Turkey: A Rising Star in the Medical Devices and Biotech Industry

Turkey is a country with a large population, a comprehensive healthcare system, and a strategic location between Europe and Asia. These factors make it an attractive market for medical device and biotechnology companies, especially those from the European Union (EU).

Turkey has aligned its regulatory framework for medical devices and biotechnology products with that of the EU, which means that devices and products that have successfully passed conformity assessment in Europe and bear a CE mark also meet the Turkish requirements. This simplifies the market access process and reduces the costs and risks for manufacturers.

Turkey also offers strong government support for the development of the medical devices and biotechnology industry, as well as incentives for foreign direct investment, research and development, and innovation. Turkey has hosted 750,000 medical tourists from 60 countries in 2016 and had a turnover of $5.8 billion1. This is expected to increase to one million patients in five years, creating a high demand for quality and affordable medical devices and biotechnology products.

Turkey has a vibrant and dynamic medical devices and biotechnology sector, with more than 1,000 local manufacturers, 2,300 importers, and 700 companies that do both1. Many global medical device and biotechnology companies have established their presence in Turkey with significant manufacturing and management activities, using Turkey as a hub to access regional markets. They have also formed successful partnerships with local companies to grow in the region, capitalizing on their experience and networks.

Some of the key segments and trends in the Turkish medical devices and biotechnology industry are:

• Medical devices: Turkey has a large and growing market for medical devices, with a value of $2 billion in 20202. The average annual growth rate of the Turkish medical device market was 17% between 2010 and 20202. The main drivers of this growth are the increasing healthcare spending, the aging population, the rising prevalence of chronic diseases, the expansion of public and private healthcare facilities, and the adoption of new technologies. The most in-demand medical devices in Turkey are diagnostic imaging equipment, orthopedic implants, cardiovascular devices, dental products, and surgical instruments.
• Biotechnology: Turkey has a strong potential for biotechnology, with a well-educated and skilled workforce, a rich biodiversity, and a supportive regulatory environment. Turkey has invested in biotechnology research and development, especially in the fields of health, agriculture, and environment. Turkey has also established biotechnology clusters, parks, and incubators to foster innovation and collaboration among academia, industry, and government. Some of the prominent biotechnology products and services in Turkey are biosimilars, vaccines, diagnostics, gene therapy, and contract research and manufacturing.

Turkey is a rising star in the medical devices and biotechnology industry, offering opportunities for both local and foreign companies to enter and expand in this lucrative market. With its harmonized regulations, government support, market potential, and industry capabilities, Turkey is poised to become a regional leader and a global player in this field.

What are some challenges for medical devices and biotech industry in Turkey?

• Regulatory compliance: Turkey has aligned its regulatory framework for medical devices and biotechnology products with that of the EU, which means that devices and products that have successfully passed conformity assessment in Europe and bear a CE mark also meet the Turkish requirements1. However, this also means that Turkey has to keep up with the changes and updates in the EU legislation, such as the new Medical Devices Regulation and the Medical Devices In Vitro Diagnostic Regulation that were published in June 2021. These regulations introduce new obligations and requirements for economic operators, manufacturers, authorized representatives and Turkish importers, such as registering in the EUDAMED database and providing more clinical evidence and post-market surveillance data2. These regulations also impose stricter rules on the classification and risk assessment of medical devices and biotechnology products, which may affect their market access and reimbursement status.
• Market competition: Turkey has a large and growing market for medical devices and biotechnology products, with a value of $2 billion in 2020. The average annual growth rate of the Turkish medical device market was 17% between 2010 and 2020. This attracts many global and local players to enter and expand in this lucrative market, creating a high level of competition and price pressure. Turkey also has a strong domestic production capacity, with more than 1,000 local manufacturers, 2,300 importers, and 700 companies that do both. These local companies have the advantage of lower production costs, faster delivery times, and better understanding of the local market needs and preferences. Foreign companies have to compete with these local companies by offering innovative, high-quality, and cost-effective products and services, as well as forming strategic partnerships and alliances with them.
• Supply chain and infrastructure: Turkey has faced some challenges in ensuring the availability and quality of raw materials, components, and equipment for the medical devices and biotechnology industry, especially during the COVID-19 pandemic. Turkey relies heavily on imports for some of these items, which makes it vulnerable to disruptions in the global supply chain and fluctuations in the exchange rates. Turkey also needs to improve its infrastructure for research and development, testing, and certification of medical devices and biotechnology products, as well as its logistics and distribution network to ensure timely and efficient delivery of these products to the end-users.
• Healthcare system: Turkey has a comprehensive public and private healthcare system that covers more than 99% of its population. However, the system also faces some problems, such as access to treatment, long waiting times, cost of accessing treatment, and lack of staff. These problems affect the demand and utilization of medical devices and biotechnology products, as well as the satisfaction and trust of the patients and healthcare providers. Turkey also has tobalance its healthcare budget and spending, as well as its reimbursement policies and pricing mechanisms, to ensure the sustainability and affordability of the healthcare system and the medical devices and biotechnology industry.

What are some legal challenges for foreign companies in Turkey's biotech industry?

• Regulatory compliance: Foreign companies have tocomply with the Turkish regulatory framework for biotechnology products, which is aligned with the EU framework (MDR, IVDR). This means that they have to meet the same standards and requirements as the EU manufacturers, such as registering in the EUDAMED database, providing clinical evidence and post-market surveillance data, and labeling and UDI rules. However, this also means that they have to keep up with the changes and updates in the EU and Turkish legislation, which may introduce new obligations and rules that affect their market access and reimbursement status.
• Market competition: Foreign companies face a high level of competition from both local and global players in the Turkish biotech market, which is large and growing. They have to offer innovative, high-quality, and cost-effective products and services that meet the customer needs and preferences, as well as the pricing and reimbursement policies. They also have to protect their intellectual property rights and form strategic partnerships and alliances with local companies to gain market share and access.
• Supply chain and infrastructure: Foreign companies may encounter difficulties in ensuring the availability and quality of raw materials, components, and equipment for the biotech industry, especially during the COVID-19 pandemic. They may also face disruptions in the global supply chain and fluctuations in the exchange rates. They may also need to improve their infrastructure for research and development, testing, and certification of biotech products, and to access the biotech clusters, parks, and incubators in Turkey.
• Healthcare system: Foreign companies have to interact with the Turkish healthcare system, which is comprehensive but also faces some problems, such as access to treatment, long waiting times, cost of accessing treatment, staff shortage, and satisfaction and trust of the patients and healthcare providers. They also have to balance their healthcare system and the biotech industry, and to ensure the sustainability and affordability of both.

How a legal firm can overcome these challenges and help the clients?

• Regulatory compliance: A legal firm can help the clients to understand and comply with the Turkish regulatory framework for medical devices and biotechnology products, which is aligned with the EU framework (MDR, IVDR). A legal firm can assist the clients with the conformity assessment processes, the registration and notification procedures, the clinical evaluation and investigation requirements, the risk management and quality management systems, the post-market surveillance and vigilance obligations, and the labeling and UDI rules. A legal firm can also help the clients to monitor and adapt to the changes and updates in the EU and Turkish legislation, such as the common specifications for the Annex XVI product groups.
• Market competition: A legal firm can help the clients to enter and expand in the Turkish market, which is large and growing but also highly competitive. A legal firm can advise the clients on the market opportunities and challenges, the customer needs and preferences, the pricing and reimbursement policies, and the intellectual property rights protection. A legal firm can also help the clients to form strategic partnerships and alliances with local manufacturers, importers, distributors, and healthcare providers, and to negotiate and draft the contracts and agreements with them.
• Supply chain and infrastructure: A legal firm can help the clients to ensure the availability and quality of raw materials, components, and equipment for the medical devices and biotechnology industry, especially during the COVID-19 pandemic. A legal firm can assist the clients with the import and export procedures, the customs and tax regulations, the exchange rate fluctuations, and the dispute resolution mechanisms. A legal firm can also help the clients to improve their infrastructure for research and development, testing, and certification of medical devices and biotechnology products, and to access the biotechnology clusters, parks, and incubators in Turkey.
• Healthcare system: A legal firm can help the clients to interact with the Turkish healthcare system, which is comprehensive but also faces some problems. A legal firm can advise the clients on the healthcare spending and budget, the access to treatment and waiting times, the cost of accessing treatment and staff shortage, and the satisfaction and trust of the patients and healthcare providers. A legal firm can also help the clients to balance their healthcare system and the medical devices and biotechnology industry, and to ensure the sustainability and affordability of both.