Global Minimally Invasive Surgical Systems Market – Analysis and Forecast, 2020-2030: Focus on Pro
The Global Minimally Invasive Surgical Systems Market Report by BIS Research projects the...
The purpose of the study is to gain a holistic view of the strategic outline of regulatory and reimbursement scenario..
What are the standard regulations for robot-assisted surgery devices in the U.S. and international regions?
As of 2018, more than 6,200 surgical robots have been installed across the globe.
1.1 Criteria for Exclusions
2.1 Key Questions to be Answered
3.1 Criteria for Selection of Countries
3.2 Data Sources
4.1 Entry of Surgical Robots in the Market
5.1.1 Regulatory Scenario in U.S.
220.127.116.11 Food and Drug Administration (FDA) and Classification of Medical Devices
18.104.22.168 Groups Ensuring Regulations and Safety of Surgical Robots
22.214.171.124 Training requirements in the U.S for Performing Robot- Assisted Surgeries (RAS)
5.1.2 Reimbursement Scenario in the U.S.
126.96.36.199 Coverage for Use of Robotic Technique Within the Policies of Major Private Health Insurance Providers in the U.S.
5.2.1 Regulatory Scenario in Canada
5.2.2 Reimbursement Scenario in Canada
188.8.131.52 Key Stakeholders in the Canadian Reimbursement Process
184.108.40.206 Reimbursement for Medical
6.1.1 Regulatory Scenario in Japan
220.127.116.11 Regulatory Pathway for Medical
18.104.22.168 Structure of Healthcare System in Japan
6.1.2 Reimbursement Scenario in Japan
22.214.171.124 Reimbursment of daVinci Surgical Robotic Systems in Japan
6.2.1 Regulatory Scenario in China
126.96.36.199 Classification of Medical Devices in China
188.8.131.52 Regulatory Changes in China
184.108.40.206 The Market Access Process For Imported Medical Devices
6.2.2 Reimbursement Scenario in China
220.127.116.11 Provincial Reimbursement Issues
6.3.1 Regulatory Scenario in Australia
18.104.22.168 Lifecycle of Regulations by TGA
22.214.171.124 Post-market Regulations
126.96.36.199 Adverse Event and Incident Reporting
6.3.2 Reimbursement Scenario in Australia
7.1 Regulatory Scenario in European Union
7.1.1 Changes in Rule
7.1.2 New Rules in the Annexure VIII
188.8.131.52 Expanded Device Definitions Requiring Reexamination of Current Classification of all Devices
184.108.40.206 Quality Management System
220.127.116.11 Technical File
18.104.22.168 Need to Comply with New Identification and Traceability (UDI) Requirements
22.214.171.124 More Emphasis on Post Market Surveillance
126.96.36.199 Role of Internal Audits and Requirement of Audits Strengthened
188.8.131.52 Dedicated Personal for MDR
7.2 Reimbursement Scenario in European Union
184.108.40.206 Multiple Technology Appraisal
220.127.116.11 Single Technology Appraisal (STA)
Table 6.1 The TGA Medical Device Classification System
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