A Critical Review of Australia's Regulatory Oversight for New Generation Personalised Medical Devices.

Format:

Book

Author/Creator:

Grewal, Aman.

Language:

English

Subjects (All):

Precision medicine.

Medical instruments and apparatus industry.

Physical Description:

1 online resource (206 pages)

Edition:

1st ed.

Place of Publication:

Bradford : Ethics International Press Limited, 2024.

Summary:

Australia's medical device regulator Therapeutic Goods Administration (TGA) generally uses the term personalised medical device to describe medical devices made available to address specific individual requirements. 2019 Regulatory amendments including new definitions for personalised medical devices involved the subdivision of personalised medical devices into three categories of custom-made medical devices, patient-matched medical devices and adaptable medical devices, and the adaptation of the International Medical Device Regulatory Forum's (IMDRF's) definitions for personalised medical devices.This book highlights inadequacies and oversights in the current regulatory regime, and explores possible solutions to address them. The study focuses on the regulatory control of personalised medical devices in Australia, but elements of the proposed regime are also compared with similar elements within the United States and South Korean medical device regulatory frameworks. The book also explores some technically complex medical and legal principles and issues that arise and interact with each other in the application of personalised medical devices. It concludes with specific observations and recommendations aimed at improving the current Australian regulatory framework for new-generation personalised medical devices. This study also examines the benefits and drawbacks of the IMDRF-led regulatory reforms in various international jurisdictions. The IMDRF is spearheading medical device international regulatory alignment; therefore, the scope and significance of the information discussed is important in international jurisdictions. This detailed study is a key reference work for academic researchers, medical device manufacturers and sponsors, and legal and regulatory experts.

Contents:

Intro

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List of Charts

Preface

Introduction and Context

1.1 Introduction

1.2 Some Background Information

1.3 Contemporary Systematic Regulatory Problems

1.4 Specific Topics Targeted

1.5 New Regulatory Environment

1.6 This Book Intends to Do the Following

Pre-Existing Australian Regulation

2.1 Introduction

2.2 Definition of Therapeutic Goods

2.3 Personalised Medicine Regulatory Provisions

2.4 Specifics and Interdisciplinary Nature of the Regulatory Provisions

2.5 Concluding Remarks

2019 Proposed Regulatory Scheme in Australia

3.1 Introduction

3.2 Input by Stakeholders.

3.3 Specific Regulatory Proposals

3.4 Concluding Remarks

Medical Devices Regulatory Amendments Analysis

4.1 Introduction

4.2 The TGA's Regulatory Approach

4.3 2019 Regulatory Amendments Measures No 1

4.4 New Definitions for Personalised Medical Devices

4.5 Requirements for Supplying Custom-Made Medical Devices

4.6 Introduction of Medical Device Production System (MDPS)

4.7 Classification Rule for Medical Devices Recording Diagnostic Images

4.8 Medical Devices with Human Origin Component Regulated as Medical Devices with Biological Component

4.9 Personalisation of an Already Supplied Medical Device

4.10 Concluding Remarks

2019 Amendments Comparative Analysis

5.1 Introduction

5.2 The United States Food and Drug Administration

5.3 The Ministry of Food and Drug Safety South Korea

5.4 Concluding Remarks

Conclusion

6.1 Introduction

6.2 Researching Medical Device Regulatory Framework

6.3 2019 Regulatory Amendments

6.4 Overall Concluding Observations

Bibliography.

Notes:

Description based on publisher supplied metadata and other sources.

Part of the metadata in this record was created by AI, based on the text of the resource.

ISBN:

9781804417294

1804417297

OCLC:

1474241893