Postmarket Requirements for Medical Devices: A Practical Guide
iii
Table of Contents
Foreword ................................................................................................................................................vii
Preface .....................................................................................................................................................ix
Author Acknowledgments ....................................................................................................................xiii
Section I: North America: United States and Canada.............................................................................1
Chapter 1 Postmarket Compliance and Product Changes: US. ............................................................3
By Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
Chapter 2 Postmarket Compliance: US. .............................................................................................23
By Shikha Malik, MPharm, MS, RAC-Devices
Chapter 3 Postmarket Product Changes: Canada. ..............................................................................47
By Karen Fan, MSc, RAC, PEng, PMP
Chapter 4 Postmarket Compliance: Canada. ......................................................................................59
By Cathy Matthews, MSc
Chapter 5 Postmarket Surveillance: Canada ......................................................................................75
By Karen Zhou, JD, MS, RAC-Devices, RAC-Global
Section II: European Union and United Kingdom. ..................................................................................91
Chapter 6 Postmarket Product Changes: EU and UK .......................................................................93
By Ana Subramanian, MSc, PhD, RAC
Chapter 7 Postmarket Compliance: EU and UK. .............................................................................109
By Echo Yu, MSc, RAC-Global
Chapter 8 Postmarket Surveillance: EU and UK. .............................................................................123
By Ana Subramanian, MSc, PhD, RAC and Barbara Leukers, Dipl. Chem. (FH), RAC
Section III: Asia-Pacific (APAC). ...................................................................................................................137
Chapter 9 Postmarket Product Changes: Japan, China, Australia, New Zealand, and Hong Kong.. 139
By Rajaram Balasubramanian, RAC-US, RAC-EU, PMP and Sharad Mi Shukla, RAC-US,
RAC-EU
Chapter 10 Postmarket Compliance: Japan, China, Australia, New Zealand, and Hong Kong. .........147
By Rajaram Balasubramanian, RAC-US, RAC-EU, PMP and Sharad Mi Shukla, RAC-US,
RAC-EU
Chapter 11 Postmarket Surveillance: China, Taiwan, and Hong Kong............................................... 167
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 12 Postmarket Surveillance: Japan, South Korea, Australia, and New Zealand ...................189
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 13 Postmarket Surveillance: Singapore, Malaysia, and India ................................................217
By Julia Stindl, PhD and Sharon Perez, PhD
iii
Table of Contents
Foreword ................................................................................................................................................vii
Preface .....................................................................................................................................................ix
Author Acknowledgments ....................................................................................................................xiii
Section I: North America: United States and Canada.............................................................................1
Chapter 1 Postmarket Compliance and Product Changes: US. ............................................................3
By Anu Gaur, PhD, MBA, MSRA, RAC-US, RAC-Global
Chapter 2 Postmarket Compliance: US. .............................................................................................23
By Shikha Malik, MPharm, MS, RAC-Devices
Chapter 3 Postmarket Product Changes: Canada. ..............................................................................47
By Karen Fan, MSc, RAC, PEng, PMP
Chapter 4 Postmarket Compliance: Canada. ......................................................................................59
By Cathy Matthews, MSc
Chapter 5 Postmarket Surveillance: Canada ......................................................................................75
By Karen Zhou, JD, MS, RAC-Devices, RAC-Global
Section II: European Union and United Kingdom. ..................................................................................91
Chapter 6 Postmarket Product Changes: EU and UK .......................................................................93
By Ana Subramanian, MSc, PhD, RAC
Chapter 7 Postmarket Compliance: EU and UK. .............................................................................109
By Echo Yu, MSc, RAC-Global
Chapter 8 Postmarket Surveillance: EU and UK. .............................................................................123
By Ana Subramanian, MSc, PhD, RAC and Barbara Leukers, Dipl. Chem. (FH), RAC
Section III: Asia-Pacific (APAC). ...................................................................................................................137
Chapter 9 Postmarket Product Changes: Japan, China, Australia, New Zealand, and Hong Kong.. 139
By Rajaram Balasubramanian, RAC-US, RAC-EU, PMP and Sharad Mi Shukla, RAC-US,
RAC-EU
Chapter 10 Postmarket Compliance: Japan, China, Australia, New Zealand, and Hong Kong. .........147
By Rajaram Balasubramanian, RAC-US, RAC-EU, PMP and Sharad Mi Shukla, RAC-US,
RAC-EU
Chapter 11 Postmarket Surveillance: China, Taiwan, and Hong Kong............................................... 167
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 12 Postmarket Surveillance: Japan, South Korea, Australia, and New Zealand ...................189
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 13 Postmarket Surveillance: Singapore, Malaysia, and India ................................................217
By Julia Stindl, PhD and Sharon Perez, PhD