7 Mar | CHICC Expert Workshop – A Guide to Regulation for Digital & Digitally Enabled Medical Technologies

Register now for our next workshop on the regulation of digital and digitally-enabled medical technologies in Australia, followed by networking.

From medical devices to software in a medical device and software as a medical device, alongside rapidly emerging technologies such as AI/ML, finding the right pathway to regulatory approval, and knowing which claims you can and cannot make, are critical hurdles to be overcome in your commercialisation journey.

This interactive workshop will be facilitated by Amabel Tan, ANDHealth Program Director and ANDHealth SAMD Industry Outreach Lead, and will bring together representatives of the Therapeutic Goods Administration and regulatory experts with proven expertise in supporting companies to navigate these pathways, both in Australia and in key markets across the USA & Europe.

Attendees will also have the opportunity to hear from leaders of SMEs which have successfully navigated regulatory processes in Australia and overseas, providing case studies to demonstrate the impact on their commercialisation journey in an interactive panel and Q&A session.

Key learning outcomes of this workshop:

• Increased knowledge of the regulatory environment for digital and digitally enabled medical technologies in Australia and in key overseas markets;
• Clarity on the regulatory pathway for participant technologies through observing worked examples and decision trees; and
• Understanding of the opportunities and challenges experienced by more established SMEs in securing regulatory approvals in key markets.