The Therapeutic Goods Administration in Australia is in charge of regulating health related software that falls under the statutory definition of a medical device, as defined in- “section 41BD of the Therapeutic Goods Act 1989 (Cth).”
Here is what you need to know:
- The regulation of software as a medical device is currently centred on a risk based approach.
- The current guidelines and regulations do not cater to the unique features of software as a medical device.
- The Therapeutic Goods Administration and the International Medical Device Regulators Forum are currently developing new and amended guidelines to better address the unique regulatory challenges posed by software as a medical device.
When is software a medical device?
Simply, software as a medical device is defined as any apparatus, instrument, appliance, or material that needs software to help alleviate disease via prevention, diagnosis, monitoring or treatment:
- Replacement, investigation of a physiological process or anatomy;
- Monitoring, diagnosis, treatment, or alleviation for a disability or injury
- Control of conception
In practice, this connotes that apps as well as software which provides information on managing a healthy lifestyle like tracking heart rate, or a daily step count is not considered a medical device. However, an app that assists patients in making a diagnosis or software that helps in processing X-ray images is considered a medical device and is regulated by the TGA.
Software as a Medical Device (SaMD)
Regulating Software as a Medical Device (SaMD) is challenging to say the least. The struggle to keep up with all the updated and new SaMDs and their ever changing regulations, as well as dealing with the current regulation of SaMDs is not getting easier but in fact is getting harder.
Basic facts you need to know about software as a medical device
“In accordance with the Guidelines, all SaMDs are required to be registered on the Australian Register of Therapeutic Goods. In order to be registered the following criteria must be met:
- Manufacturers of SaMD products must obtain a Conformity Assessment certificate, unless the SaMD is categorised in the lowest risk classification; and
- The SaMD must satisfy the TGA’s Essential Principles under the Therapeutic Goods Act 1989 (Cth) and the Guidelines.”
The TGA’s Essential Principles, are built to include all the requirements needed, in regards to the purpose, safety, design, transport and construction of medical devices.
If you are worried about your app and software usage and need clarification, the experts at Tego are at the ready to assist.
Tego offers Medical Indemnity Insurance for medical practitioners underwritten by Berkshire Hathaway, a brand globally synonymous with trust and integrity. We have a profound understanding of the Australian medical profession and the ever-changing healthcare industry. It’s this expertise that allows us to provide leading cover with more choice, innovation and greater flexibility. Contact us to find out more.
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This publication is general in nature and is not comprehensive or constitute legal or medical advice. You should seek legal, medical or other professional advice before relying on any content, and practice proper clinical decision making with regard to individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Tego Insurance Pty Ltd is not responsible to you or anyone else for any loss suffered in connection with the use of this information.
Eric is the CEO of Tego, an insurance agency offering specialist indemnity insurance solutions for the healthcare and life sciences sectors. His qualifications include a bachelor’s degree in business and law, a master’s degree from UNSW in law and management and an MBA from the AGSM.