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

On 3 May 2022 the Australian Department of Health issued a regulation on Software as a Medical Device (SaMD) which will be regulated by the Therapeutic Goods Administration (TGA). TGA is a founding member of the International Medical Device Regulators Forum (IMDRF) A group of medical device regulators from around the world who meet regularly to address the current challenges of regulating medical devices. Software is becoming increasingly important in medical devices and, in a broader sense, digital adoption. It is also becoming more important as an independent medical product. There are many mobile applications that only provide a source of information, or tools to manage a healthy lifestyle, Australia does not regulate health applications that do not meet the definition of a medical device.

Exceptions and Exceptions

There are several things that must be done legally before supplying software in Australia. Some software may be exempt from TGA regulations or still in the process of being regulated by TGA. However, software that is exempt or still in the regulatory process will be exempt from the requirement to include the product in the ARTG. It is your responsibility to find out if your software is under TGA regulations and whether the product must be included in the ARTG before being supplied in Australia, excluded and the exception applies to your product. Exempted products do not need to be registered with the TGA but need to be checked whether the exclusion conditions are appropriate and take into account what other regulatory bodies may regulate

TGA Help Desk

To understand what you need to do to legally operate in Australia, you can read the TGA guide and Software-Based medical device FAQ. TGA can be contacted via email digital.devices@tga.gov.au‎ or through a special service for small and medium-sized enterprises, namely SME Assist. SME Assist is a dedicated service belonging to TGA that is offered to small and medium sized entrepreneurs, researchers, start-ups to help those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations. Or you can contact him by telephone 1800 020 653.

CLASSIFICATION OF Medical Device-Based Software

Medical device-based software also has a classification, the classification carried out for medical device-based software is classified according to the level of harm it may pose to users or patients, the higher the classification level, the higher the level of regulatory oversight. This classification of medical device-based software has four levels. Class I (low classification), class IIa, class IIb and class III for the highest. Classification is carried out before an application is made to determine the conformity assessment procedure to be determined by the manufacturer and for inclusion of the device in the Australian Register of Therapeutic Goods (ARTG).

When you supply software based medical devices in Australia and are not registered with the TGA and are included in the Australian Register of Therapeutic Goods‎‎ (ARTG) it will be illegal. Unless the product is an exemption or exclusion applies. ‎A quick literature review is carried out to understand the software hazard risks. The review considers articles and papers published over the last seven years that specifically address safety and efficacy.

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