Importer Obligations under Madde 13 of the Turkish Medical Device Regulation

1. Key takeaways

The importer sits at the point where goods physically enter Turkey, and the regulation gives that role a duty of its own that cannot be delegated upward or sideways. This article sets out the core rule of Madde 13, explains why the duty is independent, and connects it to the importer’s role in the ÜTS system and to the parallel provision for IVDs.

• The rule in Madde 13 paragraph 1 is extremely plain yet extremely binding: importers may place on the market only devices that conform to this Regulation (the original Turkish text reads: İthalatçılar, yalnızca bu Yönetmeliğe uygun cihazları piyasaya arz ederler). There is no flexibility built into this sentence; conformity is the sole admission ticket for anything the importer releases.
• This obligation is an independent one. The importer cannot excuse itself from its own verification duty on the grounds that the upstream party provided the documents or that the authorised representative has already handled the matter. The person who signs off the release is always the importer, and responsibility follows that signature.
• The importer is one of the subjects of the obligations under Madde 34, and the ÜTS-side actions of declaring imports, stock and movement ultimately leave their trace in the system through the importer. The paper trail and the system trail must therefore both point back to the same party.
• The corresponding provision in the IVD Regulation is Madde 14 (importer obligations), which carries a different article number from the device regulation. Companies active in both categories must be careful to cite the correct article for each product line.

2. Legal basis

The duty described above is anchored in the importer provisions of the Medical Device Regulation, with a parallel article in the In Vitro Diagnostic Medical Devices Regulation published on the same day in the same gazette issue. The importer’s duty under paragraph 1 of Madde 13 is the entry rule for everything that follows, while Madde 34 carries the broader set of economic-operator obligations in which the importer participates. The table below records both instruments and the exact articles relied on in this article, so that any statement above can be traced back to its source provision.

3. Expert insights

Insight one: placing only conforming devices on the market is an obligation of result. The wording offers no buffer such as making reasonable efforts or acting in good faith. The consequence is direct: as soon as a device that has been placed on the market does not conform to the regulation, the importer is in a state of violation, regardless of what the importer did or believed beforehand. The rule is written at the level of the outcome, not of the effort, so diligence that stops short of actual conformity does not discharge the duty. This pushes importers to build their own market-access checks into day-to-day operations rather than relying entirely on the manufacturer’s assurances, because after the fact a good-faith belief will not undo the release, and the signature on the release remains the importer’s own.

Insight two: the importer stands at the junction of goods and compliance. Unlike the authorised representative, the importer deals directly with customs and warehousing. Where a product registration is missing on the ÜTS side or the Barkod information does not match, the goods can physically clear customs, yet they cannot circulate legally within the system. That contradiction between the physical world and the regulatory world usually surfaces only at the end-user stage or during a spot check, when it is most expensive to fix. Matching the physical release against the system status at the moment of release is therefore the practical way to keep the two worlds consistent.

Insight three: the importer and the authorised representative may be the same entity, but the obligations do not merge. The two roles originate from different provisions, Madde 11 and Madde 13 respectively, and each carries its own content. Even where a single company holds both roles, the two sets of duties should be listed separately in the internal documentation, which makes later audits straightforward and prevents one role from being silently absorbed into the other.

4. Practical recommendations

• When signing the agreement with the importer, define the pre-release checklist explicitly: validity of the CE certificate and coverage of the models, ÜTS product registration status, completeness of the language versions, and scannability of the UDI carrier. Writing the items down turns a vague duty into a testable procedure.
• Turn the checklist above into a per-shipment signature sheet, kept as evidence of performance of the duty under Madde 13 paragraph 1, so that every release can be traced back to a documented check.
• Define the actions and time limits for the importer’s ÜTS-side declarations of receipt into and issue out of stock, and incorporate them into a monthly reconciliation, so that system records and physical movements never diverge unnoticed.

5. Verification checklist

• □ The importer is aware of and has confirmed in writing the obligation under Madde 13 paragraph 1 to place only conforming devices on the market.
• □ A pre-release checklist has been established, and signed records are retained for each shipment.
• □ Responsibility and time limits for ÜTS-side import, stock-in and stock-out declarations have been assigned to named persons.
• □ Where the authorised representative and the importer are the same entity, the two sets of duties are listed separately.
• □ IVD business has been re-referenced to Madde 14 of the IVD Regulation.

Regulatory information verified as of 29 October 2026. The provisions cited in this article were checked against the current texts on the Turkish legislative information system (MevzuatNo 38657, 38658).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team coordinates authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com