Documents Required for UTS Company Registration
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UTS Product Tracking System Consultancy
Documents Required for UTS Company Registration
UTS (Urun Takip Sistemi, the Turkish Product Tracking System for medical devices) is the database where every medical device placed on the Turkish market must be recorded. To register a company and its products, the Turkish Ministry of Health requires a defined document set. The core documents are:
- EC certificate for the product, issued by a notified body
- EC declaration of conformity signed by the legal manufacturer
- ISO 13485 quality management system certificate
- Product catalogue showing the device range and references
- Instructions for use (IFU) for each model or reference
- Turkish translation of every document not originally in Turkish
Turkish Translation Is Not Optional
Foreign manufacturers often ask whether English documents are accepted. They are not. The UTS record is read by Turkish regulators, importers, hospital procurement officers, and end users, and the law requires Turkish documentation for labelling, IFU, and key conformity documents. A properly prepared Turkish translation prevents record rejections and protects the device's shelf life in the system.
Document Quality Prevents Rework
The most common reason for UTS registration delays is document mismatch, for example a CE declaration listing a scope different from the EC certificate, or an IFU missing the GMDN code referenced in the technical file. A pre-submission review is the cheapest quality control step in the process.
How Sistem Patent Kalite Helps
Sistem Patent Kalite has served Turkish and international medical device clients since 1999. Our team reviews every document, prepares the Turkish translations, assembles the UTS submission package, and uploads the records under the company's authorised electronic signature. We work with manufacturers, importers, and authorised representatives, and we follow up with the Ministry of Health if the submission is returned for clarification.
Contact Us
For the full document list tailored to your company type, or for any UTS question, contact our specialists.
