Abbreviations and Acronyms
Disclaimer
Preface
Executive Summary

1. New Health Technology Assessment (nHTA)
   1.1. Key Features of National Health Insurance System
   1.2. Definition and Eligibility of nHTA
   1.3. Evolution of nHTA
   1.4. Clinical Adoption of nHTA
   1.5. nHTA Result Classification

2. Access-First System for Health Technology
   2.1. Postponement of nHTA
      2.1.1. Eligibility
      2.1.2. Path
      2.1.3. Processing Time
   2.2. Innovative Medical Technology Assessment
      2.2.1. Eligibility
   2.3. Limited Medical Technology Assessment
      2.3.1. Eligibility
      2.3.2. Path
      2.3.3. Processing Time

3. Innovative Medical Technology System
   3.1. Definition
      3.1.1. Innovative Medical Technology vs. Innovative Medical Devices
   3.2. Evolution of Innovative Medical Technology Assessment
   3.3. Innovative Medical Technology Path
      3.3.1. Application Phase
      3.3.2. Review Phase
      3.3.3. Selection and Notification Phase
      3.3.4. Use Reporting Phase
      3.3.5 Reassessment Phase

4. Current State of Innovative Medical Technology
   4.1. Innovative Medical Technology Applications
   4.2. Designation and Notification
   4.3. Examples of Non-Innovative Medical Technology Cases

5. Market Access Strategies Leveraging Innovative Medical Technology Assessment
   5.1. Eligibility of Innovative Medical Technology Assessment
   5.2. Eligibility of Integrated Assessment
   5.3. Clinical Evidence Requirements
   5.4. Strategies for Potential Assessment Report Writing
   5.5. Medical Institution Arrangement for Post-Notification Usage
   5.6. Patient Registration and Reimbursement Application
   5.7. Reassessment of Innovative Medical Technology

[Table 1] Evolution of nHTA
[Table 2] Comparison of Access-First System Process
[Table 3] Changes in Postponement of nHTA System
[Table 4] Innovative Medical Technology vs. Innovative Medical Device
[Table 5] Revised Regulations on Innovative Medical Technology and its Implementation
[Table 6] Innovative Medical Technology Review and Potential Assessment Criteria
[Table 7] Innovative Medical Technology Applications Year-by-Year
[Table 8] Innovative Medical Technology Results
[Table 9] Innovative Medical Technology Notifications
[Table 10] Innovative Medical Technology Review and Potential Assessment Criteria
[Table 11] Non-Innovative Cases of Innovative Medical Technology Assessment System
[Table 12] Pros and Cons of Market Access Strategy Leveraging Innovative Medical Technology Assessment
[Table 13] Integrated Assessment Criteria
[Table 14] General Review Criteria for Innovative Medical Technology
[Table 15] General Potential Assessment Opinion Letter Highlights
[Table 16] Innovative Medical Device and Technology Scorecard Highlights
[Table 17] Integrated Review Potential Assessment Opinion Letter Highlights
[Table 18] Reimbursement Application Documentation

[Fig 1] nHTA Eligibility
[Fig 2] Clinical Adoption of nHTA
[Fig 3] Examples of nHTA Safety and Effectiveness Result Notification
[Fig 4] nHTA Report Example
[Fig 5] nHTA Postponement Flowchart
[Fig 6] Evolution of Innovative Medical Assessment Process
[Fig 7] Limited Medical Technology Assessment Result Notification Example
[Fig 8] Limited Medical Technology Assessment Process Flowchart
[Fig 9] Evidence Generation Period (both state-funded and non-funded)
[Fig 10] Innovative Medical Device Group Designation and Classification
[Fig 11] Separate Assessment Track Pilot Program
[Fig 12] Pilot Program vs. Full-Scale Program
[Fig 13] Evolution of Innovative Medical Assessment Process
[Fig 14] Innovative Medical Technology Assessment Process Flowchart
[Fig 15] Opinion Letter on Medical Technology Potential
[Fig 16] Innovative Medical Technology Assessment Result Notification Sample
[Fig 17] Innovative Medical Technology Implementation Flowchart
[Fig 18] Innovative Medical Technology Applications
[Fig 19] Innovative Medical Technology Assessment Market Access Paths
[Fig 20] Innovative Medical Technology Integrated Review System Flowchart
[Fig 21] Reimbursement Application of AI-Enabled Innovative Medical Technology
[Fig 22] Temporary Reimbursement Sample of Innovative Medical Technology