The new classification rules for software-based medical devices (“SaMDs”) and personalised medical devices introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 commences this week.

What is the new regime?

From 25 February 2021, the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) introduced by the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 (Cth) (“Amendment Regs”) take effect.  Broadly, the Amendment Regs introduce new classification rules for SaMDs resulting in higher risk devices being re-classified to a higher class.

SaMDs (now defined as “active medical devices”) may be up-classified from a Class I device to a Class IIa device (or higher depending on the device’s risk) if the device is intended to be used: 

1. in relation to diagnosing or screening for a disease or condition;
2. for monitoring the state or progression of a disease or condition;
3. for specifying or recommending treatment or intervention; or
4. to provide therapy to a person through the provision of information that may cause harm to a person. 

The Essential Principles are also being amended to, amongst others, introduce cybersecurity, privacy/ data and lifecycle controls for SaMDs. Additional requirements include, for example:

1. ensuring the integrity and quality of data or information handled by the device is maintained; and
2. requiring SaMDs to be designed, produced and maintained with regard to best practice in relation to software, security and engineering to provide cybersecurity of the device such as minimising the risks associated with known cybersecurity vulnerabilities and protecting against unauthorised access, unauthorised influence or unauthorised manipulation.

These reforms arise following public consultation in early 2019 which identified the need to better address the classification of SaMDs in line with the European Medical Device Regulation and international best practice.

Regulatory changes to personalised and custom-made devices will also take effect on 25 February 2021. These changes narrow the category of devices exempt from registration onto the Australian Register of Therapeutic Goods (“ARTG”) and introduce new annual reporting requirements to the TGA.  Sponsors of custom-made devices will need to consider whether their products will have to start being included in the ARTG. 

Is my software a SaMD?

Whether your software will be classified as a SaMD largely depends on the manufacturer’s intended use of the product as described in the product’s instructions for use.

Not all health related software products will fall under the regulation of the TGA.  Examples of excluded therapeutic goods include (amongst others):[1]

1. electronic health record software intended to be used in clinical practice by healthcare providers to collect, use, disclose and otherwise manage patient clinical data within or between healthcare facilities but is not intended to be used to make a recommendation or decision about the treatment of a disease, condition, ailment or defect;
2. general health or wellness software (e.g. software that encourages behavioural change in weight, exercise, sun exposure or dietary intake) so long as the software is not intended to be used in clinical practice or for the purpose of diagnosis, prognosis, or making a decision about the treatment, of a disease, condition, ailment or defect;
3. software that solely provides alerts to health professionals (“HCP”) in relation to patient healthcare and is not intended to replace the clinical judgement of a HCP;
4. self-management software devices of non-serious disease, condition, ailment or defects that is not intended to be used in clinical practice;
5. certain digital mental health tools, including a cognitive behaviour therapy tools; or
6. software intended solely for the purpose of storing or transmitting patient images.  

Implications for sponsors and manufacturers

Registration of Class I devices do not require assessment by the TGA prior to registration and is therefore fairly straightforward.  The up-classification of SaMDs will require manufacturers to undergo conformity assessment prior to registration on the ARTG.  This means documents demonstrating the safety, quality and performance of a device will need to be prepared and provided to the TGA upfront.

For existing devices, transitional arrangements will apply to ensure sponsors can continue to supply their products while new applications are submitted to the TGA for inclusion into the ARTG under the new classification.

What’s next?

Due to the COVID-19 pandemic, the implementation of a number of medical device reforms have been delayed to commence on 25 November 2021.  This includes the re-classification rules of a number of medical devices such as active medical devices for therapy with diagnostic functions, active implantable medical devices, medical devices used in direct contact with the heart, central circulatory or central nervous systems and medical devices that administer medicines or biologicals by inhalation or consist of substances introduced into the body via a body orifice or applied to the skin.

Please contact us if you would like further information on how these changes may impact your business.

Authored by: Mandi Jacobson, Angell Zhang.