Turkey has its own medical device regulatory framework. Since 2021, Turkey operates under the Turkish Medical Device Regulation (TÜMER), which aligns with EU MDR 2017/745 but is administered separately by the Turkish Medicines and Medical Devices Agency (TİTCK). Products entering the Turkish market require documentation in Turkish — and that documentation must use terminology consistent with TİTCK expectations, not informal translations of EU regulatory language.

For pharmaceutical content, Turkey's regulatory authority is the same body — TİTCK — which oversees drug approval, labeling requirements, and pharmacovigilance reporting. Turkish labeling and patient information leaflets must meet specific format and readability requirements that differ from EU norms.

This means Turkish medical translation requires more than bilingual competence. It requires knowledge of the Turkish regulatory environment, familiarity with TİTCK documentation standards, and translators who work in this domain regularly.

 

 

• Medical Devices
  - IFUs / Instructions for Use: For submission to TİTCK and for end-user documentation
  - Labels and on-device text: Character-precise, format-compliant
  - Technical documentation sets: Including risk files, design documentation, and performance evaluations
  -CE technical files: Where Turkish market access follows EU certification
  -Post-market surveillance documentation

• Clinical & Regulatory
  -Clinical investigation protocols and reports
  -Investigator brochures and informed consent forms
  -CAPA documentation and deviation reports
  -SOPs and quality management documentation
  -Regulatory submissions and correspondence with TİTCK

• Pharmaceutical
  -Summary of Product Characteristics (SmPC): Turkish version for market registration
  -Patient Information Leaflets (PIL): Readability-compliant
  -Labeling and packaging content
  -Pharmacovigilance and safety reports
  -Drug approval dossier components

• Healthcare & Life Science
  -Laboratory procedures and analytical methods
  -Healthcare tender documentation: specifications, compliance requirements
  -PPE product catalogues and safety data sheets
  -Medical training materials and e-learning content
  
  

▮ Apart from Turkish, which languages do you cover for medical translation?
We work across 40+ languages including German, French, Italian, Spanish, Dutch, Polish, Romanian, Arabic, Persian, Hebrew, and Greek. For multilingual medical programmes requiring multiple language pairs simultaneously, we manage all pairs through a single point of contact with shared terminology governance and consistent regulatory alignment across markets.