We utilize years of hands-on experience to ensure our clients to get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations  and all post-registration, follow-up processes via "Product Tracking  System (UTS)" Our experienced consultants can review your documents, register your medical device or IVD, as required and respond to any questions or concerns from the Competent Authorities.

For the past four years, Ardis has been supporting medical device and IVD companies with market entry strategies in Turkiye. Our services include identifying, screening, and engaging potential distributors through targeted research and interviews, providing companies with essential insights and connections to establish a strong market presence.

Ardis provides its partners with comprehensive guidance on Turkish regulatory requirements for medical devices. We offer consulting services to help our customers understand the operational procedures of regulatory bodies in Turkey and the classification criteria for medical devices, ensuring smooth and compliant market entry.

Medical devices intended to be sold in Turkey must be registered either through a local office or an authorized representative incorporated in the country Foreign manufacturers without a presence in Turkey need a local representative to fulfill this requirement. Ardis, as an in-country representative, holds the registration on behalf of foreign companies and manages all necessary procedures with Turkish authorities.

Key requirements include:

1) All medical devices must be registered with the MoH in the  UTS (Product Tracking System ) and registrations and notifications  must be made to TITUBB (Turkiye Drugs and Medical Devices National Database).

2) A local representative, known as the "Registration Holder," must submit UTS registrations.

3) The local representative must be a registered entity in Turkey and must have a company registration in the EBS  (Electronic Application System). 

Ardis  enables medical manufacturers in Turkey to leverage the expertise of  external partners to grow their businesses and bring industry-changing solutions to the market. We have been supporting local manufactures in Euorope with answering questions on Key Opinion Leader (KOL) searches and interviews, logistics issues and other topics before they can actually start selling in a market.