Regulatory Authority
TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) – Turkish Drug and Medical Devices Agency
Classification
Medical Devices I, IIa, IIb, III
In vitro diagnostic reagents: A, B, C, D
Quality system
ISO 13485:2016:2016
To market medical and in vitro diagnostic devices in Turkey, product registration with the Turkish Medicines and Medical Devices Agency (TITCK) is required.The registration process requires the submission of a technical and administrative dossier via the ÜTS (Ürün Takip Sistemi) electronic registration system.
The main elements of the registration dossier include the EC certificate, ISO 13485:2016 certificate, technical file, and declaration of conformity with applicable safety and performance requirements. The dossier content may vary according to the risk class of the device. For example, low-risk (Class I) devices follow a simpler registration procedure, based mainly on the manufacturer’s declaration. For higher-risk devices (Classes IIa, IIb and III), more detailed documentation is required and additional assessments by the regulatory authority may be required.
Applicant
Foreign manufacturers, including those based in the European Union, must appoint an Authorised Representative (AR) based in Turkey to legally place their devices on the Turkish market.
Timeframes and Costs
Registration times for Medical Devices vary depending on the risk class and complexity of the dossier. Generally, Class I devices can be registered in a few weeks, while for higher classes the process can take up to six months.
Registration costs vary according to device category but are generally higher for class IIb and III devices.
Validity
Registration is valid indefinitely and renewal is only required in cases of significant changes to the product, renewal of the EC certificate or in the event of regulatory changes.
Documentation Language and Labelling
Documentation, labelling and instructions for use must be provided in the Turkish language.
Useful information
Even if the registration procedure is carried out by the Local Authorized Representative, the owner of the registration is the manufacturer.
