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E-grāmata: Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

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  • Formāts: 654 pages
  • Izdošanas datums: 28-Mar-2018
  • Izdevniecība: Pan Stanford Publishing Pte Ltd
  • Valoda: eng
  • ISBN-13: 9780429996764
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Handbook of Medical Device Regulatory Affairs in Asia: Second EditionPalielināt
  • Formāts: 654 pages
  • Izdošanas datums: 28-Mar-2018
  • Izdevniecība: Pan Stanford Publishing Pte Ltd
  • Valoda: eng
  • ISBN-13: 9780429996764
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors.

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Preface xxxiii
Chapter 1 How to Train University Students in Regulatory Affairs
1(6)
Raymond K.Y. Tong
1.1 Introduction
1(1)
1.2 A Sample of Regulatory Affairs Exercises for Students
2(5)
1.2.1 Background
2(2)
1.2.2 Lifelong Learning
4(3)
Part 1: Introduction
Chapter 2 The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals
7(10)
David Martin
Neil Lesser
2.1 Introduction
7(1)
2.2 Drivers of Change
8(2)
2.3 Historical Role and Skill Set of a Regulatory Professional
10(2)
2.4 Changing Role and Skill Set of the Regulatory Professional
12(1)
2.5 Develop as a Center of Intelligence
12(1)
2.6 Advance toward Strategic Relationship Management
13(1)
2.7 Develop as a Strategic Business Partner
13(1)
2.8 Conclusion: What Will It Take to Get There?
14(3)
Chapter 3 The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments
17(8)
Fredrik Dalborg
3.1 Introduction
17(1)
3.2 Key Trends in the Asia Medical Device Industry
18(1)
3.3 The Role of the Asia RA Team in a Global Medical Device Organization
19(1)
3.4 Coordination between Commercial Teams and RA Teams
20(1)
3.5 The Role of the RA Team during the Different Stages of a Product Life
21(2)
3.5.1 Product Development
21(1)
3.5.2 Market Introduction
21(1)
3.5.3 Product Maintenance
22(1)
3.5.4 Product Phase-Out
22(1)
3.6 The RA Professional: A Trusted Advisor
23(1)
3.7 Summary
24(1)
Chapter 4 Commercial Sense and What It Means for a Regulatory Manager or Executive
25(10)
Annie Joseph
4.1 Know the Basics
26(1)
4.1.1 Marketing or Commercial Plan
26(1)
4.1.2 Priority Products and How They Are Ranked in the Company
27(1)
4.1.3 Know Your Commercial People
27(1)
4.2 Maintain a Healthy Communication
27(1)
4.3 Be Proactive and Part of the Solution
27(2)
4.4 Remain the Expert and Provide Clarity to the Organization
29(1)
4.5 Be a Champion for New Product Launches
29(6)
Chapter 5 Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally
35(8)
May Ng
Martin Ng
Ray Soh
Fadzlon Yunos
Stephen Hsu
5.1 Introduction
35(1)
5.2 Information in Regulatory Strategy
36(4)
5.2.1 Device Name
36(1)
5.2.2 Device Description
37(1)
5.2.3 Intended Use
37(1)
5.2.4 Country of Interest
38(1)
5.2.5 Device Classification
38(1)
5.2.6 Product Registration or Conformity Assessment Route and Its Approval Timeline
39(1)
5.2.7 Technical Documentation Requirement
39(1)
5.2.8 Quality Management System Requirement
39(1)
5.2.9 Clinical Assessment
40(1)
5.2.10 Reimbursement Assessment
40(1)
5.3 Conclusion
40(3)
Chapter 6 Regulatory Affairs as a Business Partner
43(4)
Claudette Joyce C. Perilla
Chapter 7 Introduction to Regulatory Affairs Professionals' Roles
47(4)
Dacia Su
Chapter 8 What It Means to Be a Medtech Regulatory Journalist
51(6)
Amanda Maxwell
Chapter 9 Affordable Access to Medical Devices in Developing Countries
57(12)
Rosanna W. Peeling
Tikki Pang
9.1 Introduction
57(1)
9.2 Why Is Affordable Access to Medical Devices Important for Developing Countries?
58(3)
9.2.1 Emergency Preparedness
59(1)
9.2.2 Efficiency and Effectiveness of Health Systems
59(1)
9.2.3 Health Equity
60(1)
9.3 Case Studies
61(4)
9.3.1 Delay in Eligibility to Treatment for HIV
61(1)
9.3.2 Delay in Access to Early Diagnosis of Tuberculosis
62(1)
9.3.3 Misleading Claims of Test Performance for Dengue Rapid Tests
62(1)
9.3.4 Case Study-Access versus Performance: Basis for FDA Approval of the First Over-the-Counter Rapid HIV Test in the United States
63(1)
9.3.4.1 Background
63(1)
9.3.4.2 Performance expectations
63(1)
9.3.4.3 Risk benefit analysis
64(1)
9.4 The Way Forward
65(4)
Chapter 10 Regulatory Specialists in Medical Devices in Europe: Meeting the Challenge of Keeping Current in a Changing Environment-How TOPRA Supports Professionals in a Dynamic Industry
69(10)
Lynda J. Wight
10.1 The European MedTech Environment
69(2)
10.2 What Is TOPRA?
71(1)
10.3 Why Be a TOPRA Member?
71(1)
10.4 What Support Is Offered?
72(3)
10.4.1 Competency Frameworks
72(1)
10.4.2 Training and Development
73(1)
10.4.3 Education
74(1)
10.4.4 Networks and Collaborations
75(1)
10.4.5 Information
75(1)
10.5 Looking to the Future
75(4)
Part 2: Medical Device Safety And Related ISO Standards
Chapter 11 Biomedical Devices: Overview
79(14)
Piu Wong
11.1 Historic Aspect of Medical Devices
79(2)
11.2 Biomedical Market Environment
81(1)
11.3 Orthopedics
82(4)
11.3.1 Market
82(1)
11.3.2 Materials
83(1)
11.3.3 Biocompatibility
83(1)
11.3.4 Fabrication
84(1)
11.3.5 Polyethylene Fabrication
84(2)
11.4 Vision Care
86(2)
11.4.1 Market
86(1)
11.4.2 Diagnostic Devices
86(1)
11.4.3 Treatment
87(1)
11.5 Diabetics
88(1)
11.6 Obesity
88(1)
11.7 Vascular Disease
88(1)
11.8 Concluding Remarks
89(4)
Chapter 12 Labeling, Label, and Language: A Truly Global Matter
93(14)
Evangeline D. Loh
Jaap L. Laufer
12.1 Introduction
93(2)
12.2 Definition of Labeling
95(2)
12.3 Elements of Labeling
97(2)
12.4 Risk Management, Clinical Evaluation and Labeling: The Core Triangle for Safe and Effective Use of the Device
99(2)
12.5 Labeling and Promotion
101(1)
12.6 e-Labeling, Web Sites, Internet, and Social Media: A Brave New World for Labeling
101(2)
12.7 Language, Language Level, and Intended User
103(2)
12.8 Conclusion
105(2)
Chapter 13 Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific
107(22)
Seow Li-Ping Geraldine
13.1 Introduction
107(1)
13.2 Medical Device Clinical Trials versus Pharmaceutical Clinical Trials
108(3)
13.3 Regulation of Clinical Trials
111(6)
13.4 Country Regulations
117(8)
13.4.1 Australia
117(2)
13.4.2 China
119(1)
13.4.3 Hong Kong
120(1)
13.4.4 India
120(1)
13.4.5 Malaysia
121(1)
13.4.6 New Zealand
121(1)
13.4.7 Singapore
122(1)
13.4.8 South Korea
123(1)
13.4.9 Taiwan
124(1)
13.4.10 Thailand
125(1)
13.5 Moving Ahead as Regulatory Affairs Professionals
125(4)
Chapter 14 Medical Device Classification Guide
129(24)
Patricia Teysseyre
14.1 How to Carry Out Medical Device Classification
129(2)
14.1.1 Scope
129(1)
14.1.2 Definitions
130(1)
14.2 Main Classifications
131(6)
14.2.1 Medical Devices
131(1)
14.2.2 Active Devices
131(1)
14.2.3 IVD Devices
132(2)
14.2.4 IVD Case Study
134(1)
14.2.4.1 US FDA
135(1)
14.2.4.2 Canada
135(1)
14.2.4.3 EU
136(1)
14.2.4.4 Singapore
137(1)
14.3 Medical Device Classification: Practical Examples
137(16)
Chapter 15 ISO 13485:2003/2016-Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes
153(22)
Gert Bos
15.1 Introduction
153(1)
15.2 Background and Origins of ISO 13485:2003
154(2)
15.3 Quality Management Systems
156(2)
15.4 ISO 9000 and ISO 13485 Quality Management System Family of Standards
158(1)
15.5 Global Regulatory Footprint of ISO 13485:2003
158(1)
15.6 Implementing an ISO 13485:2003 Quality Management System
159(1)
15.7 Process Approach
160(1)
15.8 Planning the Implementation
161(1)
15.9 Scope, Exclusions, and Non-Applicability
162(1)
15.10 Document Control
162(1)
15.11 Record Completion and Control
163(1)
15.12 Management Responsibility
164(1)
15.13 Resource Management
164(1)
15.14 Product Realization
165(1)
15.15 Risk Management
165(1)
15.16 Design and Development
165(3)
15.17 Purchasing and Supplier Control
168(1)
15.18 Production and Service Provision
169(1)
15.19 Monitoring and Measuring, Including Internal Audits and Management Review
170(1)
15.20 Control of Non-Conforming Product
170(1)
15.21 Analysis of Data
171(1)
15.22 Improvement: Corrective Action and Preventive Action
171(1)
15.23 Purpose and Goal of ISO 13485:2003 Certification
172(1)
15.24 Achieving Certification and Continuing to Maintain Certification
172(3)
Chapter 16 ISO 14971: Application of Risk Management to Medical Devices
175(18)
Tony Chan
Raymond K.Y. Tong
16.1 Introduction
175(4)
16.2 The Foundation of a Risk Management Framework: Policy, Plan, Team, Process, and Documentation
179(1)
16.2.1 Policy
179(1)
16.2.2 Plan
179(1)
16.2.3 Team
179(1)
16.2.4 Process
180(1)
16.2.5 Documentation
180(1)
16.3 The RM Process
180(4)
16.3.1 Analyze Risk
180(1)
16.3.2 Evaluate Risk
181(1)
16.3.3 Control Risk
181(2)
16.3.4 Feedback from Production and Post-Production Information
183(1)
16.4 Conclusion
184(1)
16.5 Case Study-An Example to Illustrate Risk Management on a Medical Device: Functional Electrical Stimulation System for Walking
184(9)
16.5.1 Risk Management Process
186(7)
Chapter 17 Medical Devices: IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
193(8)
Gabriela Ehrlich
17.1 Introduction
193(2)
17.2 What Is an IEC International Standard?
195(1)
17.3 How Are IEC International Standards Developed?
195(1)
17.4 IEC International Standards for Medical Devices
196(2)
17.5 Conformity Assessment for Medical Devices
198(2)
17.6 Conclusion
200(1)
Chapter 18 Introduction of Good Submission Practice
201(16)
Isao Sasaki
18.1 Introduction
201(1)
18.2 Concept of Good Registration Management
202(1)
18.3 Principles of Good Submission
203(1)
18.4 Management of Submission
204(4)
18.4.1 Planning for Submission
204(1)
18.4.2 Preparation and Submission of Application Dossier
205(2)
18.4.3 Quality Check
207(1)
18.5 Communications
208(4)
18.5.1 Communications with the Review Authorities
209(2)
18.5.2 Communication within Applicants' Organization
211(1)
18.6 Competencies and Training
212(2)
18.6.1 Core Competency of Applicants
212(1)
18.6.2 Training and Capacity Building
213(1)
18.7 Conclusion
214(3)
Part 3: Medical Device Regulatory System In The United States, European Union, Saudi Arabia, And Latin America
Chapter 19 United States Medical Device Regulatory Framework
217(22)
James Bertram
19.1 Introduction
217(1)
19.2 The FDA Center for Devices and Radiological Health
218(1)
19.3 Legislation and Device Laws
219(1)
19.3.1 FDA Law vs. FDA Regulations vs. FDA Guidance
219(1)
19.4 The Regulatory Environment for Bringing a Medical Device to Market
220(1)
19.5 Regulatory Considerations for Medical Devices
221(10)
19.5.1 Definition of Medical Devices
221(1)
19.5.2 Classification of Medical Devices
222(1)
19.5.2.1 General controls
225(1)
19.5.2.2 Special controls
225(1)
19.5.2.3 Premarket approval
226(1)
19.5.3 Convenience Kits
226(1)
19.5.4 Labeling
226(1)
19.5.5 Adulteration and Misbranding
227(1)
19.5.6 Establishment Registration and Medical Device Listing
227(1)
19.5.7 Quality System Regulation/Good Manufacturing Practices
228(1)
19.5.8 Medical Device Reporting
229(1)
19.5.9 Unique Device Identification
229(1)
19.5.10 User Fees
230(1)
19.6 Premarket Submissions for Medical Devices
231(6)
19.6.1 eCopy Program for Medical Device Submissions
231(1)
19.6.2 Premarket Notification
231(1)
19.6.2.1 Predicate device and substantial equivalence
232(1)
19.6.3 De Novo Request
233(1)
19.6.4 Premarket Approval Application
234(1)
19.6.5 Investigational Device Exemption
235(1)
19.6.6 Presubmission: Requesting Feedback
236(1)
19.6.7 Promoting Innovation: Expedited Access Program
236(1)
19.7 Summary
237(2)
Chapter 20 Regulation of Combination Products in the United States
239(10)
John Barlow Weiner
Thinh X. Nguyen
20.1 What Products Are Considered Combination Products
240(1)
20.2 The Standards for Determining If a Product Is a Combination Product
240(2)
20.3 The Standards for Determining Which FDA Component Has Primary Responsibility for Regulating a Combination Product
242(1)
20.4 Requests for Designation
243(1)
20.5 Premarket Review Considerations
244(1)
20.6 Post-Market Regulatory Considerations
245(1)
20.7 Role of Office of Combination Products
246(1)
20.8 International Harmonization and Coordination Activities with Foreign Counterparts
246(1)
20.9 FDA Resources for Obtaining Additional Information
247(2)
Chapter 21 European Union: Medical Device Regulatory System
249(50)
Arkan Zwick
21.1 Glossary of Terms
249(2)
21.2 European Union: Medical Device Market and Structure
251(2)
21.3 New Approach: Global Approach Concepts
253(1)
21.4 Harmonized Standards and Presumption of Conformity
254(2)
21.5 European Associations
256(3)
21.6 Overview of Medical Devices Directives
259(1)
21.7 Guidelines
260(1)
21.8 Definitions
261(6)
21.8.1 Medical Device
261(1)
21.8.2 CE Mark
262(1)
21.8.3 Competent Authority
263(1)
21.8.4 Notified Body: Conformity Assessment Body
264(1)
21.8.5 Legal Manufacturer
265(1)
21.8.6 Authorized Representative
266(1)
21.9 Classification
267(3)
21.9.1 Medical Devices
267(1)
21.9.2 Active Implantable Medical Devices
268(1)
21.9.3 In vitro and Diagnostics Medical Devices
269(1)
21.10 Conformity Assessment Procedures
270(4)
21.11 Essential Requirements
274(3)
21.12 Labeling
277(1)
21.13 Technical Documentation
278(1)
21.14 Quality Management System
279(6)
21.15 Risk Management
285(1)
21.16 Clinical Evaluation
285(2)
21.17 CE Mark Certificate and Declaration of Conformity
287(1)
21.18 Post-Market Surveillance
288(1)
21.19 Evolution of MDD 93/42/EEC and Impacts
289(3)
21.20 The New EU Regulation 2017/745 on Medical Devices
292(1)
21.21 Timetable
293(1)
21.22 General Safety and Performance Requirements
293(1)
21.23 Stronger Notified Body Oversight
294(1)
21.24 Economic Operators
294(1)
21.25 Clinical Evidence, Post-Market Follow-Up, and Risk Reviews
294(1)
21.26 PSUR/PMCF Reports
295(1)
21.27 Eudamed
295(1)
21.28 Overview of All Interactions and Key Terminology
296(3)
Chapter 22 Regulation of Combination Products in the European Union
299(12)
Janine Jamieson
Elizabeth Baker
22.1 Introduction: Legal Basis
299(4)
22.1.1 Definitions
300(1)
22.1.1.1 Medical device
300(1)
22.1.1.2 Medicinal product
301(1)
22.1.1.3 Combination products: Principal mode of action
302(1)
22.1.1.4 Borderline products: MEDDEV 2.1/3
303(1)
22.1.1.5 Borderline products: Manual of decisions
303(1)
22.2 Combination Products Regulated as Medicinal Products
303(1)
22.2.1 Examples of Combination Products Regulated as Medicinal Products
304(1)
22.3 Combination Products Regulated as Medical Devices
304(1)
22.3.1 Examples of Combination Products Regulated as Drug-Delivery Devices
304(1)
22.4 Combination Products Regulated as Devices Incorporating, as an Integral Part, an Ancillary Medicinal Substance
305(1)
22.4.1 Examples of Devices Incorporating an Ancillary Medicinal Substance
305(1)
22.4.2 Examples of Drug Substances Incorporated into Devices
306(1)
22.4.3 Assessment of the Medicinal Substance Aspects of a Device Incorporating an Ancillary Medicinal Substance
306(1)
22.5 The Consultation Process
306(1)
22.6 Information to Be Provided on the Ancillary Medicinal Substance
307(2)
22.6.1 General
307(1)
22.6.2 Quality, Safety, Usefulness
307(1)
22.6.2.1 Quality
307(1)
22.6.2.2 Safety and usefulness
308(1)
22.6.2.3 Guidance
308(1)
22.7 Other Combination Products
309(2)
Chapter 23 Medical Device Regulatory Affairs in Latin America
311(28)
Carolina Cera
Gladys Servia
23.1 Introduction
311(1)
23.2 Latin America Market Analysis
312(2)
23.2.1 Medical Device Market in Latin America
312(1)
23.2.2 Trade Blocs
313(1)
23.3 Overview of Medical Device Regulation in Latin America
314(4)
23.3.1 Evolution of the Medical Device Regulation in Latin America
314(1)
23.3.2 Regulatory Environment in Latin America
315(1)
23.3.2.1 Finding local registration holder
315(1)
23.3.2.2 Harmonization of medical device
316(1)
23.3.2.3 Challenges in the region
317(1)
23.4 Argentina and Brazil Medical Device System
318(10)
23.4.1 Definition of Medical Device
319(1)
23.4.2 Classification of Medical Devices
319(1)
23.4.3 Argentina Medical Device System
319(1)
23.4.3.1 Regulatory authority and medical device regulation
319(1)
23.4.3.2 Registration process of medical devices
320(1)
23.4.3.3 Documents and labeling requirements
320(1)
23.4.3.4 Official registration fee
321(1)
23.4.3.5 Timeline
322(1)
23.4.3.6 Regulatory action for changes and device modifications
322(1)
23.4.3.7 Post-market surveillance
322(1)
23.4.4 Brazil Medical Device System
323(1)
23.4.4.1 Registration process of medical devices in Brazil
323(1)
23.4.4.2 Documents and labeling requirements
325(1)
23.4.4.3 Official registration fee
326(1)
23.4.4.4 Timeline
326(1)
23.4.4.5 Regulatory action for changes and device modification
327(1)
23.4.4.6 Post-market surveillance
328(1)
23.5 Colombia Medical Device System
328(5)
23.5.1 Regulatory Authority and Medical Device Regulation
328(1)
23.5.2 Definition of Medical Device
329(1)
23.5.3 Classification of Medical Devices
329(1)
23.5.4 Registration of Medical Devices
330(1)
23.5.4.1 Regulatory process
330(1)
23.5.4.2 Documents required
330(1)
23.5.4.3 Official registration fee
332(1)
23.5.4.4 Timeline
332(1)
23.5.4.5 Regulatory action for changes and device modifications
332(1)
23.5.4.6 Post-market surveillance
333(1)
23.6 Mexico Medical Device System
333(6)
23.6.1 Regulatory Authority and Medical Device Regulation
333(1)
23.6.2 Definition of Medical Device
334(1)
23.6.3 Classification of Medical Devices
334(1)
23.6.4 Registration of Medical Devices
335(1)
23.6.4.1 Registration process
335(1)
23.6.4.2 Documents and labeling requirements
335(1)
23.6.4.3 Official registration fee
335(1)
23.6.4.4 Timeline
337(1)
23.6.4.5 Regulatory action for changes and device modifications
337(1)
23.6.5 Post-Market Surveillance
337(2)
Chapter 24 Saudi Arabia: Medical Device Regulation System
339(22)
Ali Aldalaan
24.1 Introduction
339(1)
24.2 Legislative Responsibilities
340(1)
24.3 Executive Responsibilities
341(1)
24.4 Surveillance Responsibilities
342(1)
24.5 Regulation Overview
342(1)
24.6 Registration Requirements
343(1)
24.7 Information to Be Provided to the SFDA
344(2)
24.8 Medical Device Marketing Authorization
346(2)
24.9 Medical Device Listing
348(1)
24.10 Registration Fees
349(2)
24.11 General Information and Documentary Evidence Need to Be Provided to the SFDA
351(1)
24.12 Labeling Requirement for Medical Device
352(1)
24.13 Clinical Evaluation
353(1)
24.14 Post-Market Surveillance Requirement
354(7)
Part 4: Medical Device Regulatory System In Asia-Pacific Region
Chapter 25 Australian Medical Device Regulations: An Overview
361(16)
Petahn McKenna
25.1 Medical Device Market in Australia
361(1)
25.2 Medical Device Regulations
362(1)
25.2.1 Overview
362(1)
25.2.2 Regulating Authority
363(1)
25.2.3 Legislation and Guidance
363(1)
25.3 Definition of Medical Device
363(1)
25.4 Classification of Medical Devices
364(2)
25.4.1 Classification of IVD Medical Devices
365(1)
25.5 Inclusion of Medical Devices on the ARTG
366(6)
25.5.1 Process for Supplying a Medical Device in Australia
366(3)
25.5.2 Process for Including Class 1 IVD Medical Devices in the ARTG
369(1)
25.5.3 Process for Including IVD Medical Devices in the ARTG
370(2)
25.6 Same Kind of Medical Device
372(1)
25.7 Unique Product Identifier
372(1)
25.8 In vitro Diagnostic UPIs
373(1)
25.9 Renewal
374(1)
25.10 Documentation Requirements
374(1)
25.10.1 Conformity Assessment Applications
374(1)
25.11 Application Audits
375(1)
25.12 Access to Unapproved Medical Devices
376(1)
Chapter 26 China: Medical Device Regulatory System
377(24)
Jean Zhang
26.1 Introduction
377(1)
26.2 Market Overview
378(1)
26.3 Overview of Regulatory Environment and What Laws/Regulations Govern the Medical Devices
378(3)
26.3.1 Guidance
380(1)
26.3.2 Standards
380(1)
26.4 Regulatory Body
381(1)
26.5 Regulatory Overview
381(17)
26.5.1 Definition of Medical Device
381(1)
26.5.2 Classification of Medical Devices
382(2)
26.5.3 Filing Process for Class I Medical Device
384(1)
26.5.4 Registration Process for Class II or III Medical Device
385(1)
26.5.4.1 Medical device registration certificate
385(1)
26.5.4.2 Documents needed for registration application
388(1)
26.5.4.3 Product technical requirements and registration testing
389(1)
26.5.4.4 Biocompatibility evaluation
389(1)
26.5.4.5 Clinical evaluation and clinical trials
390(1)
26.5.4.6 Enforcing GMPs
394(1)
26.5.4.7 Timeframes
394(1)
26.5.4.8 Registration alteration
396(1)
26.5.4.9 Registration renewal
396(1)
26.5.4.10 The registration fee
396(1)
26.5.4.11 Innovative medical devices
397(1)
26.5.4.12 Drug/device combination products
398(1)
26.6 Monitoring Adverse Events
398(1)
26.7 Managing Recalls
399(2)
Chapter 27 Hong Kong: Medical Device Regulatory System
401(12)
Jack Wong
Linda Chan
27.1 Market Overview
401(4)
27.1.1 Market Environment
401(1)
27.1.2 Overview of Regulatory Environment and What Laws/Regulations Govern Medical Devices
402(1)
27.1.3 Regulatory Body
403(2)
27.2 Regulatory Overview
405(6)
27.2.1 The Definition of Medical Device
405(1)
27.2.2 Classification of Medical Devices
406(1)
27.2.3 The Role of Distributors or Local Subsidiaries
407(1)
27.2.4 Product Registration or Conformity Assessment Route and Time Required
407(1)
27.2.4.1 Suggested registration routes/steps
409(1)
27.2.4.2 Technical material requirement
409(1)
27.2.4.3 The labeling requirement of medical device
410(1)
27.2.4.4 Post-marketing surveillance requirement
410(1)
27.2.4.5 Manufacturing-related regulation
411(1)
27.2.4.6 Clinical trial related regulation
411(1)
27.2.4.7 Is there a procedure for mutual recognition of foreign marketing approval or international standards?
411(1)
27.3 Commercial Aspects
411(1)
27.4 Upcoming Events
412(1)
Chapter 28 India: Medical Device Regulatory System
413(24)
Kulwant S. Saini
28.1 Market Overview
413(11)
28.1.1 Market Environment
413(1)
28.1.2 Overview of Regulatory Environment and What Laws/Regulations Govern Medical Devices
414(4)
28.1.3 Functions Undertaken by DCGI and Central Government
418(1)
28.1.3.1 Statutory functions
418(1)
28.1.3.2 Other functions
418(1)
28.1.4 Functions Undertaken by the FDA and State Governments
419(1)
28.1.4.1 Statutory functions
419(1)
28.1.5 Guidance Documents
420(1)
28.1.6 Indian Pharmacopoeia) Commission
421(1)
28.1.7 Detail of Key Regulator(s)
421(3)
28.2 Regulatory Overview
424(9)
28.2.1 Definition of Medical Device
424(1)
28.2.2 Classification of Medical Devices
425(1)
28.2.3 Role of Distributors or Local Subsidiaries
425(1)
28.2.4 Product Registration or Conformity Assessment Route and Time Required
426(2)
28.2.5 Quality System Regulation
428(1)
28.2.6 Product Registration and Quality System Regulation for Combined Device-Drug Product
428(1)
28.2.7 Registration Fee
429(1)
28.2.8 Technical Material Requirement
430(1)
28.2.9 The Labelling Requirement of Medical Device
430(1)
28.2.10 Post-Marketing Surveillance Requirement
431(1)
28.2.11 Manufacturing-Related Regulation
431(1)
28.2.12 Clinical Trial-Related Regulation
432(1)
28.2.13 Is There a Procedure for Mutual Recognition of Foreign Marketing Approval or International Standards?
433(1)
28.3 Commercial Aspects
433(1)
28.3.1 Any Price Control of Medical Device
433(1)
28.3.2 Are Parallel Imports Allowed?
434(1)
28.3.3 Any Advertisement Regulation of Medical Device?
434(1)
28.4 Upcoming Regulation Changes
434(2)
28.5 Related Agencies/Departments and Ministries
436(1)
Chapter 29 Indonesia: Medical Device Regulatory System
437(22)
Mita Rosalina
29.1 Introduction
437(2)
29.2 Regulating Authority
439(1)
29.3 Definition of Medical Device
439(1)
29.4 Classification of Medical Devices
440(1)
29.5 Registration of Medical Devices
441(3)
29.5.1 Process
441(1)
29.5.2 Documents Required
442(1)
29.5.3 Official Registration Fee
442(1)
29.5.4 Time Line
442(1)
29.5.5 Validity of Product License
443(1)
29.5.6 Indonesian Labeling Requirement
443(1)
29.5.7 Regulatory Action for Changes and Device Modifications
443(1)
29.6 Post-Market Surveillance System
444(15)
Chapter 30 Japan: Medical Device Regulatory System
459(16)
Atsushi Tamura
30.1 Introduction
459(1)
30.2 Regulatory Agency in Japan
460(3)
30.2.1 The Ministry of Health, Labour and Welfare
460(1)
30.2.2 Pharmaceuticals and Medical Devices Agency
460(1)
30.2.3 Shared Responsibility of MHLW and PMDA on Medical Device Regulation
460(3)
30.3 Legislation of Medical Devices
463(5)
30.3.1 Classification of Medical Devices
464(1)
30.3.2 Type of Product's Registration
465(1)
30.3.2.1 Notification
465(1)
30.3.2.2 Pre-market certification
465(1)
30.3.2.3 Pre-market approval
466(1)
30.3.3 Marketing Authorization Holder
466(1)
30.3.4 Manufacturer License (Art. 13)/Accreditation of Foreign Manufacturer (Art. 13-3)
467(1)
30.4 Related Requirements
468(1)
30.4.1 Quality Management System
468(1)
30.4.1.1 QMS conformity as an essential requirement
468(1)
30.4.1.2 QMS inspections
469(1)
30.4.2 Good Quality Practices
469(1)
30.5 MAH's Obligations During Post-Market Phase
469(3)
30.5.1 Collection, Analysis and Reporting of Safety Information
471(1)
30.5.2 Recall
471(1)
30.5.3 Post-Marketing Safety Management
472(1)
30.6 PMDA's Obligations During Post-Market Phase
472(3)
30.6.1 New Challenge
473(1)
30.6.2 Information Services
473(2)
31 Korea: Medical Device Regulatory System
475(38)
Young Kim
Soo Kyeong Shin
Jamie Noh
31.1 General Market Overview
475(16)
31.1.1 Key Healthcare Market Indicators of Korea
475(3)
31.1.2 Medical Device Market
478(2)
31.1.3 Import
480(4)
31.1.4 Domestic Production
484(7)
31.1.5 Export
491(1)
31.2 Regulatory Approvals
491(12)
31.2.1 Responsible Authorities
491(2)
31.2.2 Qualifications for Medical Device Business
493(1)
31.2.2.1 Medical device business license
493(1)
31.2.2.2 Certification to medical device quality system management
494(1)
31.2.2.3 Medical device product approval or certification or notification
494(7)
31.2.3 Strategic Plan and Useful Tips for Efficient Registration
501(1)
31.2.3.1 Face-to-face meeting with reviewer
501(1)
31.2.3.2 Respond to reviewer's questions with respect
502(1)
31.2.3.3 Retain experienced regulatory affairs professionals
502(1)
31.3 Reimbursement
503(10)
31.3.1 Overview of Reimbursement Scheme
503(2)
31.3.2 Medical Supplies
505(1)
31.3.2.1 Submission
505(1)
31.3.2.2 Pricing options
506(1)
31.3.2.3 Timeframes
507(1)
31.3.2.4 Stakeholders
508(2)
31.3.3 Health Technology Assessment
510(3)
Chapter 32 Malaysia: Medical Device Regulatory System
513(10)
Yew Siak Wah
32.1 Medical Device Registration
513(1)
32.2 Regulating Authority
514(1)
32.3 Definition of Medical Device
514(1)
32.4 Registration of Medical Devices
515(1)
32.4.1 Medical Device and In Vitro Diagnostic Medical Device
515(1501)
32.4.2 Medical Device Order
2016 515
32.5 Post-Market Surveillance and Vigilance
516(1)
32.6 Medical Device Labelling
517(1)
32.7 Regulatory Action for Changes and Device Modifications
517(6)
32.7.1 Change Notification
517(1)
32.7.2 Change of Ownership for Medical Device Registration
518(2)
32.7.3 Refurbishment of Medical Device
520(3)
Chapter 33 Philippines: Medical Device Regulatory System and Licensing
523(18)
Mitzumi R. Duclayan
Mary Claire Cacanindin
Jennifer Cheah
33.1 Market Overview
523(2)
33.2 Introduction to the Philippines Regulatory System
525(2)
33.3 Regulatory Overview
527(6)
33.4 History of Medical Device Regulation
533(2)
33.5 Regional Medical Device Harmonization under Development through ASEAN
535(1)
33.6 Definition of Medical Device in the Philippines
536(1)
33.7 Registration with the Food and Drug Administration
537(1)
33.8 Import Labeling
538(1)
33.9 Import Documentation
538(1)
33.10 Summary of Regulatory System
539(1)
33.11 Contacts
539(2)
Chapter 34 Singapore: Medical Device Regulatory System
541(28)
Annie Goh
34.1 Market
541(1)
34.2 Singapore Medical Device Regulation
542(4)
34.2.1 Singapore Standard SS 620: 2016
543(1)
34.2.2 Telehealth
543(1)
34.2.3 New Schemes
544(1)
34.2.4 Class A Medical Device
544(1)
34.2.5 Class B Medical Device
545(1)
34.2.6 Health Sciences Authority
545(1)
34.3 Definition of Medical Device
546(1)
34.4 Classification of Medical Devices
547(2)
34.5 Grouping of Medical Device
549(3)
34.5.1 Single
549(1)
34.5.2 Family
549(1)
34.5.3 Group
550(1)
34.5.4 System
550(1)
34.5.5 IVD Test Kit
551(1)
34.5.6 IVD Cluster
551(1)
34.5.7 Dental Grouping Terms
552(1)
34.6 Product Registration
552(5)
34.6.1 Reference Regulatory Agencies
552(1)
34.6.2 Full Evaluation
553(1)
34.6.3 Abridged Evaluation
553(1)
34.6.4 Expedited Evaluation
554(1)
34.6.5 Immediate Evaluation
555(1)
34.6.6 Class A Medical Device
555(2)
34.7 Medical Devices Incorporating Medicinal Product
557(1)
34.7.1 ASEAN Common Submission Dossier Template
557(1)
34.8 Processing of Application
558(1)
34.8.1 Full, Abridged, Expedited Evaluation
558(1)
34.8.2 Immediate Evaluation
558(1)
34.8.3 Class A Medical Device
559(1)
34.9 Turn-Around Time for Product Registration
559(1)
34.10 Product Registration Fee
560(1)
34.11 Medical Device Labeling
560(1)
34.12 Post-Market Surveillance
560(2)
34.12.1 Adverse Event
561(1)
34.12.2 Field Safety Corrective Action
562(1)
34.13 Manufacturer, Importer, and Wholesaler of Medical Devices
562(1)
34.13.1 Type of Licenses
563(1)
34.13.2 Quality Management System
563(1)
34.14 Clinical Trial
563(1)
34.15 Special Authorization Route
564(2)
34.16 Price Control on Medical Device
566(1)
34.17 Medical Device Advertisement
566(3)
Chapter 35 Taiwan: Medical Device Regulatory System
569(12)
Pei-Weng Tu
35.1 Market Overview
569(3)
35.1.1 Overview of Structure and Funding of Local Healthcare System
569(2)
35.1.2 Overview of Regulatory Environment and Laws/Regulations Governing Medical Devices
571(1)
35.1.3 Detail of Key Regulator(s)
572(1)
35.2 Regulatory Overview
572(4)
35.2.1 Definition of Medical Device
572(2)
35.2.2 Classification of Medical Devices
574(1)
35.2.3 Role of Distributors or Local Subsidiaries
574(1)
35.2.4 Product Registration, Technical Material Requirement, and Time Required
575(1)
35.3 Quality System Regulation
576(1)
35.4 Combined Device-Drug Product
576(1)
35.5 Registration Fee
576(1)
35.6 Labeling Requirements of Medical Devices
576(1)
35.7 Post-Marketing Surveillance Requirement
577(1)
35.8 Manufacturing-Related Regulation
577(1)
35.9 Clinical Trial-Related Regulation
577(1)
35.10 International Cooperation
578(1)
35.11 Commercial Aspects
579(1)
35.11.1 Price Control of Medical Device
579(1)
35.11.2 Parallel Imports
579(1)
35.11.3 Advertisement Regulation of Medical Devices
579(1)
35.12 Upcoming Events
579(2)
Chapter 36 Thailand: Regulatory and Medical Device Control
581(10)
Yuwadee Patanawong
Nachsupol Arunaramamporn
36.1 Market Overview
581(1)
36.2 Medical Device in Regional Market
582(1)
36.3 Medical Device Regulations
583(1)
36.4 Definition of Medical Device
583(1)
36.5 Medical Device Classification
584(1)
36.6 Documents Required for Medical Device Registration
585(2)
36.6.1 Level I Medical Devices
585(2)
36.6.2 For Level II Medical Devices
587(1)
36.6.3 For Level III Medical Devices
587(1)
36.7 Labeling
587(1)
36.8 Validity
588(1)
36.9 Summary
588(1)
36.10 Regulation and Guidance
589(1)
36.11 Future Developments
589(2)
Chapter 37 Vietnam: Medical Device Regulatory System
591(12)
Nguygen Minh Tuan
Le Thu Nga
37.1 Market Overview
591(1)
37.2 Overview of Regulatory Environment and Laws/Regulations Governing Medical Devices
592(1)
37.3 Regulatory Overview
593(1)
37.4 Classification of Medical Devices
594(3)
37.5 Product Registration or Conformity Assessment Route and Time Required
597(3)
37.6 Commercial Aspects
600(1)
37.7 Upcoming Events
600(3)
Chapter 38 A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company
603(6)
Jacky Devergne
38.1 Competitive Advantage
604(3)
38.1.1 Time to Market
604(1)
38.1.2 Barriers of Entry
605(1)
38.1.3 Continuity of Business
605(1)
38.1.4 Best Use of Resources
606(1)
38.2 The Right Organization
607(1)
38.2.1 Investing in an Effective RA Organization
607(1)
38.2.2 Integrating RA in Business Planning
607(1)
38.3 Conclusion
608(1)
Index 609
Jack Wong is regulatory affairs head, Asia Pacific, at Baxter Healthcare. He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products.

Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair of the Asia Regulatory Professional Association (ARPA)-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association.
Biežāk uzdotie jautājumi par e-grāmatām Biežāk uzdotie jautājumi par e-grāmatām
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