REGULATORY UPDATE | Australian Regulations on Software as a Medical Device (SaMD)

On 3 May 2022, the Australian Department of Health issued regulations regarding Software as a Medical Device (SaMD), which will be overseen by the Therapeutic Goods Administration (TGA). The TGA is a founding member of the International Medical Device Regulators Forum (IMDRF), a group that brings together medical device regulators from around the world to address current challenges in regulating medical devices. As software becomes increasingly integral to medical devices and broader digital adoption, it is also gaining recognition as an independent medical product. Notably, Australia does not regulate health applications that do not meet the definition of a medical device, even if many mobile applications provide only informational resources or tools for managing a healthy lifestyle.

Exceptions and Exemptions

Before supplying software in Australia, it is crucial to understand the legal requirements that may apply. Some software may be exempt from TGA regulations or still in the regulatory process. Exempt products are not required to be included in the Australian Register of Therapeutic Goods (ARTG). It is the responsibility of the supplier to determine whether their software falls under TGA regulations and whether it must be included in the ARTG before distribution in Australia. While exempt products do not need TGA registration, it is important to verify that the exclusion conditions are appropriate and to consider any other regulatory bodies that may have jurisdiction.

TGA Help Desk

To understand the requirements for legally operating in Australia, you can refer to the TGA guide and the Software-Based Medical Device FAQ. The TGA can be contacted via email at digital.devices@tga.gov.au or through the SME Assist service. SME Assist is a dedicated resource for small and medium-sized enterprises, researchers, and startups to help them navigate therapeutic goods regulations and understand their legislative obligations. You can also reach the TGA by phone at 1800 020 653.

Classification of Medical Device-Based Software

Medical device-based software is classified according to the potential level of harm it may pose to users or patients. The classification system includes four levels: Class I (low classification), Class IIa, Class IIb, and Class III (highest classification). This classification process is essential to determine the conformity assessment procedure that the manufacturer must follow for inclusion in the ARTG.

Supplying software-based medical devices in Australia without TGA registration and inclusion in the ARTG is illegal, unless an exemption or exclusion applies. A literature review may be conducted to assess the hazard risks associated with the software, considering articles and papers published over the past seven years that specifically address safety and efficacy.

Source: https://www.tga.gov.au/regulation-software-based-medical-devices#.YnDkv-oWJCk.linkedin