Understanding Medical Device Regulation in Turkey: A Comprehensive Guide
Turkey's strategic location and alignment with international standards make it a significant player in the global medical device market. Over the years, Turkey has developed a robust regulatory framework designed to ensure the safety, efficacy, and quality of medical devices. Its alignment with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) highlights its commitment to international best practices.
This guide provides an in-depth overview of Turkey's medical device regulations, insights into importing and exporting devices, and references to trade agreements with key global markets, including the EU, UK, USA, and Canada.
Regulatory Authority and Framework
The Turkish Medicines and Medical Devices Agency (TMMDA), operating under the Ministry of Health, oversees medical device regulation in Turkey. Its responsibilities include registration, market surveillance, and ensuring compliance with Turkish regulations.
Key Legislative Instruments
Law on Product Safety and Technical Specifications (No. 7223): Governs the safety, performance, and market surveillance of medical devices, ensuring products meet technical specifications before entering the Turkish market.
Medical Device Regulation: Establishes specific requirements for registration, labeling, post-market surveillance, and compliance for manufacturers, importers, and distributors.
Ürün Takip Sistemi (ÜTS): Turkey’s national electronic system for registering and tracking medical devices, akin to the EU's EUDAMED database. The ÜTS system ensures transparency and facilitates traceability of devices across the supply chain.
EU-Turkey Customs Union Agreement and 2022 Updates
The EU-Turkey Customs Union Agreement, first established in 1995, harmonized Turkey's medical device regulations with those of the EU. The 2022 updates further streamlined regulatory alignment, benefiting stakeholders in the Turkish medical device market.
Key Provisions of the Agreement
Mutual Recognition of Certificates:
EU Notified Body certificates issued under MDR/IVDR are accepted in Turkey.
Turkish Notified Body certificates are recognized in the EU, facilitating easier market entry for Turkish manufacturers.
Exemption from Appointing an Authorized Representative:
EU manufacturers do not need a Turkish Authorized Representative to place devices on the Turkish market.
Similarly, Turkish manufacturers do not require an EU Authorized Representative to market devices in the EU.
Streamlined Trade:
The agreement reduces regulatory barriers, fostering smoother trade between Turkey and EU member states.
Enhanced Market Surveillance:
Both Turkey and the EU are committed to post-market surveillance, ensuring ongoing safety and compliance of medical devices.
Impact of EU-Turkey Harmonization
This alignment benefits both Turkish and EU manufacturers by reducing duplicative requirements and administrative burdens. Additionally, it promotes the free movement of medical devices across borders, boosting trade volume and enhancing patient access to innovative technologies.
Device Classification and Registration
Medical devices in Turkey are categorized into four classes based on risk, following the EU classification system:
Class I: Low-risk devices (e.g., bandages, stethoscopes).
Class IIa: Medium-risk devices (e.g., infusion pumps, diagnostic ultrasound machines).
Class IIb: Higher-risk devices (e.g., ventilators, anesthesia machines).
Class III: High-risk devices (e.g., pacemakers, implantable defibrillators).
Registration Requirements
Manufacturers must submit a comprehensive dossier to register their devices in ÜTS. This includes:
Technical File: Detailed information about the device’s design, intended use, and safety features, demonstrating compliance with applicable standards.
ISO 13485 Certification: Proof of compliance with international quality management system standards.
Declaration of Conformity: A formal statement confirming compliance with regulatory requirements.
Labeling and IFU: Labels and Instructions for Use (IFU) must be in Turkish.
Timelines for Registration
Class I Devices: Registration typically takes 2–4 weeks.
Class IIa, IIb, and III Devices: May take 3–6 months, depending on documentation complexity.
Costs Associated with Registration
Registration fees depend on the device’s classification, with higher-risk devices incurring higher costs. Additional costs may include auditing expenses and consulting fees to ensure compliance with ISO 13485 and MDR requirements.
How to Import Medical Devices into Turkey
Importing medical devices into Turkey requires adherence to specific regulatory requirements.
Step 1: Register in the ÜTS System
All devices must be registered in ÜTS before importation. Required documentation includes the CE Certificate, Declaration of Conformity, and Turkish-language IFU.
Step 2: Appoint an Authorized Representative
Foreign manufacturers must appoint a Turkish Authorized Representative to liaise with the TMMDA and ensure compliance.
Exception for EU Manufacturers:
EU manufacturers, under the EU-Turkey Customs Union Agreement, are exempt from this requirement.
Step 3: Importer Responsibilities
Importers must:
Verify ÜTS registration.
Ensure labeling meets Turkish regulatory standards.
Maintain records for traceability and post-market surveillance.
Step 4: Customs Clearance
Importers must submit a commercial invoice, packing list, and proof of ÜTS registration to clear customs.
Exporting Medical Devices from Turkey
Turkey’s alignment with EU standards and strong manufacturing capabilities make it a significant exporter of medical devices.
1. Exporting to the European Union (EU)
Under the EU-Turkey Customs Union Agreement, CE-marked devices can enter the EU without additional conformity assessments.
2. Exporting to the United Kingdom (UK)
Post-Brexit, Turkey and the UK have a bilateral trade agreement. CE marking is recognized temporarily, but manufacturers should prepare for UK Conformity Assessed (UKCA) marking.
3. Exporting to the United States (USA)
Turkey and the United States do not have a free trade agreement for medical devices. However, the Trade and Investment Framework Agreement (TIFA) provides a mechanism for addressing trade and investment issues. Turkish manufacturers exporting to the U.S. must comply with FDA regulations, including:
Device registration and listing.
Adherence to regulatory pathways (e.g., 510(k), PMA).
4. Exporting to Canada
Turkey and Canada do not have a formal free trade agreement for medical devices. However, they maintain bilateral economic cooperation through the Joint Economic and Trade Committee (JETCO). Turkish manufacturers must:
Obtain a Medical Device License (MDL) for Class II–IV devices.
Ensure ISO 13485 certification.
Language and Labeling Requirements
To ensure accessibility and safety, Turkey requires:
Labels and IFU: Must be in Turkish, including device name, warnings, and usage instructions.
Professional Use Devices: Labels can include EU languages for healthcare professionals, but IFUs must be in Turkish.
Implant Cards and FSNs: These must be in Turkish for clear communication with patients.
Auditing and Post-Market Surveillance
Turkey enforces strict post-market surveillance and auditing requirements to maintain device safety:
Market Monitoring: Devices are monitored to ensure ongoing compliance.
Adverse Event Reporting: Manufacturers must report adverse events promptly.
Audits: The TMMDA conducts audits to verify compliance with quality and regulatory standards.
Opportunities in the Turkish Medical Device Market
Turkey’s healthcare sector is rapidly growing, driven by:
Increased Healthcare Spending: Rising demand for advanced medical devices.
Strategic Location: Turkey serves as a bridge between Europe, Asia, and the Middle East.
Regulatory Alignment: Harmonization with EU standards simplifies international trade.
Conclusion
Turkey’s medical device regulations have been strengthened through alignment with EU MDR and IVDR. The 2022 updates to the EU-Turkey Customs Union Agreement further facilitate trade, enhancing opportunities for manufacturers.
For companies entering Turkey or exporting from Turkey to global markets, understanding and complying with regulatory frameworks is crucial. Collaboration with Turkish Authorized Representatives and regulatory experts ensures seamless market entry.
By adhering to these guidelines, businesses can leverage Turkey’s growing prominence as a global hub for medical technology.