Medical Device Import Permit
UTS registration, TITCK obligations and import inspection processes for medical devices and in vitro diagnostic devices.
Related HS chapters
Chapter information is indicative; the actual obligation depends on the product's function.
Unlike other product groups, medical device imports fall under the regulatory authority of the Turkish Medicines and Medical Devices Agency. The product must be registered in the Product Tracking System, the importer's authorised representative relationship must be established, and class-appropriate certification must be complete. If any one of these three conditions is missing, the import stops.
What this service covers
- Determination of device class (I, IIa, IIb, III) and regulatory scope
- UTS company and product registration
- Establishing authorised representative and importer registration links
- Review of CE certificates and notified body documentation
- Management of inspection and permit processes at import
- Turkish labelling and user manual compliance
How the process works
How the process works
Class and scope assessment
We determine the device's risk class and applicable legislation, and set out the required document package.
UTS registration
We complete company registration, product registration and authorised representative links in the system.
Import inspection
We file the application at the import stage and respond to agency requests.
Customs and market placement
We obtain the reference number and confirm label and manual compliance before market placement.
Most common mistakes
Most common mistakes
The items below are the rejection grounds we encounter most often in practice. We check every one of them before filing.
- Shipping the product before it is registered in UTS
- Authorised representative relationship not approved in the system
- The imported model not being covered by the scope of the CE certificate
- Missing Turkish user manual or inadequate translation quality
Free preliminary assessment
Do you have a shipment in this product group?
Send us your HS code and product details. We will confirm in writing whether it is subject to inspection, which documents you will need and how long it will take.
Let's talk before your shipment leaves
The permit process becomes most expensive when it starts after the goods reach the port. Send us the proforma invoice and we'll tell you today what timeline to work to.