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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Section I: North America: United States and Canada
Chapter 1 Postmarket Compliance and Product Changes: US
Chapter 2 Postmarket Compliance: US
Chapter 3 Postmarket Product Changes: Canada
Chapter 4 Postmarket Compliance: Canada
Chapter 5 Postmarket Surveillance: Canada
Section II: European Union and United Kingdom
Chapter 6 Postmarket Product Changes: EU and UK
Chapter 7 Postmarket Compliance: EU and UK
Chapter 8 Postmarket Surveillance: EU and UK
Section III: Asia-Pacific (APAC)
Chapter 9 Postmarket Product Changes: Japan, China, Australia, New Zealand, and Hong Kong
Chapter 10 Postmarket Compliance: Japan, China, Australia, New Zealand, and Hong Kong
Chapter 11 Postmarket Surveillance: China, Taiwan, and Hong Kong
Chapter 12 Postmarket Surveillance: Japan, South Korea, Australia, and New Zealand
Chapter 13 Postmarket Surveillance: Singapore, Malaysia, and India
Section IV: Latin America (LATAM)
Chapter 14 Postmarket Compliance: Argentina and Chile
Chapter 15 Postmarket Compliance: Brazil, Columbia, Mexico, and Venezuela
Chapter 16 Postmarket Surveillance: Argentina and Chile
Chapter 17 Postmarket Surveillance: Brazil, Colombia, Mexico, and Venezuela
Section V: A Global Perspective on Cybersecurity
Chapter 18 Postmarket Cybersecurity Expectations
Organized into four major regions, including North America (US, Canada), the European Union (EU) and UK, Asia-Pacific (APAC), and Latin America (LATAM), this book focuses on key global markets with an established regulatory system for medical device premarket and postmarket compliance. Each region highlights critical postmarket regulatory requirements, covering postmarket compliance, postmarket product change types and submissions, and postmarket surveillance. The final section examines global postmarket cybersecurity requirements.
This comprehensive overview of global medical device postmarket requirements will be beneficial for both entry-level and seasoned global regulatory affairs professionals and is intended to be a practical reference guide for both industry and academia.