Turkey's Healthcare Transformation

8 minutes read

Turkey's Healthcare Transformation: Understanding the 12th Development Plan and Its Impact on Medical Device Manufacturers

Introduction

Turkey is embarking on a significant transformation of its healthcare sector through strategic government initiatives that will reshape the landscape for medical device manufacturers and pharmaceutical companies. The 12th Development Plan (2024-2028) and the 2025 Presidential Annual Program represent Turkey's ambitious roadmap toward healthcare self-sufficiency, innovation, and digital transformation.

For medical device manufacturers operating in or planning to enter the Turkish market, understanding these strategic priorities is essential for aligning business strategies with national objectives and identifying emerging opportunities.

Strategic Pillars of Turkey's Healthcare Vision

1. Increasing Domestic Production Capacity

One of the cornerstone objectives of Turkey's healthcare strategy is to significantly boost domestic manufacturing capabilities. The government recognizes that reducing reliance on imported medical devices and pharmaceuticals is crucial for both economic sustainability and healthcare security.

Key Initiatives:

  • Investment incentives for local manufacturing facilities
  • Support for technology transfer partnerships
  • Development of specialized manufacturing zones for healthcare products
  • Strengthening the domestic supply chain infrastructure

What This Means for Manufacturers:

Medical device companies that establish local production facilities in Turkey are likely to benefit from government incentives, preferential treatment in public procurement, and easier market access. Foreign manufacturers should consider partnerships with Turkish companies or establishing local manufacturing operations to align with this strategic direction.

2. Reducing Import Dependency

Turkey aims to decrease its dependence on imported healthcare products, particularly in critical categories where supply chain vulnerabilities have been exposed. This strategic shift reflects lessons learned from global supply disruptions and aims to enhance national healthcare security.

Priority Areas:

  • Essential medical devices and diagnostics
  • Critical pharmaceuticals and active pharmaceutical ingredients (APIs)
  • Advanced therapeutic products
  • Biotechnological products

Implications for the Industry:

While this focus on import substitution might seem challenging for foreign manufacturers, it actually creates opportunities for strategic partnerships, local manufacturing collaborations, and technology transfer agreements. Companies that can demonstrate commitment to local value creation will find a receptive regulatory and business environment.

3. Supporting Innovative Technologies

Innovation sits at the heart of Turkey's healthcare transformation strategy. The government is actively promoting the development and adoption of cutting-edge medical technologies, with particular emphasis on areas where Turkey can develop competitive advantages.

Focus Areas:

  • Digital health solutions and telemedicine platforms
  • Artificial intelligence in diagnostics and treatment
  • Advanced medical imaging technologies
  • Biotechnology and regenerative medicine
  • Personalized medicine and genomics

Opportunities for Medical Device Companies:

Manufacturers developing innovative medical technologies should explore Turkey's growing innovation ecosystem, including research and development incentives, collaboration opportunities with Turkish universities and research institutions, and access to a large patient population for clinical studies.

Digitization: The Digital Health Revolution

Healthcare Digitization Initiatives

Digital transformation represents a major pillar of Turkey's healthcare modernization efforts. The 2025 Presidential Annual Program emphasizes accelerating digitization across the healthcare sector, from patient care delivery to regulatory processes.

Key Digital Health Priorities:

  1. Electronic Health Records (EHR) Expansion: Nationwide implementation of integrated EHR systems to improve care coordination and data accessibility.

  2. Telemedicine Infrastructure: Development of robust telemedicine capabilities, particularly for remote and underserved areas.

  3. AI and Data Analytics: Integration of artificial intelligence and big data analytics for improved diagnostics, treatment planning, and healthcare management.

  4. Digital Regulatory Systems: Modernization of regulatory processes, including the Product Tracking System (ÜTS) and electronic application platforms.

Regulatory Implications

The digitization push affects medical device regulation in several ways:

  • Enhanced Product Tracking: The ÜTS system continues to evolve, requiring more detailed product information and real-time tracking capabilities.

  • Digital Submission Processes: Regulatory applications increasingly move to electronic platforms, requiring manufacturers to adapt their documentation and submission procedures.

  • Post-Market Surveillance: Digital systems enable more sophisticated post-market surveillance, requiring manufacturers to establish robust adverse event reporting and device tracking mechanisms.

Action Items for Manufacturers:

  • Ensure your regulatory team is familiar with Turkey's electronic application systems
  • Implement digital systems for product tracking and post-market surveillance
  • Consider developing digital health solutions that complement your device portfolio
  • Explore opportunities in telemedicine and remote patient monitoring

Biotechnological Products: A Strategic Priority

Turkey is making significant investments in biotechnology, recognizing it as a key area for future competitiveness in the global healthcare market. This includes both biopharmaceuticals and advanced medical devices incorporating biological components.

Biotechnology Initiatives

Recent Developments:

  • Law No 7557 (effective July 2025) legalized the production of medicinal products derived from cannabinoids, opening new therapeutic avenues
  • Increased funding for biotechnology research centers
  • Partnerships between universities and industry for biotech innovation
  • Development of specialized biotech manufacturing facilities

Opportunities in Advanced Therapies

The strategic focus on biotechnology creates opportunities for:

  • Cell and gene therapy product developers
  • Advanced wound care and tissue engineering companies
  • Diagnostic device manufacturers using biomarkers
  • Companies developing biologics delivery systems

Regulatory Considerations:

As Turkey develops its biotechnology sector, manufacturers should anticipate:

  • Evolving regulations for advanced therapy medicinal products (ATMPs)
  • New guidelines for clinical evaluation of biotechnology products
  • Enhanced requirements for manufacturing quality systems
  • Potential fast-track pathways for innovative biotech products

Enhanced Healthcare Sustainability

Sustainability represents both an environmental commitment and an economic imperative in Turkey's healthcare strategy. The government is promoting sustainable practices across the healthcare sector, from manufacturing to waste management.

Sustainability Priorities

  1. Environmental Compliance: Stricter environmental standards for healthcare manufacturing facilities
  2. Resource Efficiency: Emphasis on energy-efficient manufacturing and healthcare delivery
  3. Circular Economy: Promotion of reusable medical devices and recycling programs
  4. Sustainable Procurement: Government preference for environmentally sustainable products

What Manufacturers Should Consider:

  • Evaluate your products' environmental footprint and lifecycle impact
  • Develop sustainable packaging solutions
  • Implement green manufacturing practices
  • Document sustainability initiatives in your regulatory submissions
  • Consider developing reusable device options where clinically appropriate

Practical Implications for Medical Device Manufacturers

Short-Term Actions (2025-2026)

  1. Review Your Market Strategy: Assess how your products and business model align with Turkey's strategic priorities.

  2. Explore Partnership Opportunities: Identify potential Turkish partners for manufacturing, distribution, or R&D collaboration.

  3. Prepare for Regulatory Evolution: Stay informed about regulatory changes implementing these strategic priorities.

  4. Invest in Digital Capabilities: Ensure your systems can interface with Turkey's digital health infrastructure.

  5. Document Innovation: Clearly articulate how your products support Turkey's innovation objectives.

Medium-Term Planning (2026-2028)

  1. Consider Local Manufacturing: Evaluate the business case for establishing manufacturing operations in Turkey.

  2. Develop Digital Health Solutions: Explore opportunities to integrate digital capabilities into your product portfolio.

  3. Build R&D Partnerships: Collaborate with Turkish research institutions on innovative product development.

  4. Sustainability Integration: Implement comprehensive sustainability programs aligned with Turkish priorities.

  5. Capacity Building: Invest in training and development for Turkish partners and employees.

Accessing Government Support

Available Incentive Programs

Turkey offers various incentive programs to support companies aligned with strategic priorities:

  • Investment Incentives: Tax reductions, customs duty exemptions, and VAT exemptions for qualifying investments
  • R&D Support: Grants and tax incentives for research and development activities
  • Technology Development Zones: Special economic zones offering significant tax advantages for technology companies
  • Employment Incentives: Support for job creation in priority sectors

How to Qualify:

To access these programs, manufacturers typically need to:

  • Demonstrate alignment with strategic priorities
  • Commit to technology transfer or local R&D
  • Create employment opportunities
  • Meet domestic content requirements
  • Establish local partnerships where required

Navigating the Changing Regulatory Landscape

Key Regulatory Trends

As Turkey implements its strategic plan, expect regulatory evolution in several areas:

  1. Enhanced Domestic Content Requirements: Potential preference for locally manufactured devices in public procurement

  2. Accelerated Approval Pathways: Possible fast-track mechanisms for innovative technologies aligned with strategic priorities

  3. Stricter Post-Market Surveillance: More rigorous monitoring of device performance and safety

  4. Digital Compliance Requirements: Increased digital reporting and tracking obligations

  5. Sustainability Standards: New environmental and sustainability requirements

Staying Compliant

Best Practices:

  • Maintain close communication with the Turkish Medicines and Medical Devices Agency (TITCK)
  • Engage qualified Turkish regulatory consultants
  • Participate in industry associations to stay informed
  • Monitor official announcements and regulatory updates
  • Build relationships with key stakeholders in the Turkish healthcare ecosystem

Conclusion: Positioning for Success

Turkey's 12th Development Plan and 2025 Presidential Annual Program represent a comprehensive vision for transforming the country's healthcare sector. While these strategic initiatives introduce new requirements and expectations, they also create significant opportunities for medical device manufacturers willing to align with Turkey's priorities.

Success in the Turkish market increasingly depends on demonstrating:

  • Commitment to local value creation
  • Innovation and technological advancement
  • Digital health capabilities
  • Sustainability practices
  • Partnership and collaboration

Manufacturers who proactively adapt their strategies to support Turkey's healthcare transformation will be well-positioned to participate in one of the world's fastest-growing medical device markets.

Key Takeaways

✓ Turkey is pursuing healthcare self-sufficiency through increased domestic production and reduced import dependency

✓ Digital transformation and biotechnology represent priority investment areas

✓ Government incentives are available for companies aligned with strategic objectives

✓ Local manufacturing partnerships offer significant advantages

✓ Innovation and sustainability are increasingly important competitive differentiators

✓ Regulatory requirements continue to evolve to support strategic priorities

✓ Proactive engagement with Turkish stakeholders and planning for medium-term changes will be essential for success

For medical device manufacturers seeking to navigate Turkey's evolving regulatory landscape and capitalize on strategic opportunities, understanding these government priorities is essential. The coming years will see significant transformation in how medical devices are developed, manufactured, and regulated in Turkey, creating both challenges and opportunities for industry stakeholders.

Disclaimer: This blog post provides general information about Turkey's healthcare strategic plans. Specific regulatory requirements and incentive programs may change. Always consult with qualified regulatory and legal advisors for specific guidance related to your products and business situation.

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