Turkey medical device regulations
Official sources linkedTITCK rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| IVD Medical Device Regulation, Official Gazette No. 31499 | Turkish In Vitro Diagnostic Medical Device Regulation Turkish IVD framework aligned with Regulation (EU) 2017/746, including risk classification, conformity assessment, performance evidence, registration, and post-market requirements. | General | May 26, 2022 | Official |
| Medical Device Regulation, Official Gazette No. 31499 | Turkish Medical Device Regulation Turkey’s core medical device regulation, aligned with Regulation (EU) 2017/745, covering classification, conformity assessment, economic operators, UDI, market access, and post-market obligations. | General | May 26, 2021 | Official |
| ÜTS Requirements | Product Tracking System Registration Requirements Requires relevant manufacturers, authorized representatives, importers, devices, and conformity information to be recorded and maintained in Turkey’s national Product Tracking System (ÜTS). | Registration | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
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Compare existing evidence against Turkey needs.
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