Need help navigating Australias Software as a Medical Device (SaMD) regulatory landscape?
Book a 1:1 meeting with ANDHealths TGA-trained staff to discuss general queries on SaMD regulations or on 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).
The ANDHealth team were very knowledgeable and provided our startup with very valuable insights on the software development roadmap, ensuring we comply with the TGA requirements as we progress. SaMD Office Hours attendee