Medical and scientific equipment industries
Industry Commission inquiry report
Released 20 / 12 / 1996
This report contains the findings of the inquiry into Australia's medical and scientific equipment industries, including the emerging trends in local and global markets for the industries and the international marketing environment, including tariff and non-tariff barriers to Australian exports, and the effectiveness of Government efforts to improve market access for the industries.
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- Contents
Preliminaries
Cover, Copyright, Signing Page, Contents, Abbreviations, Overview, Recommendations, Findings
1 The inquiry
1.1 Scope of the inquiry
1.2 Commission’s approach
1.3 Conduct of the inquiry
1.4 Sources of information
1.5 Structure of the report
2 Medical equipment: markets and industry structure
2.1 Global market
2.2 Global production
2.3 Global trade
2.4 Australian market
2.5 Australian production
2.6 Summary
3 Scientific equipment: markets and industry structure
3.1 Global market
3.2 Global production
3.3 Global trade
3.4 Australian market
3.5 Australian production
3.6 Summary
4 Regulation of medical devices
4.1 Regulation of medical devices in Australia
4.2 Problems with Australia’s regulatory approach
4.3 Reforms to conformance assessment
4.4 Reform of the regulatory system
4.5 Specific issues related to regulation
5 Government procurement
5.1 Procurement and related arrangements
5.2 Participants’ concerns
5.3 Issues in procurement policy
5.4 Issues in procurement administration
5.5 Other issues related to procurement
5.6 Commission’s assessment
6 Labour market issues
6.1 Education and training
6.2 Industrial relations
6.3 Commission’s assessment
7 Research and development
7.1 Government support for research and development
7.2 Direct measures of assistance
7.3 Indirect measures of government assistance
7.4 National Health and Medical Research Council
7.5 Conclusions
8 Finance, export and management assistance
8.1 Availability and access to finance
8.2 Export and business management assistance
9 Tariffs and related arrangements
9.1 Tariffs on medical and scientific equipment
9.2 Concessional tariff arrangements
9.3 Economic effects of tariffs
9.4 Participants’ comments
9.5 Commission’s assessment
9.6 Anti-dumping
10 Future prospects
10.1 Strengths and weaknesses
10.2 Emerging threats and opportunities
10.3 Concluding comments
C Submissions and participants
C.1 Visits
C.2 Roundtable participants
C.3 Public hearing participants
C.4 Submissions
D Regulation of medical devices in Australia
D.1 Legislation covering medical devices
D.2 Rationale for regulating medical devices
D.3 The approach to medical device regulation
D.4 The national system of controls
D.5 Stages of device regulation
E Implications of the Competition Principles Agreement
E.1 Provisions of the Competition Principles Agreement
E.2 Application of the Agreement to government-provided assessment services
F Medical device regulation in the European Union
F.1 Global harmonisation
F.2 Regulation of medical devices in the European Union
F.3 The Australian Mutual Recognition Agreement on Conformity Assessment with the European Union
G Procurement arrangements for medical and scientific equipment
G.1 New South Wales
G.2 Victoria
G.3 Western Australia
G.4 South Australia
G.5 Tasmania
G.6 Australian Capital Territory
G.7 Commonwealth Government
Attachment 1 Memorandum of Understanding
H Finance, export, business management and international linkage measures
H.1 Sources of finance for medical and scientific equipment manufacturers
H.2 Private finance markets
H.3 Government assistance for export, business management and developing international linkages
I Chapter 90 tariff items
I.1 Customs Tariff, Schedule 3
J Main ANZSIC divisions for medical and scientific equipment industry activities
K Survey questionnaire
L Survey results
References