Regulatory and Reimbursement Scenario of Robotic-Assisted Surgery

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REGULATORY AND REIMBURSEMENT SCENARIO OF
ROBOTIC-ASSISTED
SURGERY
Strategic Series MARCH 2020 TOC
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Table of Content
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Executive Summary
1
08
Product Definition
1.1 Criteria for Exclusions 08
2
09
Scope of the Study
2.1 Key Questions to be Answered 09
10
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Research Methodology
3.1 Criteria for Selection of Countries 10
Figure 3.1 Global Surgical Robotics Market, 2018 - 2029 10
Figure 3.2 Market Share of Top 10 Countries in the Global Surgical Robotics Market, 2018 and 2029
Market Share of Top 10 Countries in the Global Surgical Robotics Market, 2018 and 2029 11
3.2 Data Sources 12
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13
Introduction
4.1 Entry of Surgical Robots in the Market 14
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North America
5.1 U.S. 15
5.1.1 Regulatory Scenario in U.S. 15
5.1.1.1 Food and Drug Administration (FDA) and Classification of Medical Devices
Food and Drug Administration (FDA) and Classification of Medical Devices 15
Figure 5.1 Regulatory Process for Medical Devices in the U.S. 16
5.1.1.2 Groups Ensuring Regulations and Safety of Surgical Robots
Groups Ensuring Regulations and Safety of Surgical Robots 18
5.1.1.3 Training requirements in the U.S for Performing Robot- Assisted Surgeries (RAS)
Training requirements in the U.S for Performing Robot- Assisted Surgeries (RAS) 20
5.1.2 Reimbursement Scenario in the U.S. 21
5.1.2.1 Documentation 23
5.1.2.2 Coverage for Use of Robotic Technique Within the Policies of Major Private Health Insurance Providers in the U.S.
Coverage for Use of Robotic Technique Within the Policies of Major Private Health Insurance Providers in the U.S. 23
5.1.3 Conclusion 24
5.2 Canada 24
5.2.1 Regulatory Scenario in Canada 24
5.2.2 Reimbursement Scenario in Canada 25
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5.2.2.1 Key Stakeholders in the Canadian Reimbursement Process 26
5.2.2.2 Reimbursement for Medical 26
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Asia-Pacific
6.1 Japan 27
6.1.1 Regulatory Scenario in Japan 27
6.1.1.1 Regulatory Pathway for Medical 27
6.1.1.2 Structure of Healthcare System in Japan 28
6.1.2 Reimbursement Scenario in Japan 29
6.1.2.1 Reimbursment of daVinci Surgical Robotic Systems in Japan
Reimbursment of daVinci Surgical Robotic Systems in Japan 29
6.2 China 30
6.2.1 Regulatory Scenario in China 30
6.2.1.1 Classification of Medical Devices in China 31
6.2.1.2 Regulatory Changes in China 31
6.2.1.3 The Market Access Process For Imported Medical Devices
The Market Access Process For Imported Medical Devices 32
6.2.2 Reimbursement Scenario in China 33
6.2.2.1 Provincial Reimbursement Issues 33
6.3 Australia 33
6.3.1 Regulatory Scenario in Australia 33
Table 6.1 The TGA Medical Device Classification System 34
6.3.1.1 Lifecycle of Regulations by TGA 34
6.3.1.2 Post-market Regulations 34
6.3.1.3 Adverse Event and Incident Reporting 34
6.3.2 Reimbursement Scenario in Australia 35
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European Union
7.1 Regulatory Scenario in European Union 36
Figure 7.1 MDR Transitional Provisions (EU) 37
Figure 7.2 Conformity Assessment Routes for Class IIb Medical Devices
Conformity Assessment Routes for Class IIb Medical Devices 39
7.1.1 Changes in Rule 40
7.1.2 New Rules in the Annexure VIII 40
7.1.2.1 Expanded Device Definitions Requiring Reexamination of Current Classification of all Devices
Expanded Device Definitions Requiring Reexamination of Current Classification of all Devices 40
7.1.2.2 Quality Management System 40
7.1.2.3 Technical File 40
7.1.2.4 Need to Comply with New Identification and Traceability (UDI) Requirements
Need to Comply with New Identification and Traceability (UDI) Requirements 41
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7.1.2.5 More Emphasis on Post Market Surveillance 41
7.1.2.6 Role of Internal Audits and Requirement of Audits Strengthened
Role of Internal Audits and Requirement of Audits Strengthened 41
7.1.2.7 Dedicated Personal for MDR 41
7.2 Reimbursement Scenario in European Union 42
7.2.1 France 42
Figure 7.3 France Reimbursement System 42
7.2.2 Germany 43
Figure 7.4 German Reimbursement System 44
7.2.3 U.K. 45
7.2.3.1 Multiple Technology Appraisal 45
7.2.3.2 Single Technology Appraisal (STA) 45
Figure 7.5 Reimbursement System in the U.K. 46
7.2.4 Italy 46
Figure 7.6 Reimbursement System in Italy 47
7.2.5 Spain 47
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Robotic Surgery Regulatory and Reimbursement
Scenario March 2020
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