Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

Description

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. Content: Cover Half title Title Copyright Contents Preface Chapter 1. How to Train University Students in Regulatory Affairs 1.1 Introduction 1.2 A Sample of Regulatory Affairs Exercises for Students 1.2.1 Background 1.2.2 Lifelong Learning 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 2.1 Introduction 2.2 Drivers of Change 2.3 Historical Role and Skill Set of a Regulatory Professional. 2.4 Changing Role and Skill Set of the Regulatory Professional2.5 Develop as a Center of Intelligence 2.6 Advance toward Strategic Relationship Management 2.7 Develop as a Strategic Business Partner 2.8 Conclusion: What Will It Take to Get There Chapter 3. The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments 3.1 Introduction 3.2 Key Trends in the Asia Medical Device Industry 3.3 The Role of the Asia RA Team in a Global Medical Device Organization 3.4 Coordination between Commercial Teams and RA Teams. 3.5 The Role of the RA Team during the Different Stages of a Product Life3.5.1 Product Development 3.5.2 Market Introduction 3.5.3 Product Maintenance 3.5.4 Product Phase-Out 3.6 The RA Professional: A Trusted Advisor 3.7 Summary Chapter 4. Commercial Sense and What It Means for a Regulatory Manager or Executive 4.1 Know the Basics 4.1.1 Marketing or Commercial Plan 4.1.2 Priority Products and How They Are Ranked in the Company 4.1.3 Know Your Commercial People 4.2 Maintain a Healthy Communication 4.3 Be Proactive and Part of the Solution. 4.4 Remain the Expert and Provide Clarity to the Organization4.5 Be a Champion for New Product Launches Chapter 5. Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally 5.1 Introduction 5.2 Information in Regulatory Strategy 5.2.1 Device Name 5.2.2 Device Description 5.2.3 Intended Use 5.2.4 Country of Interest 5.2.5 Device Classification 5.2.6 Product Registration or Conformity Assessment Route and Its Approval Timeline 5.2.7 Technical Documentation Requirement 5.2.8 Quality Management System Requirement. 5.2.9 Clinical Assessment5.2.10 Reimbursement Assessment 5.3 Conclusion Chapter 6. Regulatory Affairs as a Business Partner Chapter 7. Introduction to Regulatory Affairs Professionals' Roles Chapter 8. What It Means to Be a Medtech Regulatory Journalist Chapter 9. Affordable Access to Medical Devices in Developing Countries 9.1 Introduction 9.2 Why Is Affordable Access to Medical Devices Important for Developing Countries 9.2.1 Emergency Preparedness 9.2.2 Efficiency and Effectiveness of Health Systems 9.2.3 Health Equity 9.3 Case Studies.