Regulatory and Reimbursement Scenario of Robotic-Assisted Surgery

Published Year: 2020


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Table of Contents

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1 Product Definition

1.1   Criteria for Exclusions

2 Scope of the Study

2.1   Key Questions to be Answered

3 Research Methodology

3.1   Criteria for Selection of Countries
3.2   Data Sources

4 Introduction

4.1    Entry of Surgical Robots in the Market

5 North America

5.1   U.S.
        5.1.1   Regulatory Scenario in U.S.
            Food and Drug Administration (FDA) and Classification of Medical Devices
           Groups Ensuring Regulations and Safety of Surgical Robots
            Training requirements in the U.S for Performing Robot- Assisted Surgeries (RAS)
        5.1.2   Reimbursement Scenario in the U.S.
            Coverage for Use of Robotic Technique Within the Policies of Major Private Health Insurance Providers in the U.S.
        5.1.3   Conclusion
5.2   Canada
        5.2.1   Regulatory Scenario in Canada
        5.2.2   Reimbursement Scenario in Canada
            Key Stakeholders in the Canadian Reimbursement Process
            Reimbursement for Medical

6 Asia-Pacific

6.1   Japan
        6.1.1   Regulatory Scenario in Japan
            Regulatory Pathway for Medical
            Structure of Healthcare System in Japan
        6.1.2   Reimbursement Scenario in Japan
            Reimbursment of daVinci Surgical Robotic Systems in Japan
6.2   China
        6.2.1   Regulatory Scenario in China
            Classification of Medical Devices in China
            Regulatory Changes in China
           The Market Access Process For Imported Medical Devices
        6.2.2   Reimbursement Scenario in China
            Provincial Reimbursement Issues
6.3   Australia
        6.3.1   Regulatory Scenario in Australia
            Lifecycle of Regulations by TGA
            Post-market Regulations
            Adverse Event and Incident Reporting
        6.3.2   Reimbursement Scenario in Australia

7 European Union

7.1    Regulatory Scenario in European Union
         7.1.1    Changes in Rule
         7.1.2    New Rules in the Annexure VIII
              Expanded Device Definitions Requiring Reexamination of Current Classification of all Devices
              Quality Management System
              Technical File
              Need to Comply with New Identification and Traceability (UDI) Requirements
              More Emphasis on Post Market Surveillance
              Role of Internal Audits and Requirement of Audits Strengthened
              Dedicated Personal for MDR
7.2   Reimbursement Scenario in European Union
        7.2.1   France
        7.2.2   Germany
        7.2.3   U.K.
            Multiple Technology Appraisal
            Single Technology Appraisal (STA)
        7.2.4   Italy
        7.2.5   Spain

List of Table

Table 6.1   The TGA Medical Device Classification System

List of Figures

Figure 3.1   Global Surgical Robotics Market, 2018 - 2029
Figure 3.2   Market Share of Top 10 Countries in the Global Surgical Robotics Market, 2018 and 2029
Figure 5.1   Regulatory Process for Medical Devices in the U.S.
Figure 7.1   MDR Transitional Provisions (EU)
Figure 7.2   Conformity Assessment Routes for Class IIb Medical Devices
Figure 7.3   France Reimbursement System
Figure 7.4   German Reimbursement System
Figure 7.5   Reimbursement System in the U.K.
Figure 7.6   Reimbursement System in Italy

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Regulatory and Reimbursement Scenario of Robotic-Assisted Surgery