How Turkey’s Medical Device Registration Has Changed for Foreign Firms in 2026

Introduction

Turkey has long been a strategic market for medical device manufacturers, bridging Europe, Asia, and the Middle East. In 2026, significant changes to the medical device registration process have taken effect, impacting foreign firms looking to enter or expand in this dynamic market. Understanding these updates is crucial for maintaining compliance and securing market access. This article provides a comprehensive overview of how Turkey’s medical device registration has changed for foreign firms in 2026, including new requirements, timelines, and strategic considerations.

Key Regulatory Changes in 2026

The Turkish Medicines and Medical Devices Agency (TITCK) introduced several amendments to align more closely with international standards, particularly the European Medical Device Regulation (MDR) and the International Medical Device Regulators Forum (IMDRF) guidelines. Foreign firms now face stricter documentation, local representation rules, and post-market surveillance obligations.

1. Mandatory Local Authorized Representative

Previously, foreign manufacturers could appoint a local distributor as their point of contact. In 2026, the requirement has been tightened: the authorized representative must be a legal entity registered in Turkey with explicit responsibility for regulatory compliance, adverse event reporting, and recall management. This representative cannot be a mere distributor; they must have a formal agreement and be listed on the registration certificate.

2. Enhanced Technical Documentation

Turkey now requires technical files to be submitted in Turkish or English, with summaries in Turkish. The documentation must include:

• Device description and intended purpose – clear and detailed.
• Design and manufacturing information – including quality management system certificates (ISO 13485).
• Clinical evaluation report – following MEDDEV 2.7/1 Rev.4 or equivalent.
• Risk management file – per ISO 14971.
• Labeling and instructions for use – must be in Turkish.

Foreign firms must ensure their technical files are up-to-date and submitted through the new online portal, ÜTS (Product Tracking System).

3. Updated Classification Rules

Turkey adopted the EU classification rules (Annex VIII of MDR) with minor adaptations. This means more devices are now classified as higher risk, requiring stricter conformity assessment procedures. For example, certain software and reusable surgical instruments have moved from Class I to Class IIa or IIb.

4. Post-Market Surveillance and Vigilance

Foreign firms must establish a post-market surveillance (PMS) system that includes:

• PMS plan and report – updated periodically.
• Periodic safety update reports (PSURs) – for Class IIb and III devices.
• Incident reporting – serious incidents must be reported within 15 days (or 2 days for life-threatening).

The authorized representative is responsible for maintaining these records and submitting them to TITCK upon request.

5. Transition Periods and Deadlines

Devices already registered before 2026 have a transition period until December 31, 2027, to comply with the new requirements. New applications from foreign firms must follow the 2026 rules immediately. Failure to comply may result in suspension or revocation of registration.

Step-by-Step Registration Process for Foreign Firms in 2026

Step 1: Appoint a Local Authorized Representative

Choose a Turkish entity with proven regulatory expertise. Ensure the agreement defines responsibilities, including liability for defective devices.

Step 2: Classify Your Device

Use the updated classification rules. If uncertain, request a classification opinion from TITCK (fee applies).

Step 3: Prepare Technical Documentation

Compile all required documents in Turkish or English with Turkish summaries. Engage a local consultant to verify completeness.

Step 4: Submit Application via ÜTS

The authorized representative submits the application electronically. Attach all documents, pay the fee, and track the status.

Step 5: Review and Inspection

TITCK reviews the submission within 90 days (may extend for complex devices). They may request additional information or conduct an audit of the manufacturing site.

Step 6: Registration Certificate

Once approved, a registration certificate is issued, valid for 5 years. Renewal requires updated documentation and evidence of PMS compliance.

Impact on Foreign Firms

The 2026 changes increase the cost and time to market for foreign firms. However, they also enhance market credibility and patient safety. Companies that adapt early can gain a competitive advantage. Key impacts include:

• Higher upfront investment – for documentation, local representation, and translation.
• Longer approval timelines – average 6-12 months versus 3-6 months previously.
• Greater post-market burden – ongoing reporting and vigilance obligations.
• Opportunity for harmonization – compliance with EU MDR may streamline Turkish registration.

Common Challenges and How to Overcome Them

Language Barrier

Technical documents must be in Turkish. Solution: hire professional translators with medical device expertise.

Local Representative Reliability

Finding a trustworthy representative can be difficult. Solution: vet candidates thoroughly, check references, and consider partnering with a regulatory consultancy.

Keeping Up with Regulatory Updates

TITCK frequently issues new guidelines. Solution: subscribe to TITCK newsletters, join industry associations, and work with local experts.

Conclusion

Turkey’s medical device registration has changed significantly for foreign firms in 2026, with stricter requirements for local representation, technical documentation, and post-market surveillance. While these changes present challenges, they also align Turkey with global best practices, ultimately benefiting patients and responsible manufacturers. Foreign firms should start preparing now by reviewing their device classifications, updating technical files, and securing a qualified authorized representative. By doing so, they can navigate the new landscape successfully and maintain access to this important market.