Market Overview
As a large country with a population of more than 82 million and a comprehensive public and private healthcare system designed to provide accessible and equitable healthcare to every resident of Turkey, the potential for any life sciences-related sector in the country can easily be described as advanced.
The Turkish medical device industry has grown rapidly over the last ten (10) years - ranking third in Central and Eastern Europe and second in MENA with a value of $2 billion.
Global medical device companies are located in Turkey with important production and organization activities and mostly use Turkey as a center for regional market access. The average annual growth rate of the Turkish medical device market was 17% between 2010 and 2020.
The Turkish Medicines and Medical Devices Agency ("TITCK"), under the Ministry of Health, and the Social Security Institution ("SSI") are the main actors in this field.
TİTCK mission is to regulate, supervise and control pharmaceuticals, medical devices, traditional herbal and supportive products, advanced therapeutic medical devices and cosmetic products in Turkey. The SSI on the other hand mainly with the implementation of social insurance and general health insurance in Turkey.
Latest Trends – Regulations
Full harmonization with EU Legislation
Although there are some minor differences due to the specificities of the Turkish healthcare system, it is an undeniable fact that the general regulation of the healthcare sector in Turkey, in particular the authorisation, registration and conformity rules, are compatible with EU legislation and rules. In the field of medical devices, Turkey has even taken steps to further align its legislation with the EU. In this context, Turkey published two (2) new regulations (collectively referred to as the "Regulations") in June 2021, namely the Medical Devices Regulation (the "MDR") and the Medical Devices In Vitro Diagnostic Regulation.
These regulations, which are fully harmonised with European Union (EU) legislation, aim to ensure a high level protection of safety of patients and users, high quality medical devices on the market, and a transparent, robust and sustainable medical devices market .
The Regulations require economic operators, manufacturers, authorised representatives and Turkish importers in Turkey to register in the EUDAMED database in order to increase transparency and improve traceability in the medical device industry. Manufacturers are required to register all medical devices with EUDAMED before placing them on the market. The obligations and requirements related to EUDAMED apply six (6) months after the EU Commission publishes a notification in the EU Official Journal that EUDAMED is fully operational and meets the functional specifications.
In addition, the definition of "medical device" is explained in detail in the MDR. Devices intended to obtain information by in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and devices intended specifically for the cleaning, disinfection or sterilisation of products as defined in the MDR are also defined as medical devices.
Some new product categories have been added to the definition of medical devices; for example, the definition of medical devices has been expanded and prognostic devices are now defined as medical devices. Products such as contact lenses, liposuction devices, facial and dermal fillers, laser devices, etc. are now considered medical devices.
The MDR also specifies that a medical device must meet increased quality requirements in order to be placed on the market. Manufacturers shall ensure that procedures are in place to meet the requirements of the MDR during mass production. Medical device manufacturers must establish, document, implement, maintain, update and continuously improve a quality management system to ensure compliance with the new regulations. The quality management system encompasses all parts and elements of the manufacturer's organization that deal with the quality of processes, procedures, and products. This system manages the structure, responsibilities, procedures, processes, and management resources necessary to implement the policies and activities required to ensure compliance. Manufacturers and importers of these products must also ensure that the products comply with the requirements of the MDR during stages such as post-market surveillance, and vigilance,.
In line with other product safety legislation, which has recently been updated to fully comply with the relevant EU legislation, the liability of exporters, importers and distributors of medical devices has also been addressed in detail in the MDR.
If the manufacturer is not established in Turkey or in the EU Member States, the product can only be placed on the market if the manufacturer designates an authorised representative.
Manufacturers are also required to have at least one person in their organization responsible for compliance, referred to as a "compliance officer," who has the necessary expertise in the field of medical devices.
One potential point of contention is that the MDR also contains rules for clinical research with medical devices. However, it should be noted that the Regulation on Clinical Trials of Medical Devices is also currently in force, which has led to some conflicting provisions between the two regulations. Nevertheless, with regard to these provisions, TİTCK considers that the MDR should be applied instead of the Medical Devices Clinical Trials Regulation, as the Medical Devices Clinical Trials Regulation is expected to be updated in line with the Medical Devices Regulation in the coming months.
Marketing and Promotion of Medical Devices
Marketing and advertising activities for medical devices are subject to the Ordinance on the Distribution, Advertising and Promotion of Medical Devices ("Medical Devices Advertising Ordinance"). According to this Regulation, medical devices sold, fitted or used in hearing aid centres, custom-made prosthesis and orthosis centres, opticians or denture laboratories (defined as "sales centres" in the said Regulation) may not be advertised directly or indirectly to the public.
Newspaper/magazine announcements made with the permission of the Agency and announcing that the device has been put on the market to healthcare professionals, and device notifications made by sales centers on their official websites are not covered by this restriction. However, it is prohibited to use the names of the Ministry and related agencies, as well as the names of health care institutions and individuals who have been involved in the research of the medical device, in medical device advertisements without approval.
Advertising for medical devices must contain the following information:
- Information that the display clearly refers to the device;
- The declaration of conformity of the device, its EC certificate, the designation and information of the device in the documentation, such as a technical file, and the designations and information of compatible devices;
- Information on the label and in the instructions for use of the product that is consistent with its intended purpose;
- Scientific reports and certificates that refer to the advertisement, date of issue, contact information, and the author's field of expertise (person or institution); and
- Evidence-based medical information on any therapeutic effect of the product.
On the other hand, in addition to the Medical Devices Advertising Regulation, the MDR also contains some provisions that apply to the advertising of medical devices. More specifically, according to the MDR, the advertising of medical devices must not contain misleading texts, names, trademarks, images and figurative or other signs about the intended use, safety and performance of the medical devices. Some of the prohibited acts include the following (i) attributing functions and properties to the product that it does not possess, (ii) creating a false impression about functions or properties related to treatment or diagnosis that the product does not possess, (iii) failing to inform or misinforming the user or patient about a potential risk associated with the intended use of the device, and (iv) propose uses for the device other than the intended use for which a conformity assessment has been carried out
The Turkish Government's View of the Medical Devices Arena
Background
Since the main player in the Turkish medical devices sector is the public sector, in order to better understand the emerging and expected trends in this field, it is necessary to analyze the government's perspective.
It is well known that the Turkish government's strategy for the medical device industry has been shaped by the government's long-standing localization program policy to reduce dependence on imports and increase local production. To achieve this, the government has made substantial investments in healthcare infrastructure and services, promoted the idea of an ideal location for medical tourism and a favorable regulatory environment aligned with international standards, and strongly supported biotechnology initiatives. Needless to say, these policies will have a huge impact on the future of the industry in Turkey.
The "President's Annual Program for 2022" ("Annual Program"), prepared by the Ministry of Treasury and Finance and the Strategic Budget Presidency, was published in the Official Gazette on 20 October 2021.
Although the Annual Program is quite comprehensive, some of the specific objectives that the government believes could be considered critical to the future of the medical devices sector are as follows:
- An accredited centre of excellence will be established to provide analysis, verification, testing and measurement services in the areas of medical device research and development, preclinical studies, prototype development, manufacturing and post-production processes.
- Programs and events on incentives and intellectual property rights will be organized to accelerate the commercialization process, especially for university researchers.
- An infrastructure for the production of chemical, plant, biological and radiopharmaceutical (nuclear) raw materials is being developed.
- Infrastructure and skills will be developed to strengthen R&D activities for biotechnological medicines.
- Ensuring that clinical research conducted prior to licensure is included in the scope of R&D activities without limitation and differentiating R&D incentives for clinical research.
- Preclinical research centres, which hold an internationally recognised certificate of good laboratory practice, are established to conduct research and development studies on medicinal products and medical devices prior to clinical trials.
- In order to increase the share of international funding (e.g. EU funds and NIH funds) in clinical research, memberships in international networks are sought to increase Turkey's visibility at the international level.
Moreover, from the government's perspective, the Covid 19 pandemic has demonstrated the importance of R&D activities, the capacity and diversity of the pharmaceutical and medical device industries, and their ability to respond quickly to emergencies. The need for a decentralization policy on vaccines, drugs, protective equipment and medical devices has become even more evident during the pandemic. All the points mentioned in the annual programme illustrate the government's aim to increase the local share in the development and manufacturing phases of medical devices.
A specific area of concern: Data Protection
Although the Turkish medical device industry faces several problems from developing countries (e.g., receivables problem of medical device companies supplying products to public healthcare institutions), it should be noted that a specific area of data protection may be of concern to medical device industry players due to the increasing use of digitalization and cloud technologies.
In Turkey, the protection of personal data (including personal health data) is regulated by the Personal Data Protection Law. According to this law, personal data related to health or sexual orientation are more strictly protected than other types of data; however, they can still be processed with the explicit consent or by authorised institutions and organisations for the protection of public health, preventive medicine, medical diagnosis, treatment and care services. This can sometimes lead to practical difficulties for medical device providers collecting vigilance data and complaints as part of their quality strategy, as they may need to obtain explicit consent from patients to collect and store information, and process, share and transmit data abroad to their global headquarters.
In addition, Presidential Circular on Information and Communication Security Measures No. 2019/12 provides that critical information and data such as population, health and contact registration information, as well as genetic and biometric data should be stored securely in Turkey. Considering that cloud technologies where data is not necessarily stored in Turkey are heavily used in medical technology, this could pose some issues especially for medical technology companies working with public hospitals. Occasionally, this could lead to hurdles in tenders conducted by public healthcare institutions.
