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

Edited by (Hong Kong Polytechnic University, Hung Hom, Kowloon), Edited by (Asia Regulatory Professional Association, Kwun Tong, Kowloon, Hong Kong)
  • Formāts: 616 pages
  • Izdošanas datums: 27-Mar-2013
  • Izdevniecība: Pan Stanford Publishing Pte Ltd
  • ISBN-13: 9789814411226
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Handbook of Medical Device Regulatory Affairs in AsiaPalielināt
  • Formāts: 616 pages
  • Izdošanas datums: 27-Mar-2013
  • Izdevniecība: Pan Stanford Publishing Pte Ltd
  • ISBN-13: 9789814411226
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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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Recenzijas

"This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility." Swee-Hin Teoh, PhD, BEng (1st Hon.), Professor in Bioengineering, Nanyang Technology University, Singapore

"While much has been written about US and European medical device regulations, the Asian regulatory picture has remained clouded for most people. This book is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region. It is a useful tool as companies and innovators are increasingly looking to Asia as not only a new market for existing products but a launching pad for new technologies." Mark Holmes, Terumo BCT, Inc., USA

"This is a very interesting book for biomedical engineering students and medical engineers and an important reference for regulatory affairs professionals. The chapters on quality management systems, such as ISO 13485 and ISO 14971, clinical trial guidelines, medical device classification guide, and the formation of the Asian Harmonization Working Party are well written in plain language." Dr. Kwok-kwan Chan, Hospital Authority, Hong Kong, Chairman in Biomedical Division (201213), Hong Kong Institution of Engineers

"[ It] provides extensive information about the medical device regulatory environment in Asia and the Middle East. In addition to overviews of 16 countries, it discusses medical device classification, ISO 13485 and ISO 14971 quality standards, affordable access, medical device harmonization initiatives in Asia, and other topics of both regional and global interest. The second half of the book reviews the regulatory systems for the following countries: Australia, China, Hong Kong, India, Indonesia, Japan, Jordan, Republic of Korea, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, UAE and Vietnam." Norman M. Goldfarb, Managing Director, First Clinical Research in Journal of Clinical Research Best Practices "This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility." Swee-Hin Teoh, PhD, BEng (1st Hon.), Professor in Bioengineering, Nanyang Technology University, Singapore

"While much has been written about US and European medical device regulations, the Asian regulatory picture has remained clouded for most people. This book is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region. It is a useful tool as companies and innovators are increasingly looking to Asia as not only a new market for existing products but a launching pad for new technologies." Mark Holmes, Terumo BCT, Inc., USA

"This is a very interesting book for biomedical engineering students and medical engineers and an important reference for regulatory affairs professionals. The chapters on quality management systems, such as ISO 13485 and ISO 14971, clinical trial guidelines, medical device classification guide, and the formation of the Asian Harmonization Working Party are well written in plain language." Dr. Kwok-kwan Chan, Hospital Authority, Hong Kong, Chairman in Biomedical Division (201213), Hong Kong Institution of Engineers

"[ It] provides extensive information about the medical device regulatory environment in Asia and the Middle East. In addition to overviews of 16 countries, it discusses medical device classification, ISO 13485 and ISO 14971 quality standards, affordable access, medical device harmonization initiatives in Asia, and other topics of both regional and global interest. The second half of the book reviews the regulatory systems for the following countries: Australia, China, Hong Kong, India, Indonesia, Japan, Jordan, Republic of Korea, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, UAE and Vietnam." Norman M. Goldfarb, Managing Director, First Clinical Research in Journal of Clinical Research Best Practices

Preface xxxi
Asia Regulatory Professional Association xxxiii
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(5)
PART 1 INTRODUCTION
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)
3 Ensuring Smooth Product Launch: Regulatory Interfaces with Marketing and Supply Chain
17(4)
Alok Mishra
3.1 Introduction
17(1)
3.2 New Product Pipeline
18(1)
3.3 Planned Launch Dates
18(1)
3.4 New Product Forecasts
19(1)
3.5 New Product Approval Dates
19(2)
4 What Is the Right Thing to Do?
21(4)
Jack Wong
4.1 Right Job
21(1)
4.2 Two Key Challenges in Our Job
22(1)
4.2.1 Quality
22(1)
4.2.2 Speed
22(1)
4.3 Regulatory Affairs Job Is a Combination of Science, Legal Affairs, and Moral
22(1)
4.4 Persons versus Things
22(3)
5 Affordable Access to Medical Devices in Developing Countries
25(10)
Rosanna W. Peeling
Tikki Pang
5.1 Introduction
25(1)
5.2 Why Is Affordable Access to Medical Devices Important for Developing Countries?
26(3)
5.2.1 Emergency Preparedness
27(1)
5.2.2 Efficiency and Effectiveness of Health Systems
27(1)
5.2.3 Health Equity
28(1)
5.3 Case Studies
29(4)
5.3.1 Delay in Eligibility to Treatment for HIV
29(1)
5.3.2 Delay in Access to Early Diagnosis of Tuberculosis
29(1)
5.3.3 Misleading Claims of Test Performance for Dengue Rapid Tests
30(1)
5.3.4 Case Study --- Access versus Performance: Basis for FDA Approval of the First Over- the- Counter Rapid HIV Test in the United States
31(1)
5.3.4.1 Background
31(1)
5.3.4.2 Performance expectations
31(1)
5.3.4.3 Risk benefit analysis
32(1)
5.4 The Way Forward
33(2)
6 A Story of Attention to Detail
35(4)
Richard Liu
PART 2 Medical Device Safety AND Related ISO Standards
7 Biomedical Devices: Overview
39(14)
Piu Wong
7.1 Historic Aspect of Medical Devices
39(2)
7.2 Biomedical Market Environment
41(1)
7.3 Orthopedics
42(4)
7.3.1 Market
42(1)
7.3.2 Materials
43(1)
7.3.3 Biocompatibility
43(1)
7.3.4 Fabrication
44(1)
7.3.5 Polyethylene Fabrication
44(2)
7.4 Vision Care
46(2)
7.4.1 Market
46(1)
7.4.2 Diagnostic Devices
46(1)
7.4.3 Treatment
47(1)
7.5 Diabetics
48(1)
7.6 Obesity
48(1)
7.7 Vascular Disease
48(1)
7.8 Concluding Remarks
49(4)
8 Labeling, Label, and Language: A Truly Global Matter
53(14)
Evangeline D. Loh
Jaap L. Laufer
8.1 Introduction
53(2)
8.2 Definition of Labeling
55(1)
8.3 Elements of Labeling
56(3)
8.4 Risk Management, Clinical Evaluation and Labeling: The Core Triangle for Safe and Effective Use of the Device
59(1)
8.5 Labeling and Promotion
60(1)
8.6 e-Labelling, Web Sites, Internet, and Social Media: A Brave New World for Labeling
61(2)
8.7 Language, Language Level and Intended User
63(1)
8.8 Conclusion
64(3)
9 Clinical Trials: Legal and Ethical Considerations of Increasing Globalization
67(12)
Paula Celine Trepman
9.1 Introduction
67(1)
9.2 The Increasing Trend of Offshore Clinical Trials
68(1)
9.3 International Standards to Protect Patients
69(1)
9.4 Breaches of Clinical Trial Legality
70(1)
9.5 Issues of Informed Consent
71(1)
9.6 Cultural and Social Factors
71(1)
9.7 Vulnerable Patient Populations
72(1)
9.8 Economic Considerations
72(1)
9.9 Comparison of Trial Population to Target Population
73(2)
9.10 Conclusion
75(4)
10 Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific
79(22)
Seow Li-Ping Geraldine
10.1 Introduction
79(1)
10.2 Medical Device Clinical Trials versus Pharmaceutical Clinical Trials
80(3)
10.3 Regulation of Clinical Trials
83(4)
10.4 Country Regulations
87(9)
10.4.1 Australia
89(2)
10.4.2 China
91(1)
10.4.3 Hong Kong
91(1)
10.4.4 India
91(1)
10.4.5 Malaysia
92(1)
10.4.6 New Zealand
92(1)
10.4.7 Singapore
93(1)
10.4.8 South Korea
94(1)
10.4.9 Taiwan
95(1)
10.4.10 Thailand
96(1)
10.5 Moving Ahead as Regulatory Affairs Professionals
96(5)
11 Medical Device Classification Guide
101(24)
Patricia Teysseyre
11.1 How to Carry Out Medical Device Classification
101(2)
11.1.1 Scope
101(1)
11.1.2 Definitions
102(1)
11.2 Main Classifications
103(6)
11.2.1 Medical Devices
103(1)
11.2.2 Active Devices
103(1)
11.2.3 IVD Devices
104(2)
11.2.4 IVD Case Study
106(1)
11.2.4.1 US FDA
107(1)
11.2.4.2 Canada
107(1)
11.2.4.3 EU
108(1)
11.2.4.4 Singapore
109(1)
11.3 Medical Device Classification: Practical Examples
109(16)
12 ISO 13485:2003 Medical Devices --- Quality Management Systems --- Requirements or Regulatory Purposes
125(20)
Ann Goodall
Gert Bos
12.1 Introduction
125(1)
12.2 Background and Origins of ISO 13485:2003
126(2)
12.3 Management Systems Standard
128(1)
12.4 Quality Management Systems
129(1)
12.5 ISO 9000 and ISO 13485 Quality Management System Family of Standards
130(1)
12.6 ISO 13485:2003 and Regulatory Requirements Around the World
131(1)
12.7 Good Reasons to Implement an ISO 13485: 2003 Quality Management System
132(1)
12.8 Process Approach
132(1)
12.9 Planning the Implementation
133(1)
12.10 Scope, Exclusions and Non-Applicability
134(1)
12.11 Document Control
134(1)
12.12 Record Completion and Control
135(1)
12.13 Management Responsibility
135(1)
12.14 Resource Management
136(1)
12.15 Product Realisation
136(1)
12.16 Risk Management
136(1)
12.17 Design and Development
137(1)
12.18 Purchasing and Supplier Control
138(1)
12.19 Production and Service Provision
138(1)
12.20 Monitoring and Measuring, Including Internal Audits and Management Review
139(1)
12.21 Control of Non-Conforming Product
140(1)
12.22 Analysis of Data
140(1)
12.23 Improvement: Corrective Action and Preventive Action
140(1)
12.24 Purpose and Goal of ISO 13485: 2003 Certification
141(1)
12.25 Achieving Certification and Continuing to Maintain Certification
141(4)
13 ISO 14971: Application of Risk Management to Medical Devices
145(20)
Tony Chan
Raymond K. Y. Tong
13.1 Introduction
145(4)
13.2 The Foundation of a Risk Management (RM] Framework: Policy, Plan, Team, Process, and Documentation
149(1)
13.2.1 Policy
149(1)
13.2.2 Plan
149(1)
13.2.3 Team
149(1)
13.2.4 Process
150(1)
13.2.5 Documentation
150(1)
13.3 The RM Process
150(4)
13.3.1 Analyze Risk
150(1)
13.3.2 Evaluate Risk
151(1)
13.3.3 Control Risk
151(2)
13.3.4 Feedback from Production and Post-Production Information
153(1)
13.4 Conclusion
154(1)
13.5 Case Study --- An Example to Illustrate Risk Management on a Medical Device: Functional Electrical Stimulation System for Walking
154(11)
13.5.1 Risk Management Process
156(9)
PART 3 HARMONIZATION OF MEDICAL DEVICES IN ASIA
14 Medical Devices in the World Health Organization
165(4)
Adriana Velazquez Berumen
Jack Wong
15 Asian Harmonization Working Party
169(4)
Saleh A.I. Tayyar
15.1 Introduction
169(1)
15.2 Future Directions
170(3)
16 Asia-Pacific Economic Cooperation
173(10)
Lindsay Tao
16.1 Introduction
173(3)
16.1.1 Trade and Investment Liberalization
174(1)
16.1.2 Business Facilitation
175(1)
16.1.3 Economic and Technical Cooperation
175(1)
16.2 APEC LSIF: Life Sciences Innovation Forum (Reports to Committee on Trade and Investment)
176(2)
16.3 APEC LSIF/RHSC: Regulatory Harmonization Steering Committee
178(5)
17 Harmonization of Medical Device in ASEAN
183(8)
Petahn McKenna
17.1 Introduction
183(1)
17.1.1 Medical Device Market in ASEAN
183(1)
17.1.2 Medical Device Regulatory Environment in ASEAN
184(1)
17.2 ASEAN Medical Device Directive and Harmonization
184(7)
17.2.1 Provisions of the AMDD
185(1)
17.2.2 Definition of a Medical Device
186(1)
17.2.3 Medical Device Classification
187(1)
17.2.4 Common Submission Dossier Template
187(1)
17.2.5 Post-Market Alert System
188(1)
17.2.6 AMDD Status
188(1)
17.2.7 Future of ASEAN Harmonization
189(2)
18 Regulatory Affairs Professionals Society
191(8)
Sherry Keramidas
Zachary Brousseau
18.1 Introduction
191(1)
18.2 Importance in Today's Global Environment
192(1)
18.3 The Global Regulatoty Community
193(1)
18.4 Building Knowledge and Competencies
194(1)
18.5 The RAC Credential
195(1)
18.6 Professional Knowledge and Standards
196(1)
18.7 News and Information
197(2)
19 Expediting Innovation in Singapore with Regulatory Knowledge
199(12)
Patricia Ho
Jui Lim
19.1 The Biodesign Innovation Process
201(3)
19.1.1 Identify
202(1)
19.1.2 Invent
202(2)
19.1.3 Implement
204(1)
19.2 The Innovator's Resource
204(3)
19.3 Current Direction
207(4)
PART 4 MEDICAL DEVICE REGULATORY SYSTEM IN THE UNITED STATES AND THE EUROPEAN UNION
20 United States Medical Device Regulatory Framework
211(22)
Carole C. Carey
20.1 Introduction
211(2)
20.2 The FDA Center for Devices and Radiological Health
213(1)
20.3 Total Product Life Cycle Approach
213(1)
20.4 Legislation and Device Laws
214(1)
20.4.1 FDA Law vs. FDA Regulations vs. FDA Guidance
215(1)
20.5 The Regulatory Environment for Bringing a Medical Device to Market
215(1)
20.6 Regulatory Considerations to Market and Keep Devices in Distribution
216(13)
20.6.1 Definition of Medical Devices
216(1)
20.6.2 Classification of Medical Devices
217(1)
20.6.3 Adulteration and Misbranding
218(1)
20.6.4 Establishment Registration and Medical Device Listing
219(1)
20.6.5 Premarket Notification (510(k))
220(1)
20.6.5.1 Kits
221(1)
20.6.5.2 Predicate device and substantial equivalence
221(2)
20.6.5.3 Planning and assembling the 510(k) submission process
223(2)
20.6.6 Premarket Approval (PMA)
225(1)
20.6.7 Investigational Device Exemption (IDE)
226(1)
20.6.8 Labeling
226(1)
20.6.9 Quality System (QS) Regulation/Good Manufacturing Practices (GMP)
227(1)
20.6.10 Medical Device Reporting (MDR)
227(1)
20.6.11 User Fees
228(1)
20.7 Summary
229(4)
21 European Union: Medical Device Regulatory System
233(42)
Patricia Teysseyre
21.1 Glossary of Terms
233(1)
21.2 Europ'ean Union: History and Structure
234(1)
21.3 New Approach --- Global Approach Concepts
235(4)
21.4 Harmonized Standards and Presumption of Conformity
239(4)
21.5 European Associations
243(1)
21.6 Overview of Medical Devices Directives
243(1)
21.7 Guidelines
244(1)
21.8 Definitions
245(4)
21.8.1 Medical Device
245(1)
21.8.2 CE Mark
245(1)
21.8.3 Competent Authority
246(1)
21.8.4 Notified Body: Conformity Assessment Body
247(1)
21.8.5 Legal Manufacturer
248(1)
21.8.6 Authorized Representative
249(1)
21.9 Classification
249(3)
21.9.1 Medical Devices
249(1)
21.9.2 Active Implantable Medical Devices
250(1)
21.9.3 In vitro and Diagnostics Medical Devices
251(1)
21.10 Conformity Assessment Procedures
252(3)
21.11 Essential Requirements
255(2)
21.12 Labelling
257(1)
21.13 Technical Documentation
258(1)
21.14 Quality Management System
258(6)
21.15 Risk Management
264(1)
21.16 Clinical Evaluation
264(2)
21.17 CE Mark Certificate and Declaration of Conformity
266(1)
21.18 Post-Market Surveillance
267(1)
21.19 Recent Changes of MDD 93/42/EEC and Impacts
268(2)
21.20 Trends
270(1)
21.21 Overview of All Interactions and Key Terminology
271(4)
22 Regulation of Combination Products in the United States
275(12)
John Barlow Weiner
Thinh X. Nguyen
22.1 Introduction
275(1)
22.2 What Products Are Considered Combination Products
276(1)
22.3 The Standards for Determining If a Product Is a Combination Product
276(1)
22.4 The Standards for Determining Which FDA Component has Primary Responsibility for Regulating a Combination Product
277(3)
22.5 Requests for Designation
280(1)
22.6 Premarket Review Considerations
280(1)
22.7 Post-Market Regulatory Considerations
281(1)
22.8 Role of Office of Combination Products
282(2)
22.9 Near-Term Developments That May Arise in the US
284(1)
22.10 International Harmonization and Coordination Activities with Foreign Counterparts
284(1)
22.11 FDA Resources for Obtaining Additional Information
285(2)
23 Regulation of Combination Products in the European Union
287(14)
Janine Jamieson
Elizabeth Baker
23.1 Introduction: Legal Basis
287(4)
23.1.1 Definitions
288(1)
23.1.1.1 Medical device
288(1)
23.1.1.2 Medicinal product
289(1)
23.1.1.3 Combination products: Principal mode of action
290(1)
23.1.1.4 Borderline products: MEDDEV 2.1/3
291(1)
23.1.1.5 Borderline products: Manual of decisions
291(1)
23.2 Combination Products Regulated as Medicinal Products
291(1)
23.2.1 Examples of Combination Products Regulated as Medicinal Products
292(1)
23.3 Combination Products Regulated as Medical Devices
292(1)
23.3.1 Examples of Combination Products Regulated as Drug-Delivery Devices
292(1)
23.4 Combination Products Regulated as Devices Incorporating, as an Integral Part, an Ancillary Medicinal Substance
293(1)
23.4.1 Examples of Devices Incorporating an Ancillary Medicinal Substance
293(1)
23.4.2 Examples of Drug Substances Incorporated into Devices
294(1)
23.4.3 Assessment of the Medicinal Substance Aspects of a Device Incorporating an Ancillary Medicinal Substance
294(1)
23.5 The Consultation Process
294(1)
23.6 Information to Be Provided on the Ancillary Medicinal Substance
295(2)
23.6.1 General
295(1)
23.6.2 Quality, Safety, Usefulness (Clinical Benefit/Risk)
295(1)
23.6.2.1 Quality
295(1)
23.6.2.2 Safety and usefulness (clinical benefit/risk)
296(1)
23.6.2.3 Guidance
296(1)
23.7 Other Combination Products
297(4)
PART 5 MEDICAL DEVICE REGULATORY SYSTEM IN ASIA-PACIFIC REGION
24 Australian Medical Device Regulations: An Overview
301(16)
Petahn McKenna
24.1 Introduction
301(1)
24.1.1 Medical Device Market in Australia
301(1)
24.2 Medical Device Regulations
302(1)
24.2.1 Overview
302(1)
24.2.2 Regulating Authority
303(1)
24.2.3 Legislation and Guidance
303(1)
24.3 Definition of Medical Device
303(1)
24.4 Classification of Medical Devices
304(2)
24.4.1 Classification of IVD Medical Devices
304(2)
24.5 Inclusion of Medical Devices on the ARTG
306(6)
24.5.1 Process for Supplying a Medical Device in Australia
306(1)
24.5.2 Process for Including Class 1 IVD Medical Devices (Other Than Export Only) in the ARTG
307(3)
24.5.3 Process for Including IVD Medical Devices (Other Than Class 1) in the ARTG
310(2)
24.6 Same Kind of Medical Device (SKMD)
312(1)
24.7 Unique Product Identifier
312(1)
24.8 In vitro Diagnostic UPIs
313(1)
24.9 Renewal
314(1)
24.10 Documentation Requirements
314(1)
24.10.1 Conformity Assessment Applications
314(1)
24.11 Application Audits
315(1)
24.12 Access to Unapproved Medical Devices
316(1)
25 China: Medical Device Regulatory System
317(14)
Jack Wong
25.1 Introduction
317(1)
25.2 Market Overview
318(1)
25.3 Overview of Regulatory Environment and What Laws/Regulations Govern the Medical Devices
318(2)
25.3.1 Measuring Function
319(1)
25.3.2 Standards
319(1)
25.4 Regulatory Body
320(1)
25.5 Regulatory Overview
321(7)
25.5.1 Definition of Medical Device
321(1)
25.5.2 Classification of Medical Device
321(1)
25.5.3 Registration Process
322(1)
25.5.3.1 Medical devices registration certificate
322(1)
25.4.5.2 Product testing
323(1)
25.5.3.3 Clinical trials
324(1)
25.5.3.4 Exemption of clinical trial data for Class II devices
325(1)
25.5.3.5 Enforcing GMPs
325(1)
25.5.3.6 Timeframes
326(1)
25.5.3.7 The CCC mark
327(1)
25.6 Monitoring Adverse Events
328(1)
25.7 Managing Recalls
329(2)
26 Hong Kong: Medical Device Regulatory System
331(10)
Jack Wong
26.1 Market Overview
331(1)
26.1.1 Market Environment
331(1)
26.2 Overview of Regulatory Environment and What Laws/Regulations Govern Medical Devices
332(1)
26.3 Regulatory Body
333(2)
26.4 Regulatory Overview
335(4)
26.4.1 Definition of Medical Device (It Follows GHTF)
334(1)
26.4.2 The Classification of Medical Devices
335(1)
26.4.3 Role of Distributors or Local Subsidiaries
336(1)
26.4.4 Product Registration or Conformity Assessment Route and Time Required
337(1)
26.4.4.1 Suggested registration routes/steps
338(1)
26.4.4.2 Technical material requirement
338(1)
26.4.4.3 The labelling requirement of medical device
338(1)
26.4.4.4 Post-marketing surveillance requirement
338(1)
26.4.4.5 Manufacturing-related regulation: Do manufacturers need registration/authorization?
339(1)
26.4.4.6 Clinical trial-related regulation: Are medical device clinical trials regulated?
339(1)
26.4.4.7 Is there a procedure for mutual recognition of foreign marketing approval or international standards?
339(1)
26.5 Commercial Aspect
339(1)
26.6 Next Steps
340(1)
27 India: Medical Device Regulatory System
341(24)
Kulwant S. Saini
27.1 Market Overview
341(11)
27.1.1 Market Environment
341(1)
27.1.2 Overview of Regulatory Environment and What Laws/Regulations Govern Medical Devices
342(4)
27.1.3 Functions Undertaken by DCGI and Central Government
346(1)
27.1.3.1 Statutory functions
346(1)
27.1.3.2 Other functions
346(1)
27.1.4 Functions Undertaken by the FDA and State Governments
347(1)
27.1.4.1 Statutory functions
347(1)
27.1.5 Guidance Documents
348(1)
27.1.6 Indian Pharmacopoeial Commission
349(1)
27.1.7 Detail of Key Regulator(s)
349(3)
27.2 Regulatory Overview
352(9)
27.2.1 Definition of Medical Device
352(1)
27.2.2 Classification of Medical Device
353(1)
27.2.3 Role of Distributors or Local Subsidiaries (LRP)
353(1)
27.2.4 Product Registration or Conformity Assessment Route and Time Required
354(2)
27.2.5 Quality System Regulation
356(1)
27.2.6 Product Registration and Quality System Regulation for Combined Device-Drug Product
356(1)
27.2.7 Registration Fee
356(1)
27.2.8 Technical Material Requirement
357(1)
27.2.9 The Labelling Requirement of Medical Device
358(1)
27.2.10 Post-Marketing Surveillance Requirement
359(1)
27.1.11 Manufacturing-Related Regulation
359(1)
27.1.12 Clinical Trial-Related Regulation
360(1)
27.1.13 Is There a Procedure for Mutual Recognition of Foreign Marketing Approval or International Standards?
361(1)
27.3 Commercial Aspect
361(1)
27.3.1 Any Price Control of Medical Device
361(1)
27.3.2 Are Parallel Imports Allowed?
362(1)
27.3.3 Any Advertisement Regulation of Medical Device?
362(1)
27.4 Upcoming Regulation Changes
362(1)
27.5 Related Agencies/Departments and Ministries
363(2)
28 Indonesia: Medical Device Regulatory System
365(22)
Mita Rosalind
28.1 Introduction
365(2)
28.2 Regulating Authority
367(1)
28.3 Definition of Medical Device
367(1)
28.4 Classification of Medical Devices
368(1)
28.5 Registration of Medical Devices
369(3)
28.5.1 Process
368(2)
28.5.2 Documents Required
370(1)
28.5.3 Official Registration Fee
370(1)
28.5.4 Time Line
370(1)
28.5.5 Validity of Product License
371(1)
28.5.6 Indonesian Labeling Requirement
371(1)
28.5.7 Regulatory Action for Changes and Device Modifications
371(1)
28.6 Post Market Surveillance System
372(15)
29 Japan: Medical Device Regulatory System
387(16)
Atsushi Tamura
29.1 Introduction
387(1)
29.2 Regulatory Agency in Japan
388(3)
29.2.1 The Ministry of Health, Labour and Welfare
388(1)
29.2.2 Pharmaceuticals and Medical Devices Agency
388(1)
29.2.3 Shared Responsibility of MHLW and PMDA on Medical Device Regulation
388(3)
29.3 Legislation of Medical Devices
391(5)
29.3.1 Classification of Medical Devices
392(1)
29.3.2 Type of Product's Registration
393(1)
29.3.2.1 Notification
393(1)
29.3.2.2 Pre-market certification (third-party certification)
393(1)
29.3.2.3 Pre-market approval
394(1)
29.3.3 Marketing Authorization Holder
394(1)
29.3.4 Manufacturer License (Art. 13)/ Accreditation of Foreign Manufacturer (Art. 13-3)
394(2)
29.4 Related Requirements
396(1)
29.4.1 Quality Management System
396(1)
29.4.1.1 QMS conformity as an essential requirement
396(1)
29.4.1.2 QMS inspections
397(1)
29.4.2 Good Quality Practices
397(1)
29.5 MAH'S Obligations during Post-Market Phase
397(3)
29.5.1 Collection, Analysis and Reporting of Safety Information
399(1)
29.5.2 Recall
399(1)
29.5.3 Post-Marketing Safety Management
400(1)
29.6 PMDA's Obligations during Post-Market Phase
400(3)
29.6.1 New Challenge
401(1)
29.6.2 Information Services
401(2)
30 Jordan: Medical Device Regulatory System
403(18)
Anan Abu Hassan
30.1 Jordan Food and Drug Administration: Introduction
403(1)
30.1.1 Vision
403(1)
30.1.2 Mission
404(1)
30.1.3 Overview of Structure of Jordan Food and Drug Administration
404(1)
30.2 Medical Device Market in Jordan
404(1)
30.3 Overview of Regulatory Environment and What Laws/Regulations Govern the Medical Devices
404(5)
30.4 Data about Jordan
409(1)
30.5 Price Control of Medical Device
409(1)
30.6 Priorities
409(12)
31 Republic of Korea (South Korea): Medical Device Regulatory System
421(24)
Peter Lee
31.1 Market Overview
421(3)
31.1.1 Facts about South Korea
421(1)
31.1.2 Medical Device Market Scale in South Korea
422(1)
31.1.3 Definition of Medical Device
422(1)
31.1.4 Detail of Key Regulator
423(1)
31.2 Introduction to Korea Medical Device Regulatory System
424(15)
31.2.1 History
424(1)
31.2.2 Procedures
425(1)
31.2.3 KGMP: Quality Management System
426(3)
31.2.4 Product Notification: Class I Devices
429(1)
31.2.5 Product License: Class II, III, and IV Devices
430(1)
31.2.6 Technical File
430(1)
31.2.7 Clinical Trials
431(1)
31.2.8 Device Notification/License
432(1)
31.2.9 Technical File Review
433(1)
31.2.10 Type Testing (Mandatory for Class II, III, and IV Devices)
434(2)
31.2.11 KFDA-Registered 13 Laboratories
436(1)
31.2.12 Applying for a Product License
437(1)
31.2.13 Business License
437(1)
31.2.14 Audit of Quality Management System (KGMP Certification)
438(1)
31.2.15 Post-Market Surveillance System
438(1)
31.3 Importer's Note
439(6)
31.3.1 Import Labelling
439(1)
31.3.2 Import Packaging
439(1)
31.3.3 Import Documentation
439(1)
31.3.4 Other Agencies
440(1)
31.3.5 Medical Device Advertisements
441
31.3.6 Contacts
439(6)
32 Malaysia: Medical Device Regulatory System
445(12)
Yean Ting Ong
32.1 Market Overview
445(1)
32.2 Regulating Authority
446(1)
32.3 Definition of Medical Device
447(1)
32.4 Classification of Medical Devices
447(2)
32.5 Registration of Medical Devices
449(4)
32.5.1 Market Environment
450(1)
32.5.2 Conformity Assessment Process
451(2)
32.5.3 Combination Products
453(1)
32.6 Post-Market Surveillance and Vigilance
453(2)
32.6.1 Mandatory Reporting
453(1)
32.6.2 Field Corrective Action
454(1)
32.6.3 Recall
454(1)
32.6.4 Labeling
455(1)
32.7 Regulatory Action for Changes and Device Modifications
455(2)
33 Philippines: Medical Device Regulatory and Licensing
457(12)
Mary Claire Cacanindin
Jennifer Cheah
33.1 Market Overview
457(1)
33.2 Regulatory Overview
458(2)
33.3 History of Medical Device Regulation
460(1)
33.4 Regional Medical Device Harmonization under Development through ASEAN
461(1)
33.5 Definition of Medical Device in Philippines
462(1)
33.6 Registration with BEAD
463(3)
33.6.1 License to Operate
463(1)
33.6.2 License to Operate: Requirements
464(1)
33.6.3 Certificate of Product Registration
465(1)
33.6.4 Certificate of Product Registration: Technical Requirements
465(1)
33.6.5 Certificate of Product Registration: Legal Requirements
466(1)
33.7 Import Labeling
466(1)
33.8 Import Documentation
467(1)
33.9 Summary of Regulatory System
467(1)
33.10 Contacts
468(1)
34 Saudi Arabia: Medical Device Regulation System
469(18)
Ali M. Al Dalaan
34.1 Introduction
469(1)
34.2 Legislative Responsibilities
470(1)
34.3 Executive Responsibilities
470(1)
34.4 Surveillance Responsibilities
471(1)
34.5 Regulation Overview
472(1)
34.6 Registration Requirements
473(1)
34.7 Information to Be Provided to SFDA
473(3)
34.8 Medical Device Marketing Authorization (MDMA)
476(2)
34.9 Medical Device Listing
478(1)
34.10 Registration Fees
478(2)
34.11 General Information and Documentary Evidence to Be Provided to SFDA
480(1)
34.12 Labeling Requirement for Medical Device
481(1)
34.13 Post-Market Surveillance Requirement
481(6)
35 Singapore: Medical Device Regulatory System
487(26)
Lee Ching Hwee
35.1 Market Overview Introduction: An Explanation of the Process and Approach
487(4)
35.1.1 Market Environment
487(1)
35.1.2 Overview of Regulatory Environment and What Laws/Regulations Govern Medical Devices
488(1)
35.1.2.1 Phase I implementation
489(1)
35.1.2.2 Phase II implementation
489(1)
35.1.2.3 Phase III implementation
489(2)
35.2 Detail of Key Regulator(s)
491(1)
35.3 Regulatory Overview
492(2)
35.3.1 The Definition of Medical Device
492(1)
35.3.2 Classification of Medical Devices (Classes A, B, C, and D)
493(1)
35.3.2.1 Principle
493(1)
35.3.2.2 Classification
493(1)
35.3.2.3 Determination
494(1)
35.4 Product Grouping
494(2)
35.4.1 Single
494(1)
35.4.2 Family
495(1)
35.4.3 System
495(1)
35.4.4 Group
496(1)
35.4.5 IVD Cluster
496(1)
35.5 Product Registration and Time Required
496(3)
35.5.1 Application Process: Product Registration for Higher Risk Medical Devices (Class B, C, and D)
496(1)
35.5.2 Product Registration for Lower Risk Medical Devices (Class A)
497(1)
35.5.3 Evaluation Routes
498(1)
35.6 Product Registration for Combined Device-Drug Product
499(1)
35.7 Application Fee
499(1)
35.8 Technical Material Requirement
499(2)
35.9 Labeling Requirement of Medical Devices
501(1)
35.10 Post-Marketing Surveillance Requirement
502(1)
35.11 Manufacturing-, Importing-, and Wholesaling - Related Regulation
503(1)
35.12 Good Distribution Practice for Medical Devices
504(1)
35.13 Clinical Trial-Related Regulation
504(1)
35.14 Special Access
505(1)
35.15 Commercial Aspect
506(1)
35.15.1 Any Price Control of Medical Device
506(1)
35.15.2 Are Parallel Imports Allowed?
506(1)
35.15.3 Any Advertisement Regulation of Medical Device?
507(1)
35.16 Upcoming Regulatory Implementation
507(6)
35.16.1 Regulatory Framework for Cell- and Tissue-Based Therapeutic Products
507(6)
36 Taiwan: Medical Device Regulatory System
513(12)
Li-Ling Liu
36.1 Market Overview
513(4)
36.1.1 Overview of Structure and Funding of Local Healthcare System
513(2)
36.1.2 Overview of Regulatory Environment and Laws/Regulations Governing Medical Devices
515(2)
36.1.3 Detail of Key Regulator(s)
517(1)
36.2 Regulatory Overview
517(2)
36.2.1 Definition of Medical Device
517(1)
36.2.2 Classification of Medical Device
517(1)
36.2.3 Role of Distributors or Local Subsidiaries
518(1)
36.2.4 Products Registration, Technical Material Requirement, and Time Required
518(1)
36.3 Quality System Regulation
519(1)
36.4 Combined Device-Drug Product
520(1)
36.5 Registration Fee
520(1)
36.6 Labeling Requirements of Medical Devices
520(1)
36.7 Any Post-Marketing Surveillance Requirement
521(1)
36.8 Manufacturing-Related Regulation
521(1)
36.9 Clinical Trial-Related Regulation
521(1)
36.10 International Cooperation
522(1)
36.11 Commercial Aspects
522(3)
36.11.1 Price Control of Medical Device
522(1)
36.11.2 Parallel Imports
523(1)
36.11.3 Any Advertisement Regulation of Medical Devices?
523(2)
37 Thailand: Regulatory and Medical Device Control
525(10)
Patanawong Yuwadee
37.1 Market Overview
525(1)
37.2 Medical Device Regulations and Regulators
526(1)
37.3 Definition of a Medical Device
527(2)
37.4 Classification of Medical Devices
529(1)
37.5 Product Registration
529(3)
37.5.1 Licensed Medical Devices and Notified Medical Devices
529(1)
37.5.2 General Medical Devices
530(1)
37.5.3 Review Period (as Promulgated in 2012)
531(1)
37.5.4 Fees and Validity of Granting or Issued Document
532(1)
37.6 Labeling
532(1)
37.7 Advertisement Control
533(2)
38 UAE: Overview of Medical Device/IVD Regulatory System
535(12)
Amin Al Amiri
38.1 Ministry of Health
535(2)
38.1.1 Registration and Drug Control Department
535(1)
38.1.2 Mission Statement
536(1)
38.1.3 Medical Device Registration
536(1)
38.2 Introduction to MD/IVD Regulatory System in UAE
537(1)
38.3 Medical Devices Marketing Approval Flow Chart
538(1)
38.4 Approval on Importation Level
539(1)
38.5 Definition of a Medical Device
540(1)
38.6 Classification of Medical Device/IVD
540(1)
38.7 Authorized Representative Concept
541(1)
38.8 Company Registration
542(1)
38.8.1 Medical Devices Classified as Nonpharmaceutical Dosage Form
542(1)
38.8.2 Medical Devices Classified as Containing Pharmaceutical Ingredients
543(1)
38.9 Product Registration
543(3)
38.9.1 Medical Devices Subject for Listing
543(1)
38.9.2 Product Registration: Main Documents
544(1)
38.9.3 Required Attachments per Device Class
545(1)
38.10 Pricing
546(1)
38.11 Parallel Importation
546(1)
39 Vietnam: Medical Device Regulatory System
547(8)
Thuy Nguyen Thi Thu
39.1 Market Overview
547(1)
39.2 Overview of Regulatory Environment and Laws/Regulations Governing Medical Devices
548(1)
39.2.1 Detail of Key Regulator(s)
548(1)
39.3 Regulatory Overview
549(1)
39.3.1 Definition of Medical Device
549(1)
39.4 Classification of Medical Devices (Class A, B, C, D)
550(1)
39.5 Role of Distributors or Local Subsidiaries
550(1)
39.6 Product Registration or Conformity Assessment Route and Time Required
550(3)
39.6.1 Quality System Regulation
551(1)
39.6.2 Product Registration and Quality System Regulation for Combined Device-Drug Product
551(1)
39.6.3 Registration Fee
551(1)
39.6.4 Technical Material Requirement
552(1)
39.6.5 Labeling Requirements for Medical Devices
552(1)
39.6.6 Post-Marketing Surveillance Requirement
552(1)
39.6.7 Manufacturing-Related Regulation
552(1)
39.6.8 Clinical Trial-Related Regulation
552(1)
39.6.9 Is There a Procedure for Mutual Recognition of Foreign Marketing Approval or International Standards?
552(1)
39.7 Commercial Aspects
553(1)
39.7.1 Any Control over Prices of Medical Devices?
553(1)
39.7.2 Are Parallel Imports Allowed?
553(1)
39.7.3 Any Regulation Regarding Advertisement of Medical Devices?
553(1)
39.8 Upcoming Events
553(2)
Appendix 555(20)
Index 575
Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007.
Biežāk uzdotie jautājumi par e-grāmatām Biežāk uzdotie jautājumi par e-grāmatām
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