Medical Device Regulations

A Complete Guide

1st Edition - January 13, 2022
Imprint: Academic Press
Author: Aakash Deep
Language: English
eBook ISBN:
9 7 8 - 0 - 3 2 3 - 9 1 1 2 7 - 6

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers th… Read more

Purchase options

BLOOM INTO SPRING SAVINGS

Save up to 25% on books and eBooks!

Shop now

Institutional subscription on ScienceDirect

Request a sales quote

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety.

The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements.

Cover image
Title page
Table of Contents
Copyright
Preface
Chapter 1. Introduction of medical devices
Abstract
1.1 Introduction
1.2 Classifications of medical devices on the basis of risk
1.3 The basic design and manufacturing principles listed in this section apply to IVD and medical devices
1.4 History of medical device regulations globally
1.5 Product life cycle of medical device
1.6 The five stages of the medicinal product life cycle
1.7 International Medical Device Regulators Forum
1.8 IMDRF Management Committee
1.9 GHTF
1.10 Summary Technical Documentation
1.11 Global medical device nomenclature
1.12 Conclusion
References
Chapter 2. Ethics of clinical trials of medical devices
Abstract
2.1 Introduction
2.2 Clinical investigational plan for medical devices
2.3 Clinical investigation conduct
2.4 ISO 14155:2011
2.5 International Council on Harmonization Good Clinical Practice
2.6 International Council on Harmonization Good Clinical Practice principles
2.7 ISO 13485:2016: quality management system of medical devices requirements for regulatory purposes
2.8 General requirements of quality management system
2.9 ISO 14971:2019 medical device risk management applications
2.10 Risk management application throughout the lifecycle of the device
2.11 Conclusion
References
Chapter 3. Regulations for medical devices in the United States
Abstract
3.1 Introduction
3.2 US Food and Drug Administration
3.3 Classification of medical devices (I, II, and III)
3.4 Regulatory approval process for medical device
3.5 Premarket notification 510 (k)—21 CFR Part 807 E
3.6 Premarket approval
3.7 Approval process of medical devices in the USA: it follows some steps
3.8 Investigational device exemption
3.9 Quality system requirements 21 CFR part 820
3.10 Labeling requirements 21 CFR Part 801
3.11 Postmarketing surveillance of medical device
3.12 Unique device identification of medical device
3.13 Conclusion
References
Chapter 4. Regulations of medical devices in Europe
Abstract
4.1 Introduction
4.2 Classification of medical devices
4.3 Medical devices’ laws in Europe: there are three laws in EU are
4.4 The new approach for regulating products—key features
4.5 Regulatory approval process of medical device
4.6 Notified bodies in Europe
4.7 CE Marking in Europe for medical devices
4.8 Procedure
4.9 Documents required for medical device marketing approval
4.10 Labeling requirements
4.11 Medical device labeling: EU Regulation MDR 2017/745
4.12 Product labeling and QMS—EU MDR
4.13 Conclusion
References
Chapter 5. Regulations of medical devices in ASEAN countries
Abstract
5.1 Introduction
5.2 Members of the Association of Southeast Asian Nations
5.3 ASEAN Common Submission Dossier Template
5.4 Product registration on the basis of CSDT ASEAN
5.5 General criteria to register a medical device
5.6 ASEAN CSDT format
5.7 Registration process in ASEAN countries
5.8 Conclusion
References
Chapter 6. Regulations of medical devices in Japan and China
Abstract
6.1 Introduction of medical device in Japan
6.2 Regulatory authorities
6.3 Medical device classification
6.4 Regulatory approval process in Japan
6.5 Introduction of medical device in China
6.6 Regulatory authorities
6.7 Classification
6.8 Registration procedure
6.9 Labeling requirements
6.10 Challenges
6.11 Conclusion
References
Chapter 7. Regulations of medical devices in Canada
Abstract
7.1 Introduction
7.2 Definition of medical device
7.3 Action plan for medical devices from the Canadian Health Ministry
7.4 Classification of medical devices
7.5 Medical device premarket requirements in Canada
7.6 Canadian Medical Devices Conformity Assessment System
7.7 Application form for registration of medical device
7.8 Registration requirements
7.9 Note
7.10 Registration procedure
7.11 Medical Device License
7.12 Labeling requirements of medical device in Canada (Section 21)
7.13 Timeframe: the approval process varies by device class
7.14 Special requirements
7.15 Local fees
7.16 License validity
7.17 License transfer
7.18 Authorized representative/license holder
7.19 Conclusion
References
Chapter 8. Regulations of medical devices in India
Abstract
8.1 Introduction
8.2 Classification of medical device in India
8.3 Proposed classification system for medical devices
8.4 Regulations in India
8.5 Market of medical devices
8.6 CDSCO
8.7 Medical device definition as per CDSCO
8.8 Medical device registration process
8.9 The documents needed for registration
8.10 Approval process of medical device in India
8.11 Manufacture of medical devices for sale or for distribution
8.12 Import of medical devices
8.13 Inspection of foreign manufacturing facilities
8.14 A proposal to regulate medical devices in India
8.15 New proposed regulations for clinical trials
8.16 Reporting of medical devices in India
8.17 Labeling of medical devices
8.18 Recall of medical devices
8.19 Conclusion
References
Chapter 9. Regulations of medical devices in Australia
Abstract
9.1 Introduction
9.2 An overview of Australia’s medical devices regulatory authority
9.3 Definition of medical device as per TGA
9.4 Classification of medical device
9.5 Lifecycle approach to regulation
9.6 Postmarketing regulations
9.7 Medical device registration in Australia
9.8 Medical device regulatory system in Australia
9.9 Essential principal of medical devices in Australia
9.10 Declaration of Conformity
9.11 Overview of medical device regulations in Australia
9.12 Regulatory framework of medical device in Australia
9.13 Conformity assessment and ARTG inclusion
9.14 Templates Declaration of Conformity (medical devices)
9.15 Medical device inclusion process
9.16 Postmarket surveillance
9.17 Fees of medical devices in Australia
9.18 Conclusion
References
Chapter 10. Regulations of medical devices in Gulf Cooperation Council countries
Abstract
10.1 Introduction: Gulf Cooperation Council countries
10.2 Saudi Arabia
10.3 Saudi Food and Drug Authority
10.4 Medical device definition as per SFDA
10.5 Classification of medical devices in Saudi Arabia
10.6 Medical device regulations in Saudi Arabia
10.7 Required documents
10.8 Medical device technical documentation
10.9 Essential principles of medical devices
10.10 Supplying medical devices to the KSA market
10.11 Registration and listing requirements
10.12 Medical devices marketing authorization
10.13 The approval process for medical devices in Saudi Arabia
10.14 Timeframe
10.15 Special requirements
10.16 Local fees
10.17 License validity
10.18 License transfer
10.19 Authorized representative/license holder
10.20 Labeling requirements of medical devices ,
10.21 Postmarketing surveillance of medical device
10.22 Kuwait
10.23 Classification of medical device
10.24 Documents required for registration
10.25 Registration and regulations of medical devices in Kuwait
10.26 Timeframe
10.27 Special requirements
10.28 Local fees
10.29 License validity
10.30 License transfer
10.31 Authorized representative/license holder
10.32 Bahrain
10.33 Classification of medical device
10.34 Authorized representative registration
10.35 Registration of medical devices
10.36 Validity
10.37 Renewal
10.38 Qatar
10.39 Classification of medical device
10.40 Additional information
10.41 Oman
10.42 Classification of medical devices
10.43 Documents required for registration of medical device
10.44 Medical device regulations in Oman
10.45 Time period
10.46 License validity
10.47 Authorized representative
10.48 United Arab Emirates
10.49 Classification of medical device
10.50 Medical device registration and regulation procedure in UAE
10.51 Documents required for the registration: two registration required
10.52 Registration process flowchart
10.53 Timeframe
10.54 License validity
10.55 Authorized representative
10.56 Conclusion
References
Chapter 11. Regulations of medical devices in Sri Lanka
Abstract
11.1 Introduction
11.2 Scope and responsibilities of the NMRA for the approval of medical devices
11.3 Medical device definition as per NMRA
11.4 Medical Device Evaluation Committee
11.5 Medical device classification system
11.6 Registration process of medical device
11.7 Conclusion
References
Chapter 12. Regulations of medical devices in Russia
Abstract
12.1 Introduction
12.2 Medical device definition
12.3 Classification of medical devices
12.4 Documents required
12.5 Russia medical device registration requirements
12.6 Labeling requirements
12.7 Documents required for foreign manufacturer
12.8 Approval of medical devices in Russia
12.9 Regulations of medical devices in Russia
12.10 Renewal of certain national standards related to medical devices in Russia
12.11 State registration of medical devices
12.12 Conclusion
References
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Medical Device Regulations

A Complete Guide

Purchase options

BLOOM INTO SPRING SAVINGS

Institutional subscription on ScienceDirect

Aakash Deep

Related books