UTS (Product Tracking System) Registration Alone Is Not Sufficient: Technical Assessment Required for Classification as a Medical Device

UTS (Product Tracking System) Registration Alone Is Not Sufficient: Technical Assessment Required for Classification as a Medical Device

In customs procedures, certain products being classified as medical devices solely on the grounds that they lack UTS registration can result in additional tax assessments and administrative penalties. A ruling by the Istanbul 6th Tax Court draws an important boundary against this practice.

The court ruling emphasizes in summary that whether a product is a medical device cannot be determined solely by looking at its UTS registration status. The absence of UTS registration does not in itself mean that the product falls within the scope of the Medical Devices Regulation or the In Vitro Diagnostic Medical Devices Regulation. For this reason, the administration is required to carry out a technical assessment as to whether the product should be classified as a medical device.

The ruling further states that, taking into account the nature and technical characteristics of the goods covered by the import declaration, an additional assessment and penalty decision based solely on the absence of UTS registration is not in accordance with the law. As a result, the case was upheld and both the administrative act and the penalties imposed by the administration were annulled. The appeal route against this ruling also remains open.

This ruling constitutes an important precedent for products that are automatically classified as medical devices on the grounds of lacking UTS registration. It signals that the legal avenue remains open for operators in similar situations to challenge penalties and additional assessments imposed without a technical assessment having been carried out.