2 min read
The Software as a Medical Device (SaMD) sector in Australia is advancing quickly, fuelled by a commitment to high safety and quality standards from the Therapeutic Goods Administration (TGA). With a regulatory environment designed to support the safe introduction of digital health innovations, Australia has established a robust framework for SaMD, but navigating its requirements can be complex for manufacturers. Gaining access to the Australian SaMD market demands a keen understanding of TGA’s regulatory processes, submission pathways, and classification criteria.
To help manufacturers and industry stakeholders stay informed, Freyr is hosting a dedicated webinar, “Navigating SaMD Registration, Exempt Software, and Excluded Software under Australian TGA Regulations,” led by our regulatory expert, Bharath Rajendran. This session will cover the essentials of Australia’s regulatory framework for SaMD, sharing best practices for managing compliance and aligning with TGA’s guidelines.
Unpacking the Australian SaMD Regulatory Framework
Australia has crafted a regulatory landscape specific to Software as a Medical Device, distinct from traditional medical devices. As an evolving domain, SaMD encompasses software used for diagnostic, therapeutic, and monitoring purposes that directly impact patient care. With its detailed requirements, the TGA ensures that any SaMD introduced to the Australian market adheres to strict safety and efficacy standards, making regulatory compliance crucial.
Key Areas of Focus in the Webinar
The upcoming webinar will delve into critical aspects of Australia’s SaMD regulatory framework, including:
- Overview of TGA’s SaMD Framework
Gain a comprehensive understanding of TGA’s structure for regulating SaMD, along with the recent updates that impact the digital health industry in Australia. - Risk Classification
The TGA’s classification system for SaMD is a vital factor in compliance. The session will break down the classification criteria and explain how different SaMD types are regulated based on their risk to patient health. - Exempt and Excluded Software
Not all software falls under TGA’s SaMD regulations. Learn which types of software are exempt or excluded and understand the criteria to determine these classifications. - Submission Pathways and Requirements
Navigating submission processes is essential to accessing the market efficiently. Our expert will cover the requirements for pre-market submissions, data uploads, and audit processes. - Post-Market Obligations
Compliance doesn’t end at market entry. The TGA mandates ongoing obligations for SaMD manufacturers, such as regular reporting, risk management, and updating the software in line with regulatory expectations. - Future Trends: AI and Digital Health Technologies
As AI and machine learning reshape the digital health sector, regulatory frameworks evolve to address these advancements. We’ll explore the direction TGA may take to incorporate AI into the SaMD landscape.
Why Attend?
For SaMD manufacturers, this webinar is an opportunity to gain actionable insights into the TGA’s requirements and compliance essentials. With Australia’s SaMD regulations constantly evolving, companies must stay informed to remain competitive and meet the market’s stringent standards. This session will provide a roadmap for navigating the TGA’s regulatory landscape, from submission to post-market management, ensuring manufacturers are fully prepared to meet Australia’s SaMD requirements.
Register Today
Join Freyr’s expert-led webinar on December 11, 2024, and equip yourself with the knowledge needed to succeed in Australia’s SaMD market. Secure your spot and stay ahead of the curve in regulatory compliance for digital health innovation.
