A Critical Review of The Degree of Regulatory Oversight for New Generation Personalised Medical Devices

Project: HDR ProjectMasters by Research

Project Details

Description

Rapid technological developments outpacing existing regulatory frameworks continue to challenge traditional model of the healthcare industry. Findings of ‘Implant Files’ by the International Consortium of Investigative Journalists in 2018, International Medical Device Regulators Forum’s efforts in addressing cross jurisdictional regulatory challenges related to the personalised medical devices and the Therapeutic Goods Administration’s now delayed commencement of proposed medical device regulatory reforms highlight possible regulatory inadequacies in dealing with ongoing innovations in the health care industry.

This study will examine regulatory control of the personalised medical devices in Australia. The research will examine three specific aspects of the personalised medical devices from a legal perspective without getting into the realm of legislative drafting. These three aspects include the manufacturing process, the materials and the regulation. In examining the emerging and significant potential for 3-D printed devices, the research will also explore associated intellectual property rights that arise, such as the ownership of rights in 3D printed human body parts involving biological information.

The research will also provide a comparative analysis on the status of similar regulatory control in other developed jurisdictions where similar issues are arising, such as the United States (US) and the European Union (EU).

The research aims will be achieved through a basic understanding of the field of personalised medicine including exploration of the pre-existing Australian and international regulatory practices, exploration of upcoming technological advancements and relevant regulatory practices followed by a critical review of the regulatory frameworks and recommendations to optimise the regulatory mechanisms. The thesis will include six chapters and the study will incorporate doctrinal research methodology with components of the applied research.

This study will attempt to contribute towards the evolution of a safe, optimal, balanced and almost future proof medical device regulatory system in Australia.
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