the authority refers to the two main concepts being “exclusion” and “exemption”. As explained by the TGA, exclusion means that the devices are completely unregulated by TGA, while exemption means that TGA retains some oversight for advertising adverse events and notification, registration of the devices subject to exemption is not required.
The guidance further describes in detail the concept of software as a medical device (SaMD) used to describe software operating on a particular platform, the purpose of which falls within the scope of a medical device definition. This category covers a wide range of products, such as computer programs or mobile applications used in the healthcare sphere. According to the guidance, a software product will be subject to regulation as a medical device in case it is initially intended to be used for:
- Diagnosis, prevention, monitoring, prediction, prognosis, or treatment of a disease, injury, or disability;
- Compensation for an injury or disability;
- Investigation of the anatomy or of a physiological process;
- Controlling conception.
It is important to mention that for the purpose of determination of the regulatory status of a product, the term “monitoring” refers to active monitoring, but not to reviewing the relevant records or any other way of indirect monitoring.
According to the guidance, sometimes SaMD could be an accessory to a medical device. In such cases, they will be subject to regulation as separate medical devices.
Apart from SaMD, the guidance also refers to SiMD, which stands for “software in a medical device.” This concept describes the software as an integral part of a medical device, vitally important for the latter to operate as intended. Under the general rule, such a product will be subject to regulation as part of the respective medical device. As described in the example provided by the TGA, this will apply in case of software embedded into a medical device and supplied as a part of it.
The document also distinguishes software that controls a medical device as a separate category of software-based products subject to regulation under the existing framework. This category covers the software products intended to control or adjust a medical device’s operations by being connected to it in any way. With regard to such products, the authority explains that the applicable class under the risk-based classification they will be subject to will be determined based on the class of a respective medical device.
In summary, the present TGA guidance provides an overview of the regulatory requirements applicable to software-based medical devices. The document also describes the approach to be followed by medical device manufacturers (software developers) interested in having their products placed in the country’s market.
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