Türkiye's medical device framework is aligned with the EU: market access is based on MDR 2017/745 and IVDR 2017/746, with CE marking as the legal basis and registration managed through the Turkish Medicines and Medical Devices Agency (TİTCK) via the Product Tracking System, the ÜTS. A common assumption is that entering the market means handing registration to a local distributor but a foreign manufacturer does not need a distributor to register. It needs a Türkiye-based Authorized Representative, and these are two different roles.

A manufacturer based outside Türkiye cannot file ÜTS registrations directly unless it has a Turkish subsidiary; instead it appoints a Türkiye-based Authorized Representative, who submits the registration and becomes the accountable party before TİTCK. A distributor, by contrast, is a commercial operator that sells the device. 

The strategic risk arises when a single local partner holds both the distribution relationship and the ÜTS registration, tying market access to a commercial contract: if the relationship ends, transferring the registration can mean product withdrawal and re-registration. Appointing an independent Türkiye-based Authorized Representative keeps the registration portable and under the manufacturer's own control, while distributors can be changed separately.

🔗 For the detailed version, please visit our LinkedIn article: https://www.linkedin.com/pulse/can-foreign-manufacturer-register-t%25C3%25BCrkiye-without-local-consulting-fw6ef/

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