What is TITCK?

TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency) is Turkey's national regulatory authority for medicines and medical devices. Established in 2011 under the Ministry of Health, TITCK is responsible for registration, market surveillance, and post-market control of all medical devices placed on the Turkish market. Turkish medical device manufacturers who export to the EU must comply with EU MDR and obtain CE marking from a Notified Body — TITCK oversees the domestic market, while CE certification governs export eligibility.

CE Marking: The Standard for Turkish Exports

The vast majority of Turkish medical device manufacturers who export internationally hold CE marking under EU MDR (EU 2017/745) or the legacy MDD (93/42/EEC). CE marking is issued by EU-recognised Notified Bodies (such as BSI, TÜV SÜD, Dekra, or SGS) and confirms that the device meets EU safety and performance requirements. For foreign buyers, CE marking is the primary quality assurance mechanism and is recognised by regulatory authorities in over 80 countries worldwide.

ISO 13485: Quality Management System Certification

ISO 13485 is the international standard for quality management systems in medical device manufacturing. Most serious Turkish medical device exporters hold ISO 13485 certification, which is audited annually by accredited certification bodies. ISO 13485 compliance demonstrates that the manufacturer has documented processes for design control, production, complaint handling, and corrective action. Foreign buyers should always request the current ISO 13485 certificate and verify its validity date and scope.

How Foreign Buyers Can Verify Turkish Manufacturer Compliance

Foreign buyers can verify Turkish manufacturer compliance through several mechanisms. First, request the current CE certificate directly from the manufacturer and verify it on the Notified Body's public database (e.g., NANDO database for EU Notified Bodies). Second, request the current ISO 13485 certificate and verify with the issuing body. Third, check the EUDAMED database (eudamed.ec.europa.eu) for registered devices once EUDAMED is fully operational. Fourth, request the Declaration of Conformity (DoC), which is a manufacturer's formal declaration of compliance. Fifth, for high-value procurement, consider conducting or commissioning a factory audit.

TITCK Registration for the Turkish Domestic Market

For devices sold within Turkey, manufacturers register products in the TITCK registration system. Turkish manufacturers must obtain a TITCK registration number for domestically sold products. However, for exported products, the relevant certification is CE marking or the destination country's registration — not the TITCK domestic registration. Foreign buyers should not confuse a TITCK registration number with CE certification. CE marking from a recognised EU Notified Body is the internationally recognised quality benchmark.

Key Certifications to Request from Turkish Manufacturers

When evaluating Turkish medical device manufacturers as potential suppliers, foreign buyers should systematically request: (1) CE Certificate from an EU Notified Body with device scope and validity date, (2) ISO 13485 Certificate with scope and validity date, (3) Declaration of Conformity for each specific product, (4) Technical file summary or product datasheet with performance specifications, (5) Clinical evaluation summary or literature evidence for Class IIa and above devices, (6) Sample batch records, test reports, or sterilisation certificates for sterile products.

The Turkish Medical Index: A Verified Exporter Platform

Turkish Medical Index (turkishmedicalindex.com) provides foreign buyers with access to verified Turkish medical device manufacturers, complete with company profiles, product categories, export markets, and certification status. All listed companies have been screened for active CE marking and manufacturing credentials. The platform eliminates the time-consuming cold search process and connects international buyers directly with pre-verified Turkish exporters.

Conclusion

Turkey's regulatory framework for medical device exports is built on internationally recognised standards: CE marking, ISO 13485, and the EU's Declaration of Conformity system. For foreign buyers, understanding these mechanisms — and how to verify them — is the foundation of safe, compliant procurement from Turkish manufacturers. Turkish Medical Index exists to make this process simpler, faster, and more reliable.