Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Director KD&A Balgowlah Heights, New South Wales, Australia
Description: When a medical device does not fully meet the requirements of the Therapeutic Goods (Medical Devices) Regulations, sponsors and manufacturers must carefully evaluate the available regulatory pathways. One of the most frequently discussed, but often misunderstood, options is the consent mechanism. This discussion will clarify when consent may be appropriate, what it entails, and what alternative routes exist for achieving or maintaining market access in Australia.
Participants will walk away with a deep knowledge of the regulations, but also practical tools for assessing whether consent is the right strategy in specific scenarios and how to communicate these options effectively within their organisations. Case-based discussions will highlight how to weigh regulatory risk, balance commercial pressures, and anticipate regulator expectations.
By the end of the solutions circle, attendees will be better equipped to advise their teams on viable pathways for non-compliant devices, contribute more confidently to regulatory strategy discussions, and safeguard both compliance and patient access. This will not only strengthen their technical expertise but also enhance their role as trusted advisors, enabling them to influence decision-making and career progression in the complex Australian regulatory environment.
Learning Objectives:
Upon completion, participants will be able to explain the regulatory basis of the consent mechanism in Australia and describe when it may be applied to non-compliant devices.
Upon completion, participants will be able to evaluate scenarios involving non-compliant devices and determine whether consent or alternative regulatory pathways are the most appropriate option.
Upon completion, participants will be able to apply decision-making strategies to advise their organisations on managing regulatory risk, ensuring compliance while supporting timely market access.
