Transition Plan and Regulatory Changes for Software as Medical Devices
In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019. With the implementation date for the updated regulations just around the corner, 25 February 2021, manufacturers must be aware of the scope of these implications to legally introduce new devices and maintain existing ones on the Australian market. Detailed herein are the revised classifications with elaborative examples and considerations to ensure compliance with the regulations.
Immediate and Long-Term Considerations
The introduction of classification rules directly relevant to SaMDs, and the unique scope of risks they pose to patients, means that many SaMD products currently classed as low risk (Class I) will increase in classification to Class IIa, Class IIb, and Class III medical devices. Consequently, manufacturers may be required to confirm the classification of their product and in some cases, obtain Conformity Assessment certification to allow inclusion on the ARTG. It is important to note that certain software when intended to be used by a healthcare professional, may also now be regulated under a lower classification.
The transition period allows manufacturers continuous supply of their SaMDs under the current classification rules until 1 November 2024. To be eligible for the transition period, manufactures must notify the TGA before 25 August 2021. Note, this is only applicable to SaMDs entered on the ARTG before 25 February 2021 and impacted by the recent classification changes detailed in this blog post.
For SaMDs introduced after 25 February 2021, manufacturers must demonstrate compliance with the regulations per the new classifications.
Excluded Products and Exempt Medical Devices
Under the new amendments, certain software products will also now be excluded from any TGA regulatory requirements (not deemed medical devices) or exempt from ARTG entry.
The criteria for exempt devices are as follows:
- Consumer health products – prevention, management and follow up devices including wearable fitness trackers that do not provide specific treatment or treatment suggestions;
- Enabling technology – for telehealth, remote diagnosis, healthcare or dispensing;
- Digitisation – of paper-based or other published clinical rules or data including simple dose calculators and Electronic Patient Records;
- Analytics – population-based analytics that does not drive outcomes for individuals, including data analytics; and
- Laboratory Information Management Systems – including pathology and radiology use cases and software to automate workflows, integrate instruments, manage orders and samples and associated information (given these systems are already subject to oversight through other mechanisms).
Excluded products include:
- Software used for tracking health information for the self-management of eczema through analysis of images and user-entered data is an excluded software and is not considered to be a medical device. The software is intended to be used for self-management of an existing condition that is not a serious disease without providing specific treatments or suggestions.
- A consumer health and wellness product, such as a heart rate fitness tracker, not intended to manage serious conditions.
- Coaching and behavioural change software.
- Patient record outcome measures and quality of life assessment platforms.
A serious disease or condition is defined as one that:
- Requires consulting a healthcare professional for diagnosis and treatment.
- May cause death or long-term disability.
- May be incurable or necessitate significant therapeutic intervention.
- May pose risk to public health.
Some manufacturers who currently hold Class I ARTGs for SaMD may qualify for the exclusion criteria from 25 February 2021 onwards. To eliminate inefficiencies, it may be beneficial and cost-effective for manufacturers to review if their devices may be excluded.
In addition, the classifications introduce clinical decision support software (CDSS) which may be an exempt medical device, subject to a subset of the regulatory requirements, based on the device’s intended purpose and functionality.
Revised SaMD Classifications
The classification of SaMDs is risk-based depending on whether the diagnosis/screening is performed by the software or by a healthcare professional, the extent of risk the disease or condition poses to public health, and if the disease or condition is serious with immediate serious deterioration on the person’s health. Consequently, the Therapeutic Goods (Medical Devices) Regulations 2002 was updated to include the following classifications:
- Rule 4.5: Diagnosing and screening for a disease or condition
- Rule 4.6: Monitoring the state or progression of a disease, condition, etc.
- Rule 4.7: Specifying or recommending a treatment
- Rule 4.8: Providing therapy (via provision of information)
For manufacturers to smoothly transition to the new classifications, the TGA published two guidance documents in January and February 2021. Manufacturers should adopt a transition plan to ensure they are compliant with these regulations and continue to meet their obligations.
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