Medical Device Import Controls under Communiqué 2026/16

Medical device import sits in Türkiye at the intersection of two regulatory layers: the medical device legislation governing the product's placing on the market, and the foreign-trade controls inspecting the import. The instrument mapping this intersection annually is the medical device leg of the product safety and inspection communiqué family; for the 2026 period that role belongs to the medical device import inspection communiqué within the 2026-numbered family. The communiqué's annex lists which GTİP codes fall under control; before the declaration a conformity application is filed through TAREKS; the assessment runs over the device's CE marking, registration status and labelling integrity. This article explains the communiqué's scope, the TAREKS document set, the way ÜTS registration ties into the customs flow, and nonconformity scenarios. A practical frame is offered for distributors, manufacturer representatives, clinical research teams and customs operations.

Who is this for?

This guide is for every party importing, or planning to import, medical devices or IVD products into Türkiye. Manufacturer representatives and distributors are the group managing the communiqué scope and the ÜTS infrastructure most frequently. Hospital and laboratory procurement units look at this frame when questioning a supplier's import competence. Clinical research teams must know the rules that differentiate device imports for investigation. Customs brokers and logistics providers build the document chain before the declaration. Quality and regulatory units keep the product portfolio current at each annual communiqué renewal. E-commerce operations and healthcare institutions buying directly are also in scope: even where the end use is healthcare delivery, the import follows the commercial transaction rule. In an audit the question runs one way: through which permit and registration chain did this device enter the country.

Which products does it cover?

The scope is drawn by the GTİP list in the communiqué annex and approaches the entirety of products falling under the medical device definition: devices for diagnosis, treatment and monitoring, surgical instruments, electromedical equipment, imaging systems, IVD analysers and kits, dental products, active implantable devices, and their accessories and components. A device's software component passes through the same chain as part of the device. Borderline products, whether device or not, are in practice the subject of this article: wellness applications, general-purpose measuring devices and cosmetic devices sit at the definition's edge and should not be imported before the qualification decision is filed. On the GTİP side, the device family is gathered mainly under the mechanical and electromechanical medical instruments position; but each product is classified by its own composition and function. The communiqué annexes change annually; deciding from the previous year's list is the primary source of scope error.

When does it apply?

The communiqué control applies to every free circulation entry of products in scope, before the declaration. Some situations concentrate the risk. On first import the product has no ÜTS history, and the registration process moves ahead of the import calendar. When the device undergoes a model or version change, the ÜTS registration and conformity documents must be renewed; shipping a new product on an old record produces a mismatch. A change in the notified body certificate's scope or validity requires the evidence set's update. A manufacturing site change makes the CE certificate a matter of re-assessment. A change of authorised representative triggers rebuilding the registration chain from the start. Shipment of the same device under different GTİP codes requires the scope reading for every declaration. Used or refurbished equipment imports are a separate assessment subject and in most cases conflict with the placing-on-market rules. Temporary imports, for fairs, service or demos, must be clarified in status separately.

Legal framework and authority

The frame has three layers. The first is the medical device legislation: Türkiye applies the European Union device regulations nationally; the product's placing on the market, CE marking, notified body processes and registration obligations are set in that frame. The second is the registration and traceability system: ÜTS runs the device's national registration and traceability; registration operates as a precondition of placing on the market and of import. The third is the foreign-trade control: the annual product safety and inspection communiqués determine which products are inspected by which mechanism at import; for the 2026 period the relevant numbered communiqué of that family governs medical devices. The competent authorities are TİTCK and the Ministry of Trade: TİTCK manages the device legislation and the registration system, while the customs-side control runs through the Ministry's system. The communiqué text and annexes are published in the Official Gazette; announcements are tracked from the ministry's product safety unit. The current numbering can change every year; the current text must govern before every application.

Step-by-step process

1. Clarify the product's device definition and classification: which rule, which class, which conformity assessment route.
2. Confirm the GTİP from your classification file and check the scope against the current year's communiqué annex.
3. Verify the ÜTS registration: is the product registered model and version by version, is the record consistent with the importer information.
4. Collect the evidence set: CE declaration of conformity, notified body certificate, label and instructions for use samples, Turkish-language information requirements.
5. Bind the authorised representative and importer roles in writing; add the responsibility matrix to the file.
6. Create the TAREKS conformity application before the declaration, upload the documents and await the risk outcome.
7. Complete the customs flow on a no-control-needed outcome; if control is selected, prepare for the technical assessment.
8. Keep a file ready that can present the product-label-registration match quickly in a document review or physical inspection.
9. Archive the records after the shipment and update the scope table at the annual communiqué renewal.

Document checklist

• Device definition, classification rationale and the conformity assessment route applied.
• CE marking information and the signed declaration of conformity, matching the product version.
• Notified body certificate, its scope and validity verified.
• ÜTS registration output, with model and version matching.
• Authorised representative designation and importer details.
• Label and instructions for use samples, with the mandatory Turkish-language information.
• GTİP classification note and the current communiqué annex page.
• Purchase documents: proforma, invoice, consistency of the product description with the file.
• TAREKS application and outcome records.
• Shipment file: declaration, control outcome, receipt records.

Parties and responsibilities

The matrix binds the two ends of the registration chain together: the manufacturer's technical evidence and the importer's commercial declaration. Whichever end breaks, the result is the same: waiting at customs and nonconformity risk.

Exceptions and edge cases

The edges of communiqué practice need care. Bringing devices for research purposes does not count as placing on the market and is the subject of the clinical investigation legislation; but at customs the inspection route is still asked and the status must be shown with documents. Personal-use and passenger accompanying goods limits are assessed for consignments without commercial character; the boundary is quantity and genuine intended use. Equipment arriving temporarily for service and maintenance is assessed under temporary status rules and carries an exit obligation. At the device-software boundary, whether the software is offered with the device or independently changes the registration and declaration chain. In IVD products, the difference between diagnostic use and research use changes the status. A device's non-medical general-use equivalent is the subject of different legislation; the claim and intended use are decisive. For products entering the annexes of more than one communiqué, the most comprehensive assessment governs. Even for a product that appears out of scope, a screening record should be kept.

Common mistakes

The most common mistake is planning the shipment without ÜTS registration; the product waits at the port for the record. The second is taking the declaration of conformity from an outdated version; the product version and the document mismatch. The third is not verifying the notified body certificate's scope; the certificate exists but the product is outside its scope. The fourth is neglecting the mandatory Turkish-language information on the label; in a physical inspection it is direct nonconformity. The fifth is looking at last year's communiqué annex; the scope list has changed. The sixth is processing an investigation device like a commercial import; the status error requires retrospective correction. The seventh is not reflecting a distributor change into ÜTS; the registration chain breaks.

Important notice

This article is general information, not legal or customs advice; for a specific device's scope, registration and permit status, TİTCK legislation and the current communiqué texts must govern and a licensed customs broker consulted. GTİP codes and communiqué numbers mentioned here are illustrative; the GTİP examples are not binding, and the numbering can change annually. Official sources must be checked before any transaction.