South Africa – Medical Technology Master Plan: A Pathway to Inclusive Growth and Industrialisation
The “Medical Technology (MEDTECH) Master Plan” is South Africa’s strategic roadmap for fostering a robust, competitive, and inclusive medical technology industry. Spearheaded by the Department of Trade, Industry and Competition (DTIC) and supported by key stakeholders, including industry bodies, labour unions, and research institutions, the plan outlines actionable steps to enhance domestic manufacturing, reduce dependency on imports, and create a sustainable ecosystem for innovation and growth. The overarching vision is to establish South Africa as a global leader in the MEDTECH sector by 2035.
The Current Landscape of MEDTECH in South Africa
South Africa’s MEDTECH industry, encompassing medical devices and in vitro diagnostics (IVDs), is regulated under the Medicines and Related Substances Act 101 of 1965. The sector’s diversity spans low-tech consumables, such as syringes and gauze, to high-tech devices such as MRI machines and robotic surgery systems. Despite its potential, the industry faces challenges, including heavy reliance on imports, limited local manufacturing capacity, and underfunded research and development.
● Market Size and Structure: Valued at R21 billion in 2021, the industry is projected to grow to R29.6 billion by 2025. Local manufacturing contributes between $200 million and $300 million annually, with over half exported. However, 90% of the domestic market relies on imports, creating a trade imbalance.
● Employment: The sector employs between 10,000 and 30,000 individuals, with a significant representation of women. Employment is concentrated in Gauteng and the Western Cape, reflecting regional economic disparities.
● Regulatory Environment: The South African Health Products Regulatory Authority (SAHPRA) classifies medical devices into four risk categories. While local regulations align with global standards, regulatory fragmentation within Africa hinders regional trade.
Vision 2035 and Strategic Objectives
The MEDTECH Master Plan envisions a digitalised, integrated, and cohesive ecosystem that delivers safe, high-quality, and affordable medical technologies. The key strategic objectives include:
1. Industry Growth: Develop a competitive industry focusing on small and medium enterprises (SMEs) to cater to domestic and export markets.
2. Trade Deficit Reduction: Decrease the industry-specific trade deficit by 5% within five years.
3. Job Creation: Generate 1,000 new jobs over three years by fostering technical skills and innovation.
4. Digitalisation: Employ artificial intelligence to streamline regulatory processes.
Pillars of the Master Plan
To achieve its goals, the plan is structured around four key pillars:
1. Regulatory Framework
An enabling regulatory environment is pivotal for the growth of the MEDTECH industry. South Africa aims to harmonise regulatory standards across Africa, reduce costs for manufacturers, and ensure product safety.
● Establish a public-private MEDTECH stakeholder forum to align regulations and address challenges.
● Conduct regulatory impact assessments to evaluate the implications of new regulations.
● Fast-track alignment with regional regulatory frameworks to promote trade within the African Continental Free Trade Area (AfCFTA).
● Investigate standalone legislation for MEDTECH to support growth and innovation.
2. Market Growth
Expanding market access and promoting local manufacturing are central to reducing reliance on imports.
● Identify MEDTECH products suitable for local production, particularly Class A and B devices such as syringes and bandages.
● Develop preferential procurement agreements to prioritise locally manufactured products in public and private sectors.
● Establish an Africa export strategy leveraging AfCFTA to penetrate regional markets.
● Promote “Proudly South African” campaigns to boost domestic market confidence.
3. Skills Development
A skilled workforce is essential for advancing the MEDTECH sector. The plan emphasises both technical and managerial upskilling.
● Conduct an industry-wide skills gap analysis to identify training needs.
● Collaborate with educational institutions to incorporate MEDTECH-specific courses, including artificial intelligence and regulatory sciences.
● Forge international partnerships to align local training with global best practices.
● Increase women’s and historically disadvantaged individuals’ participation in the sector.
4. Research, Innovation, and Data
Investing in research and development (R&D) is critical to fostering innovation and creating a globally competitive industry.
● Establish an innovation platform to connect R&D with manufacturing and market needs.
● Incentivise public and private sector collaboration in MEDTECH R&D.
● Create a centralised data repository to support evidence-based decision-making.
● Develop shared infrastructure for testing and prototyping, leveraging existing facilities such as the Nano Micro-Manufacturing Facility.
Challenges and Opportunities
Challenges:
● High dependence on imports stifles local manufacturing.
● Regulatory misalignments within Africa increase costs and complexity for manufacturers.
● Limited access to venture capital hampers innovation.
● Skills shortages, particularly in high-tech areas such as clinical engineering, constrain growth.
Opportunities:
● The growing demand for affordable healthcare technologies creates a ripe market for local manufacturers.
● Collaboration with regional and international partners can enhance technological capabilities.
● The rise of digital health and artificial intelligence offers avenues for innovation in regulatory and operational processes.
Governance and Implementation: Driving the MEDTECH Vision Forward
The success of South Africa’s “Medical Technology Master Plan” depends on effective governance and well-coordinated implementation efforts across stakeholders. To achieve its ambitious goals, the Master Plan sets forth a robust governance framework centred on collaboration, accountability, and continuous monitoring. This framework not only ensures the alignment of resources and efforts but also provides the flexibility to adapt to the dynamic needs of the industry.
Executive Oversight Committee (EOC): Leading the Charge
At the heart of the governance structure is the **Executive Oversight Committee (EOC)**, a high-level, multi-stakeholder body responsible for providing leadership and ensuring the successful implementation of the Master Plan.
Roles and Responsibilities:
● Strategic Leadership: The EOC will champion the vision and objectives of the Master Plan, ensuring all stakeholders remain focused on its goals.
● Monitoring and Evaluation: It will establish baselines and targets, as well as oversee a comprehensive monitoring and evaluation (M&E) framework to track progress.
● Stakeholder Coordination: The EOC will facilitate collaboration between government departments, industry bodies, research institutions, and labour organisations.
● Decision-Making: Meetings, chaired by the Director-General of the DTIC, will be held biannually to address challenges, assess progress, and guide the work of task teams.
Stakeholder Collaboration: A Social Compact
The governance framework emphasises the importance of creating a social compact, bringing together government, industry, labour, and academia to share responsibility for the Master Plan’s outcomes.
Monitoring and Evaluation Framework
A robust “monitoring and evaluation (M&E) framework” is critical to the governance process. This framework will:
● Establish baseline benchmarks to measure progress.
● Implement KPIs to track goals such as trade deficit reduction, job creation, and regulatory improvements.
● Conduct periodic reviews to assess progress and recalibrate strategies as needed.
Conclusion
The “Medical Technology Master Plan” represents a transformative vision for South Africa’s MEDTECH industry. By addressing regulatory barriers, fostering innovation, and building a skilled workforce, the plan aims to position South Africa as a hub for medical technology in Africa and beyond. Achieving this vision requires unwavering commitment from all stakeholders and sustained investment in local capabilities. As the plan unfolds, it has the potential to enhance healthcare outcomes, drive economic growth, and cement South Africa’s status as a leader in medical innovation.
Aric Jabari is a Fellow, and the Editorial Director at the Sixteenth Council.
