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    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2026

    Pila Rulashe | South Africa | 12 August 2026

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2020

    Stephen Timm | South Africa | 30 November 2020

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2019

    Louise Mitchell | South Africa | 15 May 2019

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2017

    Louise Mitchell | South Africa | 24 May 2017

    Report Info

    Report Summary Table of Contents
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    Report Coverage

    This report examines the manufacture and supply of medical and surgical equipment in South Africa. It analyses the industry value chain, the size and performance of the domestic industry, key trends, challenges and opportunities, trade dynamics, regulatory developments, enterprise development, regional and international markets, and the factors shaping industry competitiveness and growth. The report also profiles 61 notable companies operating in the sector, including Ascendis Health, B. Braun Medical, Fresenius Kabi, Johnson & Johnson Medical, Medtronic Africa, Roche Products, Siemens Healthcare, and Sinapi Biomedical.

    Introduction

    Introduction
    • The South African medical devices industry encompasses the manufacture, importation, distribution and servicing of a wide range of medical and surgical equipment used across the public and private healthcare sectors.
    • According to the US International Trade Administration (ITA), the total value of medical device sales in South Africa rose by 3.7% to R25.5bn in 2025, up from R24.6bn in 2024.
    • The industry is characterised by a strong reliance on imported technologies and devices, complemented by a smaller but growing domestic manufacturing base.
    • The medical technology industry is a key focus of South Africa's industrialisation agenda, with government and industry stakeholders working to strengthen local manufacturing capabilities, increase localisation, and reduce dependence on imported medical products.
    • These objectives are supported by the Medical Technology Master Plan, launched by the Department of Trade, Industry and Competition in 2024.
    • The plan aims to position South Africa as a regional medical technology hub, improve supply chain resilience, and support broader healthcare outcomes by expanding domestic production, attracting investment, enhancing competitiveness, deepening supplier development, and increasing participation in regional and global value chains.

    Trends

    • AI-enabled medical devices are becoming increasingly prevalent across diagnostics, imaging, patient monitoring and surgical applications.
    • Globally, multi-site manufacturing strategies are increasingly common as companies seek to reduce reliance on single-country production hubs.
    • Healthcare and medical device companies are diversifying their supply chains to strengthen resilience to geopolitical and trade-related disruptions.
    • In South Africa, there is a growing focus on localisation initiatives, supported by government efforts to reduce import dependence and strengthen domestic production capabilities.
    • Medical device business models are shifting from capital equipment sales to service-based revenue models centred on usage, outcomes and subscriptions. Pay-per-use pricing models are gaining traction, allowing healthcare providers to pay based on actual device utilisation rather than on upfront capital expenditure.
    • Medical device manufacturers are creating new revenue streams by commercialising anonymised data insights and analytics services.
    • Population ageing, coupled with the rising incidence of non-communicable diseases such as cardiovascular disease, diabetes and cancer, is driving increased demand for medical devices, advanced diagnostics, patient monitoring systems and healthcare services.
    • Software, AI capabilities and cloud-based services are increasingly bundled with medical devices and monetised through subscription fees.
    • South African medical technology regulatory standards are increasingly aligned with international standards.
    • Suppliers are increasingly using proprietary accessories, consumables and reagents to create long-term customer lock-in and recurring revenue.
    • The adoption of Internet of Medical Things (IoMT) technology is enabling predictive maintenance, improving equipment uptime and operational efficiency.
    • The growing adoption of connected medical technologies is elevating cybersecurity as a key priority for regulation, compliance and risk management.

    Opportunities

    • Capturing opportunities arising from regulatory convergence with international standards by developing compliant products that can compete across multiple markets.
    • Developing locally relevant AI solutions and diagnostic algorithms tailored to South Africa’s disease burdens, healthcare challenges and resource constraints.
    • Developing remote monitoring and telehealth-enabled devices to support decentralised care delivery and improve patient access to healthcare services.
    • Expanding AI-enabled products to improve diagnostic accuracy, clinical decision-making and workflow efficiency.
    • Expanding production and distribution networks to strengthen supply chain resilience and reduce exposure to geopolitical and trade-related disruptions.
    • Export growth into other African countries presents opportunities for manufacturers and distributors that can navigate regulatory requirements.
    • Introducing pay-per-use commercial models to improve affordability for public and private healthcare providers.
    • Investing in local manufacturing and assembly capabilities to benefit from localisation initiatives, public procurement preferences and potential incentives.
    • Leveraging aggregated device data to develop new analytics services for healthcare providers, researchers, pharmaceutical companies and insurers.
    • Providing equipment-as-a-service solutions that reduce upfront capital requirements for healthcare providers while improving supplier revenue predictability.
    • Supporting healthcare providers with operational and clinical performance insights to improve outcomes, efficiency and resource utilisation.
    • Targeting growing demand for connected healthcare ecosystems by integrating devices, software platforms, patient records and remote monitoring solutions.

    Challenges

    • An evolving regulatory environment creates uncertainty for manufacturers and distributors.
    • Competition from multinational manufacturers pressures local companies' pricing, market share and profitability.
    • Fiscal pressures on the public sector may reduce procurement volumes and delay investment in new healthcare infrastructure and technologies.
    • Global geopolitical tensions and trade restrictions increase the risk of supply shortages, longer lead times and higher procurement costs.
    • Growing cybersecurity risks associated with connected devices, AI applications and digital health platforms heighten compliance, operational and reputational risks.
    • Healthcare cost-containment measures by both public and private funders may slow the adoption of new technologies and put pressure on pricing structures.
    • Heavy reliance on imported medical devices and components exposes the industry to exchange-rate volatility and global supply-chain disruptions.
    • High regulatory compliance and certification costs, particularly for Class C and D devices, raise operating costs and hinder innovation.
    • Payment delays, particularly for public-sector orders, continue to strain suppliers' cash flow, working capital and business sustainability.
    • Skills shortages in specialised technical, regulatory and digital disciplines may constrain innovation, manufacturing capability and sector growth.
    • Underdeveloped and fragmented regulatory frameworks across many African markets create barriers to regional expansion and complicate market entry.
    • Underfunding of research and development (R&D) limits innovation, product development and the industry's long-term global competitiveness.
    • Weak economic growth and high unemployment are limiting healthcare affordability and constraining private healthcare spending and government healthcare budgets.

    Outlook

    • Despite a projected decline in 2026 sales, the South African medical devices industry is expected to remain resilient over the medium term. Growth prospects are supported by rising healthcare needs associated with an ageing population and a growing burden of chronic diseases, as well as policy initiatives aimed at expanding local manufacturing capacity and reducing import dependence.
    • Demand is likely to be strongest in diagnostics, imaging, patient monitoring, minimally invasive procedures, digital health and AI-enabled solutions.
    • The growing adoption of digital health, remote monitoring and Internet of Medical Things (IoMT)-enabled devices is creating opportunities for more efficient, service-based healthcare delivery models, while advances in artificial intelligence are enhancing diagnostic accuracy, clinical decision-making and operational efficiency across the healthcare system.
    • Government support for localisation and domestic manufacturing may further stimulate local production, reduce reliance on imports and strengthen supply chain resilience.
    • The industry's growth prospects may be moderated by low economic growth, fiscal constraints and high unemployment, which are limiting healthcare affordability and constraining public healthcare expenditure.
    • Although the implementation of National Health Insurance (NHI) could expand access to healthcare services and increase utilisation of medical devices, centralised NHI procurement mechanisms could put pressure on supplier margins, particularly for smaller industry participants.
    • Companies that successfully leverage AI, digital health technologies, recurring-revenue business models and localisation opportunities, while effectively managing regulatory, cybersecurity and economic risks, are likely to be best positioned for growth.

    Read More..
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2026

    Full Report

    R 20 000.00(ZAR) estimated $1250.56 (USD)*

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    Industry Landscape

    R 14 000.00(ZAR) estimated $ 875.39 (USD)*

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    Historical Reports

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2020-11-30

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2019-05-15

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2017-05-24

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    Table of Contents

    [ Close ]
    PAGE
    1. INTRODUCTION 1
    2. DESCRIPTION OF THE INDUSTRY 1
    2.1. Industry Value Chain 3
    2.2. Geographic Position 5
    2.3. Size of the Industry 6
    3. LOCAL 14
    3.1. State of the Industry 14
    3.2. Key Trends 17
    3.3. Key Issues 18
    3.4. Notable Players 21
    3.5. Trade 26
    3.6. Corporate Actions 29
    3.7. Regulations 29
    3.8. Enterprise Development and Social Development 32
    4. AFRICA 33
    5. INTERNATIONAL 39
    6. INFLUENCING FACTORS 44
    6.1. Unforeseen Events 44
    6.2. Economic Environment 45
    6.3. Labour 47
    6.4. Environmental Issues 49
    6.5. Technology, R&D, Innovation 50
    6.6. Government Support 52
    6.7. Input Costs 53
    7. COMPETITIVE ENVIRONMENT 54
    7.1. Competition 54
    7.2. Ownership Structure of the Industry 56
    7.3. Barriers to Entry 57
    8. INDUSTRY SUMMARY 60
    9. OUTLOOK 62
    10. INDUSTRY ASSOCIATIONS 63
    11. REFERENCES 64
    11.1. Publications 64
    11.2. Websites 65
    ANNEXURE 1 – Industry Legislation 66
    ANNEXURE 2 – Harmonised System (HS) Codes 71
    APPENDIX 1 – Summary of Notable Players 72
    COMPANY PROFILES 83
    A P S TERAPIE SUID-AFRIKA CC 83
    ACINO HEALTHCARE GROUP (PTY) LTD 84
    ASCENDIS HEALTH LTD 86
    B BRAUN MEDICAL (PTY) LTD 91
    BAXTER HEALTHCARE SOUTH AFRICA (PTY) LTD 94
    BECTON DICKINSON (PTY) LTD 96
    BRITTAN HEALTHCARE (PTY) LTD 98
    BSN MEDICAL (PTY) LTD 100
    CAPRICORN BIOMEDICAL (PTY) LTD 102
    CE MOBILITY WHEELCHAIRS (PTY) LTD 104
    CHAMPION HEALTH CARE (PTY) LTD 106
    CONSULENS MEDICAL HEALTHCARE SOLUTIONS (PTY) LTD 108
    DEMANT SOUTH AFRICA (PTY) LTD 110
    DIS-CHEM PHARMACIES LTD 112
    DRAGER SOUTH AFRICA (PTY) LTD 126
    ELECTRO SPYRES MEDICAL (PTY) LTD 128
    ELITE SURGICAL SUPPLIES (PTY) LTD 130
    EVERGREEN LATEX CC 132
    FORTIS X (PTY) LTD 134
    FRESENIUS KABI MANUFACTURING SA (PTY) LTD 135
    FRESENIUS KABI SOUTH AFRICA (PTY) LTD 137
    FRESENIUS MEDICAL CARE SOUTH AFRICA (PTY) LTD 140
    GABLER MEDICAL (PTY) LTD 142
    GE HEALTHCARE (PTY) LTD 144
    GROBIR MEDICAL SUPPLIERS (PTY) LTD 146
    HUTZ HOSPI TEC (PTY) LTD 148
    IDT DIAGNOSTICS CC 150
    IMVULA HEALTHCARE LOGISTICS (PTY) LTD 152
    JOHNSON AND JOHNSON MEDICAL (PTY) LTD 154
    LODOX SYSTEMS (PTY) LTD 156
    M AND L MEDICAL SUPPLIERS CC 158
    MEDI-SAFE SURGICALS (PTY) LTD 159
    MEDICAL DIAGNOSTECH (PTY) LTD 161
    MEDICAL INNOVATIONS (PTY) LTD 163
    MEDINOX (PTY) LTD 165
    MEDLOYD HEALTHCARE (PTY) LTD 167
    MEDTRONIC (AFRICA) (PTY) LTD 169
    MEGROTEX (PTY) LTD 171
    MINOAN MEDICAL (PTY) LTD 172
    MOULDPROD EXHIBITIONS LTD 174
    MULTISURGE (PTY) LTD 176
    NEW CLICKS SOUTH AFRICA (PTY) LTD 178
    NTSHATSHELI TRADING (PTY) LTD 182
    ORTHOPAEDIC SUPPLIERS CC 183
    PHILIPS SOUTH AFRICA COMMERCIAL (PTY) LTD 185
    RADICAL MOBILITY (PTY) LTD 187
    ROCHE DIABETES CARE SOUTH AFRICA (PTY) LTD 188
    ROCHE PRODUCTS (PTY) LTD 190
    SA BIOMEDICAL HOLDINGS (PTY) LTD 193
    SAFMED (PTY) LTD 195
    SHONAQUIP (PTY) LTD 197
    SIEMENS HEALTHCARE (PTY) LTD 199
    SINAPI BIOMEDICAL (PTY) LTD 201
    SOUTHERN IMPLANTS (PTY) LTD 203
    SOUTHERN MEDICAL (PTY) LTD 205
    SSEM MTHEMBU MEDICAL (PTY) LTD 207
    STRYKER SOUTH AFRICA (PTY) LTD 209
    TELEFLEX MEDICAL (PTY) LTD 211
    TI-TAMED (PTY) LTD 213
    VERTICE HEALTHCARE (PTY) LTD 215
    YMS MEDICAL SUPPLIES (PTY) LTD 217

    Report Coverage

    This report focuses on the supply and manufacture of medical and surgical equipment and orthopaedic appliances, collectively referred to as medical devices. It includes comprehensive information on the state and size of the sector, the effect of coronavirus, statistics on usage of medical technology, the device market by category, trade and many more. There are profiles of 66 companies including APS Therapy, which imports micro-current pain therapy devices, CE Mobility, which provides locally-manufactured electric wheel chairs and Megrotex, which provides locally-manufactured bandages and dressings.

    Introduction

    This report focuses on the supply and manufacture of medical and surgical equipment and orthopaedic appliances, collectively referred to as medical devices. The sector has over 500 suppliers, many of which are small businesses that are distributors and agents for large multinational subsidiaries. The industry is fragmented with commodities ranging from nuclear cameras and catheters to latex gloves. It is estimated that the value of the South African market was US$1.32bn (about R22.01bn) in revenue in 2019. Before the onset of the coronavirus pandemic the market was forecast to grow to US$1.47bn in 2020. Local production is estimated to have grown by 3.5% to US$119.1m, from 2018 to 2019. Prior to the onset of the pandemic, local production was expected to grow by 10.9% to US$132.1m in 2020. The coronavirus pandemic and subsequent declaration of a state of emergency in March 2020 has created opportunities and challenges for the sector. While it has led to the collapse of elective medical procedures, which has caused sales to dive, it has also created opportunities for companies making ventilators and testing kits.

    Strengths

    • A weakening rand could be a positive driver for the local development and manufacture of medical devices.
    • Licensing requirements will increase compliance for manufacturers as well as product safety.
    • Steady demand for medical devices, even during an economic downturn.

    Weaknesses

    • Medical aid schemes approve payment for the use of medical devices, putting a burden on manufacturers to prove the cost-effectiveness of the use of the device.
    • Registration of locally-developed products in overseas markets is expensive and adds to costs.
    • The medical device research industry is underfunded, limiting the amount of research, innovation and manufacture of medical devices in South Africa.
    • The small size of the domestic market and the fact that only about 10% of the devices used are manufactured locally.

    Opportunities

    • A large poor and under-served population that has difficulty accessing specialists, presents opportunities for innovation.
    • South Africa’s aging population is expected to drive the demand for devices that treat chronic ailments.
    • The use of wearable tech and other digital solutions presents an opportunity for local innovators.

    Threats

    • Increasing number of imports, as well as cheap imports of inferior quality.
    • Increasingly burdensome regulatory landscape is increasing costs of local players.
    • Inefficient public procurement and payment systems place small companies under pressure.
    • The coronavirus pandemic has led to delays in elective surgeries and created other challenges for sector players.
    • The cost of certification is a burden and is a requirement for local manufacturing and exporting.
    • The medical devices market is extremely vulnerable to exchange rate volatility as most devices are imported.

    Outlook

    The coronavirus pandemic and declaration of a state of emergency has created both opportunities and challenges for the sector. While it has led to the collapse of elective medical procedures which has caused sales to dive, it has also created opportunities for companies making ventilators and testing kits. The country’s aging population will likely drive demand for medical devices in year ahead. Industry participants however are concerned about the low level of local production of medical devices. They also remain sceptical about National Health Insurance which is expected to be phased in from 2025.

    Read More..
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2020

    Full Report

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    Buy Now +

    Industry Landscape

    R 1 330.00(ZAR) estimated $ 83.16 (USD)*

    Buy Now +

    Historical Reports

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2026-08-12

    R 20 000.00(ZAR) estimated $1250.56 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2019-05-15

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2017-05-24

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    Table of Contents

    [ Close ]
    PAGE
    1. INTRODUCTION 1
    2. DESCRIPTION OF THE INDUSTRY 1
    2.1. Industry Value Chain 5
    2.2. Geographic Position 6
    3. SIZE OF THE INDUSTRY 6
    4. STATE OF THE INDUSTRY 10
    4.1. Local 10
    4.1.1. Trade 16
    4.1.2. Corporate Actions 18
    4.1.3. Regulations 18
    4.1.4. Enterprise Development and Social Economic Development 21
    4.2. Continental 23
    4.3. International 24
    5. INFLUENCING FACTORS 26
    5.1. Economic Environment 26
    5.2. Government Initiatives 27
    5.3. Intellectual Property 28
    5.4. Western Cape Medical Devices Sector 29
    5.5. Quality Standards 30
    5.6. National Health Insurance (NHI) 30
    5.7. Information Technology (IT), Research and Development and Innovation 31
    5.8. Labour 34
    5.9. Environmental Concerns 36
    6. COMPETITION 37
    6.1. Barriers to Entry 38
    7. SWOT ANALYSIS 39
    8. OUTLOOK 40
    9. INDUSTRY ASSOCIATIONS 40
    10. REFERENCES 41
    10.1. Publications 41
    10.2. Websites 42
    APPENDIX 1 44
    Summary of Notable Players 44
    COMPANY PROFILES 51
    A P S TERAPIE SUID-AFRIKA CC 51
    ACINO HEALTHCARE GROUP (PTY) LTD 52
    ALLYUNG (PTY) LTD 55
    ASCENDIS HEALTH LTD 57
    B BRAUN MEDICAL (PTY) LTD 63
    BAXTER HEALTHCARE SOUTH AFRICA (PTY) LTD 66
    BECTON DICKINSON (PTY) LTD 68
    BRITTAN HEALTHCARE (PTY) LTD 70
    BSN MEDICAL (PTY) LTD 72
    CAPERAY MEDICAL (PTY) LTD 74
    CAPRICORN BIOMEDICAL (PTY) LTD 76
    CE MOBILITY WHEELCHAIRS (PTY) LTD 78
    CERDAK (PTY) LTD 80
    CHAMPION HEALTH CARE (PTY) LTD 82
    CONSULENS MEDICAL HEALTHCARE SOLUTIONS (PTY) LTD 84
    DEMANT SOUTH AFRICA (PTY) LTD 86
    DIS-CHEM PHARMACIES LTD 88
    DRAGER SOUTH AFRICA (PTY) LTD 98
    ELECTRO SPYRES MEDICAL (PTY) LTD 100
    ELITE SURGICAL SUPPLIES (PTY) LTD 102
    EVERGREEN LATEX CC 104
    FLUORO VIZION (PTY) LTD 106
    FORTIS X (PTY) LTD 108
    FRESENIUS KABI MANUFACTURING SA (PTY) LTD 109
    FRESENIUS KABI SOUTH AFRICA (PTY) LTD 111
    FRESENIUS MEDICAL CARE SOUTH AFRICA (PTY) LTD 114
    G AND S MEDICAL SUPPLIES CC 116
    GABLER MEDICAL (PTY) LTD 118
    GE HEALTHCARE (PTY) LTD 120
    GROBIR MEDICAL SUPPLIERS (PTY) LTD 122
    HUTZ HOSPI TEC (PTY) LTD 124
    IDT DIAGNOSTICS CC 126
    IMVULA HEALTHCARE LOGISTICS (PTY) LTD 128
    JOHNSON AND JOHNSON MEDICAL (PTY) LTD 130
    LODOX SYSTEMS (PTY) LTD 132
    M AND L MEDICAL SUPPLIERS CC 134
    MEDI-SAFE SURGICALS (PTY) LTD 135
    MEDICAL DIAGNOSTECH (PTY) LTD 137
    MEDICAL INNOVATIONS (PTY) LTD 139
    MEDINOX (PTY) LTD 141
    MEDTRONIC (AFRICA) (PTY) LTD 143
    MEGROTEX (PTY) LTD 145
    MINOAN MEDICAL (PTY) LTD 146
    MOULDPROD EXHIBITIONS LTD 148
    MULTISURGE (PTY) LTD 150
    NEW CLICKS SOUTH AFRICA (PTY) LTD 152
    NTSHATSHELI TRADING (PTY) LTD 155
    ORTHOPAEDIC SUPPLIERS CC 157
    PHILIPS SOUTH AFRICA COMMERCIAL (PTY) LTD 159
    RADICAL MOBILITY (PTY) LTD 161
    RESPITEK (PTY) LTD 162
    ROCHE DIABETES CARE SOUTH AFRICA (PTY) LTD 164
    ROCHE PRODUCTS (PTY) LTD 165
    S A BIOMEDICAL (PTY) LTD 168
    SAFMED (PTY) LTD 170
    SHONAQUIP (PTY) LTD 172
    SIEMENS (PTY) LTD 173
    SINAPI BIOMEDICAL (PTY) LTD 177
    SOUTHERN IMPLANTS (PTY) LTD 179
    SOUTHERN MEDICAL (PTY) LTD 181
    SSEM MTHEMBU MEDICAL (PTY) LTD 183
    STRYKER SOUTH AFRICA (PTY) LTD 185
    TELEFLEX MEDICAL (PTY) LTD 187
    TI-TAMED (PTY) LTD 189
    VOICEAMP (PTY) LTD 191
    WELCH ALLYN SOUTH AFRICA (PTY) LTD 193

    Report Coverage

    This report focuses on the supply and manufacture of medical devices which include medical and surgical equipment and orthopaedic appliances. There are comprehensive profiles of 60 companies. These include local manufacturers such as Hutz, which makes bedhead service systems, theatre control panels and medical and surgical lighting, CapeRay, which makes advanced breast imaging technology, and Lodox, which makes x-ray machines that are used internationally. The report includes information on the state of the industry and the factors that influence it, numerous government initiatives to increase investment in the industry as well as research and development, and the resulting new devices and trends.

    Introduction

    This report focuses on the supply and manufacture of medical and surgical equipment and orthopaedic appliances, collectively referred to as medical devices. In this diverse sector there are more than 600 suppliers, many of which are small businesses that are distributors and agents for large multinational subsidiaries. The industry is fragmented with commodities ranging from nuclear cameras and catheters to latex gloves. It is estimated that the value of the South African market was US$1.56bn (approximately R20.9bn) in 2018 and it is expected to grow by 7.7% to US$1.68bn in 2019. Local manufacture grew by 9.1% to US$211m from 2017 to 2018, to account for about 13.5% of the total value. Local manufacture is expected to grow by 8% to US$227.8m in 2019. Industry players estimate that fewer than 5% of local industry players manufacture devices. The industry is extremely sensitive to currency volatility since more than 76% of devices are imported. The Medicines and Related Substances Amendment Act 14 of 2015 is regarded as a positive development in the regulation of medical devices in South Africa.

    Strengths

    • A weakening rand could be a positive driver for the local development and manufacture of medical devices.
    • Funding is available from the DTI to support local exporters.
    • Increased government spending on equipment as part of the introduction of National Health Insurance.
    • Licensing requirements will increase compliance for manufacturers as well as product safety.
    • Manufacturers in the Western Cape have strong support from local government which promotes innovation and exports.
    • Manufacturers of medical devices are eligible for funding from the Industrial Development Corporation.
    • Recent private equity investment in the sector.
    • Steady demand for medical devices, even during an economic downturn.

    Weaknesses

    • Medical aid schemes approve payment for the use of medical devices, putting a burden on manufacturers to prove the cost-effectiveness of the use of the device.
    • Registration of locally developed products in overseas markets is expensive and adds to costs.
    • The medical device research industry is underfunded, limiting the amount of research, innovation and manufacture of medical devices in South Africa.
    • The small size of the domestic market and the fact that only approximately 5% of the devices used are manufactured locally.

    Opportunities

    • Alternative clinical therapies are presenting untapped sources of innovation.
    • Low socio-economic environments, where under-served populations have difficulties accessing specialists, present opportunities for innovation.
    • The aesthetic medical device market is expected to grow.

    Threats

    • Increasing number of imports, as well as cheap imports of inferior quality.
    • Increasingly burdensome regulatory landscape is increasing costs of local players.
    • Inefficient public procurement and payment systems place smaller companies under pressure.
    • The cost of certification is a burden and is a requirement for local manufacturing and exporting.
    • The medical devices market is extremely vulnerable to exchange rate volatility as most devices are imported.

    Outlook

    Industry participants expect local demand to be boosted by increased health problems and growth in African markets. Regulations that require role players to be licenced are expected to promote fair competition and contribute towards ensuring safe, high quality products for consumers. Commentators pointed out that lengthy registration processes under regulations could adversely affect the saleability of medical devices with short life cycles. Among disruptive forces that are expected to shape the future global medical device industry are heightened regulatory scrutiny, new healthcare delivery models and a shift in buying power from doctors to end-users as a result of evidence-based healthcare.

    Read More..
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2019

    Full Report

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    Buy Now +

    Industry Landscape

    R 1 330.00(ZAR) estimated $ 83.16 (USD)*

    Buy Now +

    Historical Reports

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2026-08-12

    R 20 000.00(ZAR) estimated $1250.56 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2020-11-30

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa 2017-05-24

    R 1 900.00(ZAR) estimated $118.80 (USD)*

    View Report Add to Cart

    Table of Contents

    [ Close ]
    PAGE
    1. INTRODUCTION 1
    2. DESCRIPTION OF THE INDUSTRY 1
    2.1. Industry Value Chain 4
    2.2. Geographic Position 5
    3. SIZE OF THE INDUSTRY 5
    4. STATE OF THE INDUSTRY 9
    4.1. Local 9
    4.1.1. Trade 10
    4.1.2. Corporate Actions 11
    4.1.3. Regulations 12
    4.1.4. Enterprise Development and Social Economic Development 15
    4.2. Continental 17
    4.3. International 18
    5. INFLUENCING FACTORS 20
    5.1. Economic Environment 20
    5.2. Government Initiatives 21
    5.3. Intellectual Property 22
    5.4. Western Cape Medical Devices Sector 23
    5.5. Quality Standards 24
    5.6. National Health Insurance (NHI) 25
    5.7. Information Technology (IT), Research and Development and Innovation 25
    5.8. Labour 27
    5.9. Environmental Concerns 30
    6. COMPETITION 31
    6.1. Barriers to Entry 31
    7. SWOT ANALYSIS 32
    8. OUTLOOK 33
    9. INDUSTRY ASSOCIATIONS 33
    10. REFERENCES 34
    10.1. Publications 34
    10.2. Websites 35
    APPENDIX 1 36
    Summary of Notable Players 36
    COMPANY PROFILES 43
    ACINO HEALTHCARE GROUP (PTY) LTD 43
    ALLYUNG CC 46
    ASCENDIS HEALTH LTD 48
    B BRAUN MEDICAL (PTY) LTD 55
    BAXTER HEALTHCARE SOUTH AFRICA (PTY) LTD 58
    BECTON DICKINSON (PTY) LTD 60
    BRITTAN HEALTHCARE (PTY) LTD 62
    BSN MEDICAL (PTY) LTD 63
    CAPERAY MEDICAL (PTY) LTD 65
    CAPRICORN BIOMEDICAL (PTY) LTD 67
    CERDAK (PTY) LTD 68
    CHAMPION HEALTH CARE (PTY) LTD 70
    CONSULENS MEDICAL HEALTHCARE SOLUTIONS (PTY) LTD 72
    DIS-CHEM PHARMACIES LTD 74
    DRAGER SOUTH AFRICA (PTY) LTD 83
    ELECTRO SPYRES MEDICAL (PTY) LTD 85
    ELITE SURGICAL SUPPLIES (PTY) LTD 87
    EVERGREEN LATEX CC 89
    FLUORO VIZION (PTY) LTD 91
    FORTIS X (PTY) LTD 93
    FRESENIUS KABI MANUFACTURING SA (PTY) LTD 94
    FRESENIUS KABI SOUTH AFRICA (PTY) LTD 96
    FRESENIUS MEDICAL CARE SOUTH AFRICA (PTY) LTD 99
    G AND S MEDICAL SUPPLIES CC 101
    GABLER MEDICAL (PTY) LTD 103
    GE HEALTHCARE (PTY) LTD 105
    GROBIR MEDICAL SUPPLIERS (PTY) LTD 107
    HUTZ HOSPI TEC (PTY) LTD 109
    IDT DIAGNOSTICS CC 111
    IMVULA HEALTHCARE LOGISTICS (PTY) LTD 113
    INFANTRUST PARENTING SOLUTIONS (PTY) LTD 116
    JOHNSON AND JOHNSON MEDICAL (PTY) LTD 118
    LODOX SYSTEMS (PTY) LTD 120
    MEDICAL INNOVATIONS (PTY) LTD 122
    MEDINOX (PTY) LTD 124
    MEDTRONIC (AFRICA) (PTY) LTD 125
    MINOAN MEDICAL (PTY) LTD 127
    MOULDPROD EXHIBITIONS LTD 129
    MULTISURGE (PTY) LTD 131
    NEW CLICKS SOUTH AFRICA (PTY) LTD 132
    ORTHOPAEDIC SUPPLIERS CC 135
    OTICON SOUTH AFRICA (PTY) LTD 137
    PHILIPS SOUTH AFRICA COMMERCIAL (PTY) LTD 139
    RESPITEK (PTY) LTD 141
    ROCHE DIABETES CARE SOUTH AFRICA (PTY) LTD 143
    ROCHE PRODUCTS (PTY) LTD 144
    S A BIOMEDICAL (PTY) LTD 147
    SAFMED (PTY) LTD 149
    SIEMENS (PTY) LTD 151
    SINAPI BIOMEDICAL (PTY) LTD 155
    SOUTHERN IMPLANTS (PTY) LTD 157
    SOUTHERN MEDICAL (PTY) LTD 159
    SPECMED MEDICAL SERVICES (PTY) LTD 161
    SSEM MTHEMBU MEDICAL (PTY) LTD 163
    STRYKER SOUTH AFRICA (PTY) LTD 165
    TELEFLEX MEDICAL (PTY) LTD 167
    TI-TAMED (PTY) LTD 169
    VOICEAMP (PTY) LTD 171
    WELCH ALLYN SOUTH AFRICA (PTY) LTD 173
    WONDERMED (PTY) LTD 175

    Report Coverage

    The report on the Supply and Manufacture of Medical and Surgical Equipment and Orthopaedic Appliances describes current conditions, improvements to the weak regulatory environment and factors that influence the success of the sector. The report profiles 53 companies, including multinationals Johnson and Johnson Medical (Pty) Ltd, Medtronic (Africa) (Pty) Ltd and Siemens (Pty) Ltd. Also profiled are South African manufacturers such as Wondermed (Pty) Ltd and Lodox Systems (Pty) Ltd, which designed and manufactured the Lodox Xmplar-dr, a scanner that takes high-speed, full-body x-ray images and was featured in an episode of Grey’s Anatomy.

    Introduction

    This report focuses on the supply and manufacture of medical and surgical equipment and orthopaedic appliances, collectively referred to as medical devices. In this diverse sector there are more than 600 suppliers, many of whom are small businesses that are distributors and agents for large multinational subsidiaries. The industry is fragmented with commodities ranging from nuclear cameras and catheters to latex gloves. Estimates for the value of the South African market range from R11bn in 2013 to between R13.2bn and R21.7bn in 2015, and shrinking to around R12bn in 2017 as a result of the weak Rand. The industry is extremely sensitive to currency volatility since almost 95% of devices are imported. Improvements to the weak regulatory environment were seen with the introduction of new regulations for medical devices under the Medicines and Related Substances Act 1965 (Act No 101 of 1965) in 2016.

    Strengths

    • Steady demand for medical devices, even during an economic downturn.
    • The new MCC licensing requirements will increase compliance for manufacturers as well as product safety.

    Weaknesses

    • Medical aid schemes approve payment for the use of medical devices, putting a burden on manufacturers to prove the cost-effectiveness of the use of the device.
    • Medical device research industry is underfunded, limiting the amount of research, innovation and manufacture of medical devices in South Africa.
    • Registration in overseas markets is expensive and adds to costs.
    • Regulatory overburden on small businesses puts constraints on entrepreneurial ventures.
    • The small size of the domestic market and the fact that only approximately 5% of the devices used are manufactured locally.
    • Weak regulatory framework for medical devices resulting in the import of poor quality medical devices and long registration periods for some medical device classes.

    Opportunities

    • A weakening Rand could be a positive driver for the local development and manufacture of medical devices.
    • Funding is available from the Dti to support local exporters.
    • Increased government spending on equipment as part of the introduction of the NHI revitalisation programme.
    • Low-resource environments, where under-served populations have difficulties in accessing specialists, present opportunities for innovation.
    • Manufacturers of medical devices are eligible for funding from the IDC.
    • New growth areas offering alternative clinical therapies are presenting untapped sources of innovation.
    • The aesthetic medical device market is expected to grow.

    Threats

    • Increasing number of imports, as well as cheap imports of inferior quality.
    • Increasingly burdensome regulatory landscape is putting constraints on product designs and innovation.
    • Inefficient public procurement and payment systems place smaller companies under pressure.
    • The cost of certification is a burden and is a requirement for local manufacturing and exporting.
    • The medical devices market is extremely vulnerable to exchange rate volatility, especially since most devices are imported.

    Outlook

    Industry participants expect local demand to be boosted by increased government spending on equipment as part of the introduction of the NHI revitalisation programme. The resultant specialised services that will be provided to the broader population are consistent with the National Development Plan and the UN Millennium Development Goals. Challenging economic conditions that include the downgrading of South Africa’s credit rating to junk status, however, may constrain growth. Among disruptive forces that are expected to shape the future global medical device industry are heightened regulatory scrutiny, new healthcare delivery models and a shift in buying power from doctors as a result of evidence-based care.

    Read More..
    The Manufacture and Supply of Medical, Surgical and Orthopaedic Equipment in South Africa
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    Table of Contents

    [ Close ]
    PAGE
    1. INTRODUCTION 1
    2. DESCRIPTION OF THE INDUSTRY 1
    2.1. Industry Value Chain 2
    2.2. Geographic Position 3
    3. SIZE OF THE INDUSTRY 3
    4. STATE OF THE INDUSTRY 12
    4.1. Local 12
    4.1.1. Corporate Actions 15
    4.1.2. Regulations 16
    4.1.3. Enterprise Development and Social Economic Development 19
    4.2. Continental 22
    4.3. International 23
    5. INFLUENCING FACTORS 25
    5.1. Economic Environment 25
    5.2. Government Initiatives 25
    5.3. National Health Insurance 26
    5.4. Government Procurement 27
    5.5. Technology, Research and Development (R&D) and Innovation 27
    5.6. Labour 30
    5.7. Environmental Concerns 32
    6. COMPETITION 33
    6.1. Barriers to Entry 34
    7. SWOT ANALYSIS 35
    8. OUTLOOK 36
    9. INDUSTRY ASSOCIATIONS 36
    10. REFERENCES 37
    10.1. Publications 37
    10.2. Websites 38
    APPENDIX 1 39
    Import Codes for Medical Devices 39
    COMPANY PROFILES 40
    ALLYUNG CC 40
    B BRAUN MEDICAL (PTY) LTD 42
    BARFORD JONES ORTHOMED (PTY) LTD 45
    BRITTAN HEALTHCARE GROUP (PTY) LTD 47
    BSN MEDICAL (PTY) LTD 49
    CAPERAY MEDICAL (PTY) LTD 51
    CAPRICORN BIOMEDICAL (PTY) LTD 53
    CERDAK (PTY) LTD 54
    CHAMPION HEALTH CARE (PTY) LTD 56
    DRAGER SOUTH AFRICA (PTY) LTD 57
    ELECTRO SPYRES MEDICAL (PTY) LTD 59
    ELITE SURGICAL SUPPLIES (PTY) LTD 61
    ENGINEERING QUALITY ORTHOPAEDIC SOLUTIONS (PTY) LTD 63
    FRESENIUS KABI SOUTH AFRICA (PTY) LTD 65
    GABLER MEDICAL (PTY) LTD 69
    INFANTRUST PARENTING SOLUTIONS (PTY) LTD 71
    LODOX SYSTEMS (PTY) LTD 73
    MEDICAL INNOVATIONS (PTY) LTD 75
    MINOAN MEDICAL (PTY) LTD 77
    MOULDPROD EXHIBITIONS LTD 79
    OTICON SOUTH AFRICA (PTY) LTD 81
    PHILIPS SOUTH AFRICA COMMERCIAL (PTY) LTD 83
    PRESTA (PTY) LTD 85
    RESPITEK (PTY) LTD 87
    ROCHE PRODUCTS (PTY) LTD 89
    SAFMED (PTY) LTD 92
    SINAPI BIOMEDICAL (PTY) LTD 94
    SOUTHERN IMPLANTS (PTY) LTD 96
    SOUTHERN MEDICAL (PTY) LTD 98
    SSEM MTHEMBU MEDICAL (PTY) LTD 100
    TI-TAMED (PTY) LTD 103
    VOICEAMP (PTY) LTD 105
    WONDERMED (PTY) LTD 107

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