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Global Medical Equipment Industry Regulatory Outlook: Top 12 Countries

Product Type: Market Research Report
Published by: Global Markets Direct
Published: December 2008
Product Code: R3480-7702
Description
Global Medical Equipment Industry Regulatory Outlook: Top 12 Countries

Summary

The biggest hurdle being faced by the healthcare industry today is the ever-expanding regulatory pressure. The un-uniformity in the regulatory systems across geographies very often gives strategic advantages to specific companies - a reason that justifies the huge geographical expansions that most of the leading players have undertakenGlobal Markets Direct’s “Global Medical Equipment Industry Regulatory Outlook: Top 12 countries” is an essential source of information on the medical equipment regulatory structure in the leading economies of the world. The report provides in-depth insight on the prevailing regulatory landscape, expected changes in the systems and procedures and their likely impact on the overall industry structure and function. The report identifies the strengths and weaknesses in the regulatory structure of all the 12 countries being studied.

Scope
  • The report covers medical equipment industry regulatory outlook in the leading geographies of the world namely the United States, Canada, UK, Germany, France, Italy, Spain, Japan, China, India, Australia, and Brazil.
  • Annualized overall medical equipment market revenues data from 2000 to 2007, forecast forward for 5 years to 2012.
  • The report provides in-depth coverage of the prevailing regulatory systems and procedures in the top 12 countries.
  • Key topics covered include the recent developments in the medical equipment regulatory procedures and the associated stakeholders’ perspectives.
  • The report also covers reforms and policy amendments that are set to impact the shape of the medical equipment industry.
  • The report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by Global Markets Direct’s team of industry experts.
Reasons to buy
  • Design your market entry and penetration strategies by understanding the regulatory landscape.
  • Identify regulatory barriers to proactively plan and implement market entry strategies.
  • Identify intricacies in the regulatory systems and take remedial measures to ensure smooth operations in a given country.
  • Effectively plan market positioning strategies in accordance with the prevailing business environment.
Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 What Is This Report About?
3 Executive Summary
4 Medical Equipment Sector Review
4.1 Introduction and Definition
4.2 Market Overview
4.3 Market Size and Share Analysis (2000 - 2012)
4.4 Key Future Trends
4.5 Drivers and Restraints Analysis
4.6 Market Drivers
4.7 Market Restraints
5 Medical Equipment Industry in Australia
5.1 Definition
5.2 Overview of the Medical Equipment Industry
5.3 Domestic Performance of the Medical Equipment Sector
5.4 Ageing Population Driving Healthcare Expenditure
5.5 Regulation System in Australia
5.6 Medical Equipment Approval Process
5.7 Advertising
5.8 Labeling and Packaging
5.9 Post-market Surveillance
5.10 Registration Fee
5.11 Pricing and Reimbursement
5.12 Distribution Structure
6 Medical Equipment Industry In India
6.1 Definition
6.2 Overview of the Medical Equipment Industry
6.3 Domestic Performance of the Medical Equipment Sector
6.4 Impact of Demographics
6.5 Regulation System in India
6.6 Classification of Medical Devices
6.7 Registration Period
6.8 Import of Medical Devices
6.9 Post-market Surveillance
6.10 Labeling
6.11 Pricing and Reimbursement
6.12 Distribution Structure
7 Medical Equipment Industry in Brazil
7.1 Overview of the Medical Equipment Industry
7.2 Domestic Performance of the Medical Equipment Sector
7.3 Impact of Demographics
7.4 Regulation System in Brazil
7.5 Medical Device Registration Protocol
7.6 Labeling
7.7 Pricing and Reimbursement
7.8 Distribution Structure
8 Medical Equipment Industry in Canada
8.1 Definition
8.2 Overview of the Medical Equipment Industry
8.3 Domestic Performance of the Medical Equipment Sector
8.4 Impact of Demographics
8.5 Regulation System in Canada
8.6 Medical Equipment Approval Process
8.7 Labeling and Packaging
8.8 Post-Market Surveillance
8.9 Pricing and Reimbursement
8.10 Distribution Structure
9 Medical Equipment Industry in China
9.1 Definition
9.2 Overview of the Medical Equipment Industry
9.3 Domestic Performance of the Medical Equipment Sector
9.4 Impact of Demographics
9.5 Regulation System in China
9.6 Medical Equipment Approval Process
9.7 Labeling and Packaging
9.8 Registration Fee
9.9 Post Market Surveillance (PMS)
9.10 Pricing and Reimbursement
9.11 Distribution Structure
10 Medical Equipment Industry in France
10.1 Definition
10.2 Overview of the Medical Equipment Industry
10.3 Domestic Performance of the Medical Equipment Sector
10.4 Impact of Demographics
10.5 Regulation System in France
10.6 Medical Equipment Approval Process
10.7 Registration Fee
10.8 Post Market Surveillance (PMS)
10.9 Pricing and Reimbursement Policies
10.10 Distribution Structure
11 Medical Equipment Industry in Japan
11.1 Definition
11.2 Overview of the Medical Equipment Industry
11.3 Domestic Performance of the Medical Equipment Sector
11.4 Impact of Demographics
11.5 Regulation System in Japan
11.6 Medical Equipment Approval Process
11.7 Post Marketing Surveillance
11.8 Labeling and Packaging
11.9 Pricing and Reimbursement
11.10 Distribution Structure
12 Medical Equipment Industry in Spain
12.1 Definition
12.2 Overview of the Medical Equipment Industry
12.3 Domestic Performance of the Medical Equipment Sector
12.4 Impact of Demographics
12.5 Regulation System in Spain
12.6 Medical Equipment Approval Process
12.7 Post Market Surveillance (PMS)
12.8 Pricing and Reimbursement
12.9 Distribution Structure
13 Medical Equipment Industry in United Kingdom
13.1 Definition
13.2 Overview of the Medical Equipment Industry
13.3 Domestic Performance of the Medical Equipment Sector
13.4 Impact of Demographics
13.5 Regulation System in UK
13.6 Medical Equipment Approval Process
13.7 Medical Device Approval Fee
13.8 Post Market Surveillance (PMS)
13.9 Pricing and Reimbursement
13.10 Distribution Structure
14 Medical Equipment Industry in USA
14.1 Definition
14.2 Overview of the Medical Equipment Industry
14.3 Domestic Performance of the Medical Equipment Sector
14.4 Impact of Demographics
14.5 Regulation System in USA
14.6 Pricing and Reimbursement
14.7 Distribution Structure
15 Medical Equipment Industry in Germany
15.1 Definition
15.2 Overview of the Medical Equipment Industry in Germany
15.3 Domestic Performance of Medical Equipment Industry in Germany
15.4 Regulation System in Germany
15.5 Medical Equipment Approval Process
15.6 Conformity Assessment Process
15.7 Post Market Surveillance
15.8 Pricing and Reimbursement
15.9 Distribution Structure
16 Medical Equipment Industry in Italy
16.1 Definition
16.2 Overview of the Medical Equipment Industry
16.3 Domestic Performance of the Medical Equipment Sector
16.4 Impact of Demographics
16.5 Regulation System in Italy
16.6 Medical Equipment Approval Process
16.7 Classificazione Nazionale Dispositivi (CND) - New Medical Device Classification
16.8 Post Market Surveillance
16.9 Pricing and Reimbursement
16.10 Distribution Structure
17 Appendix
17.1 Research Methodology
17.2 Coverage
17.3 Secondary Research
17.4 Primary Research
17.5 Models
17.6 Forecasts
17.7 Expert Panels
17.8 Global Markets Direct Consulting
17.9 Contact Us
17.10 Disclaimer
1.1 List of Tables
Table 1: Overall Revenues ($ mn) in the Global Medical Equipment Market (2000-2012)
Table 2: Company Share in the Global Medical Equipment Market ($ m), 2006 - 2007
Table 3: Conformity Assessment of Medical Devices based Device Class, in Australia, 2008
Table 6: Types of Medical Devices That Require Conformity Assessment Certificate From The TGA, 2008
Table 4: Fee for Registered Device in Australia, 2008
Table 5: Fee for Device Clinical Trial in Australia, 2008
Table 6: Evaluation Fee for High and Low Level Registration of Medical Device in Australia, 2008
Table 7: Evaluation Fee for Variation Registration of Medical Device in Australia, 2008
Table 8: Fee for Registration of Listed Devices in Australia, 2008
Table 9: Fee for Registration of Listed Devices for Export Only in Australia, 2008
Table 10: Fee for Registration of Included Devices in Australia, 2008
Table 11: Fee for Initial Conformity Assessment of Medical Device in Australia, 2008
Table 12: Fee for Medical Device Changes Conformity Assessment in Australia, 2008
Table 13: Fee for Medical Device Conformity Assessment Surveillance Audit in Australia, 2008
Table 14: Fee for Medical Device Conformity Assessment Review Certificate in Australia, 2008
Table 15: Fee for Initial Conformity Assessment of Medical Device Components in Australia, 2008
Table 16: Fee for Conformity Assessment of Changes in Medical Device Components in Australia, 2008
Table 17: Fee for Abridged Conformity Assessment of Medical Device Components in Australia, 2008
Table 18: Fee for Inclusion of Medical Device in the Register in Australia, 2008
Table 19: Fee for ARTG Inclusion for Medical Device in Australia, 2008
Table 20: Medical Device Registration Fee in Brazil, 2002
Table 21: Medical Equipment Classification in Canada, 2008
Table 22: Medical Equipment Licensing Fee and Processing Duration in Canada, 2008
Table 23: Registration fee and validity of certificates for IVD reagents, 2008
Table 24: Registration Processing Time for Medical Devices in Japan, 2008
Table 25: Product Registration Fee for Medical Devices in Japan, 2008
Table 26: Medical Device Approval Fee in UK, 2008
Table 27: Medical Equipment Registration Fee in United States, 2008
Table 28: Medical Device Approval Time in United States, 2006-2007
Table 29: Agency determining payment in Germany
Table 30: Reimbursement Mechanism for Innovative products
Table 31: Evidence requirements can differ between settings of care
1.2 List of Figures
Figure 1: Overall Revenues ($ mn) in the Global Medical Equipment Market (2000-2012)
Figure 2: Company Share in the Global Medical Equipment Market (%), 2007
Figure 3: Global Medical Equipment Market, Drivers
Figure 3: Aging Population, Global, 2006 - 2050
Figure 5: Global Medical Equipment Market, Restraints
Figure 5: Classification of Medical Devices in Australia, 2008
Figure 6: Classification of Noninvasive Devices in Australia, 2008
Figure 7: Classification of Invasive Devices in Australia, 2008
Figure 8: Classification of Invasive Devices in Australia, 2008
Figure 9: Classification of Active Devices in Australia, 2008
Figure 10: Classification of Special Medical Devices in Australia, 2008
Figure 11: Conformity Assessment Procedure for Medical Devices in Australia, 2008
Figure 12: Proposed Medical Equipment Classification in India, 2005
Figure 13: Medical Equipment Registration Process in China, 2007
Figure 14: CCC Mark Certification Process in China, 2007
Figure 15: Flowchart for Classification of Non-invasive Devices in France, 2008
Figure 16: Flowchart for Classification of Invasive Devices in France, 2008
Figure 17: Flowchart for Classification of Invasive Devices in France, 2008
Figure 18: Flowchart for Classification of Invasive Devices in France, 2008
Figure 19: Flowchart for Classification of Invasive Devices in France, 2008
Figure 20: Flowchart for Classification of Active Devices in France, 2008
Figure 21: Flowchart for Classification of Active Devices in France, 2008
Figure 22: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in France, 2008
Figure 23: Conformity Assessment of Class-I Medical Devices in France, 2008
Figure 24: Conformity Assessment of Class-IIa Medical Devices in France, 2008
Figure 25: Conformity Assessment of Class-IIb Medical Devices in France, 2008
Figure 26: Conformity Assessment of Class-III Medical Devices in France, 2008
Figure 27: Medical Equipment Distribution Structure in France, 2008
Figure 28: Medical Device Classification in Japan, 2008
Figure 29: Approval Process for Controlled Medical Devices in Japan, 2008
Figure 30: Approval Process for Highly Controlled Medical Devices in Japan, 2008
Figure 31: Health Insurance Reimbursement Process in Japan, 2008
Figure 32: Distribution Structure for Medical Equipment in Japan, 2008
Figure 33: Flowchart for Classification of Non-invasive Devices in Spain, 2008
Figure 34: Flowchart for Classification of Invasive Devices in Spain, 2008
Figure 35: Flowchart for Classification of Invasive Devices in Spain, 2008
Figure 36: Flowchart for Classification of Invasive Devices in Spain, 2008
Figure 37: Flowchart for Classification of Invasive Devices in Spain, 2008
Figure 38: Flowchart for Classification of Active Devices in Spain, 2008
Figure 39: Flowchart for Classification of Active Devices in Spain, 2008
Figure 40: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Spain, 2008
Figure 41: Conformity Assessment of Class-I Medical Devices in Spain, 2008
Figure 42: Conformity Assessment of Class-IIa Medical Devices in Spain, 2008
Figure 43: Conformity Assessment of Class-IIb Medical Devices in Spain, 2008
Figure 44: Conformity Assessment of Class-III Medical Devices in Spain, 2008
Figure 45: Flowchart for Classification of Non-invasive Devices in UK, 2008
Figure 46: Flowchart for Classification of Invasive Devices in UK, 2008
Figure 47: Flowchart for Classification of Invasive Devices in UK, 2008
Figure 48: Flowchart for Classification of Invasive Devices in UK, 2008
Figure 49: Flowchart for Classification of Invasive Devices in UK, 2008
Figure 50: Flowchart for Classification of Active Devices in UK, 2008
Figure 51: Flowchart for Classification of Active Devices in UK, 2008
Figure 52: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in UK, 2008
Figure 53: Conformity Assessment of Class-I Medical Devices in UK, 2008
Figure 54: Conformity Assessment of Class-IIa Medical Devices in UK, 2008
Figure 55: Conformity Assessment of Class-IIb Medical Devices in UK, 2008
Figure 56: Conformity Assessment of Class-III Medical Devices in UK, 2008
Figure 57: Medical Equipment Approval Process in the United States, 2008
Figure 58: PMA Approval Process in the United States, 2008
Figure 59: The 510(k) Approval Process for Medical Devices in the United States, 2008
Figure 60: Healthcare Reimbursement Structure in the United States, 2007
Figure 61: Medical Equipment Sector Distribution Structure in the United States, 2007
Figure 8: SWOT Analysis of Medical Equipment Market in Germany, 2008
Figure 62: Flowchart for Classification of Non-invasive Devices in Germany, 2008
Figure 63: Flowchart for Classification of Invasive Devices in Germany, 2008
Figure 64: Flowchart for Classification of Invasive Devices in Germany, 2008
Figure 65: Classification of Invasive Devices in Germany, 2008
Figure 66: Classification of Invasive Devices in Germany, 2008
Figure 67: Flowchart for Classification of Active Devices in Germany, 2008
Figure 68: Flowchart for Classification of Active Devices in Germany, 2008
Figure 69: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Germany, 2008
Figure 70: Conformity Assessment of Class-I Medical Devices in Germany, 2008
Figure 71: Conformity Assessment of Class-IIa Medical Devices in Germany, 2008
Figure 72: Conformity Assessment of Class-IIb Medical Devices in Germany, 2008
Figure 73: Conformity Assessment of Class-III Medical Devices in Germany, 2008
Figure 74: Flowchart for Classification of Non-invasive Devices in Italy, 2008
Figure 75: Flowchart for Classification of Invasive Devices in Italy, 2008
Figure 76: Flowchart for Classification of Invasive Devices in Italy, 2008
Figure 77: Flowchart for Classification of Invasive Devices in Italy, 2008
Figure 78: Flowchart for Classification of Invasive Devices in Italy, 2008
Figure 79: Flowchart for Classification of Active Devices in Italy, 2008
Figure 80: Flowchart for Classification of Active Devices in Italy, 2008
Figure 81: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Italy, 2008
Figure 82: Conformity Assessment of Class-I Medical Devices in Italy, 2008
Figure 83: Conformity Assessment of Class-IIa Medical Devices in Italy, 2007
Figure 84: Conformity Assessment of Class-IIb Medical Devices in Italy, 2008
Figure 85: Conformity Assessment of Class-III Medical Devices in Italy, 2008
Figure 86: Global Markets Direct Methodology
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