TGA SaMD Regulation Navigation Support

About

This joint initiative between ANDHealth and the Therapeutic Goods Administration (TGA) provides regulation and registration support for digital medical software companies looking to commercialise new products that can help improve health outcomes for Australian patients.

The highly acclaimed program has so far benefited over 1,000 industry members through 25 sold-out workshops and 350 hours of 1:1 training, with companies saying the training program has increased their ability to navigate Software as a Medical Device (SaMD) registration and regulations for new digital health technologies.

The program supports understanding the scope of products that are subject to regulation and require listing on the Australian Register of Therapeutic Goods (ARTG), software as a medical device classification, compliance with regulatory requirements and post-market responsibilities for manufacturers and sponsors of SaMD through webinars and one-on-one meetings.

The new partnership includes 10 webinars for another 200-400 attendees and over 160 hours of direct one-to-one coaching for digital health businesses seeking to navigate Australia’s SaMD regulatory environment, supporting them to accelerate the commercialisation of their products.

As well as providing support for Australian digital health companies, this program is open to researchers, clinicians, international companies looking to export to Australia, and interested parties from industry.
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Software as a Medical Device Webinars

Join ANDHealth and expert speakers from the TGA at our regular SaMD webinars.

Hear an overview of the key changes in the updated SaMD regulations, and participate in a live Q&A session directly with the TGA.

These sessions are for all Australian digital health SMEs required to design and deliver robust clinical trials and evidence to support the safety and efficacy of their digital health products, as verified by the TGA.

Register for our upcoming webinar:
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1:1 Coaching – Office Hours

These one-on-one Office Hours sessions with TGA-trained ANDHealth staff provide an opportunity to discuss general queries on the SaMD regulations, or navigating regulations for a specific software-based or digital health product or solution.

Potential topics include:
– The type of evidence required when seeking regulatory approval by the TGA.
– When regulatory approval is not required.
– How to list a device on the Australian Register of Therapeutic Goods (ARTG).

Please note that if you are already in active discussions with the TGA regarding a specific product, we recommend you continue discussions with the TGA directly through Digital.Devices@tga.gov.au.

Click here or fill out the form below to book your Office Hours session:
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Program Outcomes

1000+

Participants
supported

Sold-out
webinars

350

Office Hours
delivered

100%

of Office Hours
participants said the meeting increased their ability to navigate SaMD regulations

98%

of participants rated
their Office Hours meeting extremely valuable (72%)
or very valuable (26%)

94%

of webinar attendees
said the workshop increased their knowledge of SaMD regulations

Testimonials

The one-on-one meeting was invaluable to have the complex regulatory legislation presented, and delivered in simpler terms that any professional working within the digital health space can understand and apply to their individual work environments.

TGA SaMD Office Hours Attendee

I appreciate having access to timely and relevant information directly from the TGA, facilitated by ANDHealth. It's great to have the ability to ask questions directly and supported by ANDHealth Office Hours.

TGA SaMD Webinar Attendee

Our TGA guide was encyclopaedic in their knowledge (far better than Chat GPT!) and easily able to focus on the issues relevant to our regulatory pathway. Their interpretation of the intent and underlying measurements of the TGA and its regulators has been invaluable for our submission.

TGA SaMD Office Hours Attendee

This was an excellent event from ANDHealth and TGA with the opportunity to get all my questions answered and get clarity about a tricky subject.

TGA SaMD Webinar Attendee

About the TGA

The Therapeutic Goods Administration is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. It regulates medicines, medical devices and biologicals to help Australians stay healthy and safe.

Visit the TGA Website

TGA SaMD Regulation Navigation Support

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TGA SaMD Regulation
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