A medical device manufactured outside Türkiye and outside the EU cannot reach the Turkish market on its own. Article 11/1 of the Medical Device Regulation, published in the Official Gazette of 2 June 2021 (No. 31499, repeated issue), is categorical: where the manufacturer is not established in Türkiye or in an EU member state, the device may be placed on the market only on condition that the manufacturer appoints an authorised representative. Article 11/5 explains why that is a legal decision rather than an administrative one — where the manufacturer has failed to comply with Article 10, the authorised representative is legally liable for defective devices on the same basis as the manufacturer, jointly and severally.
Everything else follows: who signs the mandate, what it says, who imports, whose name goes on the box, and who is left holding the file when a device fails.
Placing a Medical Device on the Market: Three Roles, Three Statutes
Turkish device law is built in two layers. The framework layer is Product Safety and Technical Regulations Law No. 7223, which defines placing on the market in Art. 3/1(k) as making a product available for the first time and sets out each operator’s duties in Arts. 7 to 10 alongside the product liability regime in Art. 6. The sectoral layer is the Medical Device Regulation, which repeats those roles with device-specific content and adds registration, unique device identification and post-market surveillance. One divergence between them matters commercially. Law No. 7223 defines the authorised representative in Art. 3/1(t) as a person established in Türkiye; the Regulation, in Art. 3/1(lll), defines the same role as a person established in Türkiye or in an EU member state. The importer is defined without ambiguity in Art. 3/1(y) of the Regulation as a person established in Türkiye placing a device from a third country on the Turkish market. Where a group already runs an EU authorised representative and would rather not duplicate it, that is the first question to settle — not the last, and not after the distribution agreement has been signed.
| Role | Must be established in | Core statutory duty | Principal exposure |
|---|---|---|---|
| Manufacturer | Anywhere; if outside Türkiye/EU, must appoint a representative (Art. 11/1) | Design, risk management, clinical evaluation, technical documentation, declaration of conformity, post-market surveillance (Art. 10) | Product liability under Law 7223 Art. 6; recall and corrective action |
| Authorised representative | Türkiye or EU member state (Art. 3/1(lll)); Türkiye under Law 7223 Art. 3/1(t) | The Art. 11/3 minimum task list, which the mandate cannot cut below | Joint and several liability with the manufacturer for defective devices (Art. 11/5) |
| Importer | Türkiye (Art. 3/1(y)) | Verification before placing on the market (Art. 13/2); own identification on the device (Art. 13/3) | Product liability with the manufacturer (Law 7223 Art. 6/1); customs debt as declarant (Law 4458 Art. 181/2) |
| Distributor | No establishment rule | Verification before making available (Art. 14/2) | Deemed manufacturer if it rebrands or modifies (Law 7223 Art. 11/1; Art. 16/1) |
The Authorised Representative Mandate Is the Liability Instrument
The authorised representative agreement is where a device file is either built properly or quietly mispriced. Four provisions govern its content.
It must be written and accepted. Under Art. 11/2 the appointment becomes valid when a mandate is issued and accepted in writing by the representative, and it must cover at least all devices of the same generic device group. Art. 8/1 of Law No. 7223 adds that the manufacturer must define the nature, conditions and limits of the delegated powers clearly and in writing.
It has a floor the parties cannot go below. Art. 11/3 lists minimum tasks the mandate must require: verifying that the declaration of conformity and technical documentation exist and keeping copies available for the Agency; complying with the Art. 31 registration obligations; supplying, at the Agency’s request, all information and documents needed to demonstrate a device’s conformity in Turkish and/or an EU official language the Agency considers appropriate, and forwarding sample requests to the manufacturer; cooperating on corrective action and passing on complaints and reports of suspected incidents without delay; and terminating the mandate if the manufacturer acts contrary to its obligations. Law No. 7223, Art. 8/2 makes part of that floor statutory rather than contractual: even if the mandate is silent, the representative retains the documents for the prescribed period, supplies them on request, and carries out the authority’s instructions in risk-elimination activities without delay.
It has a ceiling. Art. 11/4 provides that the manufacturer may not delegate the obligations in Art. 10 paragraphs 1, 2, 3, 4, 6, 7, 9, 10, 11 and 12 — design and manufacture, risk management, clinical evaluation, technical documentation, the declaration and CE marking, the quality management system, post-market surveillance and corrective action. A mandate drafted as though the representative “takes over regulatory responsibility” describes something the Regulation does not permit.
It carries joint liability. Art. 11/5, again: where the manufacturer fails to comply with Art. 10, the representative answers for defective devices on the same legal basis, jointly and severally. A Turkish company asked to act as authorised representative is being asked to underwrite a manufacturer it does not control — which makes the negotiation one about indemnities, insurance and audit rights. Art. 10/16 is the point of leverage: manufacturers must have measures in place providing sufficient financial coverage for their potential liability, proportionate to risk class, device type and the size of the enterprise.
Art. 15/6 adds that the representative must have permanently and continuously at its disposal at least one person responsible for regulatory compliance. And Art. 12 requires a change of representative to be governed by a contract between the manufacturer, the incoming representative and, where applicable, the outgoing one, fixing at minimum the termination and start dates, the last date the outgoing representative may appear in promotional material, the transfer of documents, and its continuing duty to pass on complaints received after the mandate ends. Drafting the exit alongside the entry is what the text requires — the same instinct that applies when a Turkish distribution relationship ends, as set out in our note on terminating a distribution or agency agreement in Türkiye.
Registration: The SRN, the Device Record and ÜTS
Registration runs on tracks that commercial correspondence tends to collapse into one.
The operator track is Art. 31. Before placing a device other than a custom-made device on the market, manufacturers, authorised representatives and importers not already registered enter the Annex VI Part A data into the electronic system described in Art. 30; where a notified body is involved, that entry must happen before the application to it. The Agency verifies the data and communicates the single registration number (SRN) under Art. 31/2, and Art. 30/2 gives the importer two weeks from placing on the market to confirm the entry, report missing or incorrect data, and add its own details.
Then the clock keeps running. Art. 31/4 requires updates within one week of any change; Art. 31/5 requires the data to be confirmed within one year of submission and every two years thereafter, and lets the Agency take corrective measures if that has not been done within six months of those deadlines. Art. 31/7 makes the entered data public: a registration is a maintained record, not a certificate. The device track is Art. 29, under which the manufacturer assigns a Basic UDI-DI before placing the device on the market and enters it into the UDI database.
ÜTS sits on top of both. Art. 34/1 provides that, without prejudice to the EUDAMED obligations, economic operators established domestically, notified bodies, health institutions and health professionals fulfil their obligations relating to the national product tracking system — and Art. 34/2 leaves the content of those obligations to arrangements published by the Agency. The detailed ÜTS requirements are therefore not in the Regulation; they move by guidance, and because Art. 34/1 attaches them to domestically established operators they fall in practice on the Turkish importer or the Turkish-established representative. That is a drafting point about cost and cooperation, not a formality.
Where Importer Liability Actually Bites
The Turkish importer occupies four overlapping positions.
Regulatory. Art. 13/2(a) requires the importer, before placing a device on the market, to verify the CE marking and the declaration of conformity, that the manufacturer is identified and has appointed an authorised representative in accordance with Art. 11, that the device is labelled and accompanied by the required instructions, and that a UDI has been assigned where required. Art. 13/3 requires the importer’s own name and registered place of business on the device or its packaging without covering the manufacturer’s label; Art. 13/6 requires a register of complaints, non-conforming devices, recalls and withdrawals; and under Law No. 7223, Art. 9/1(e), the instructions and safety rules must be in Turkish.
Customs. Under Customs Law No. 4458, Art. 181/1(a), the customs obligation begins when the declaration for release into free circulation is registered, and Art. 181/2 makes the declarant the debtor — adding that in indirect representation the person on whose account the declaration is made is also a debtor, while the representative’s own liability is limited to cases where it knew, or customarily should have known in the exercise of its profession, that the data were incorrect. Classification and valuation therefore sit on the importer’s side of the ledger; the general framework is in our guide to importing goods into Türkiye.
Border inspection. The Medical Devices Import Inspection Communiqué (Product Safety and Inspection: 2026/16), Official Gazette of 31 December 2025 (No. 33124, fourth repeated issue), routes device imports through the risk-based TAREKS system: the inspection happens before the customs declaration is registered (Art. 5/1), and the reference number goes in box 44 and is valid for one year (Art. 11). Devices declared as covered by an A.TR movement certificate receive the number directly under Art. 6/1 — but Art. 6/4 allows risk analysis to route them to physical inspection anyway, so an A.TR is a probability, not an exemption. Once an application is routed to physical inspection, Art. 9/1 gives twenty working days including the day of application to upload the documents listed in Annex 2 — the system grants additional time if it is requested in TAREKS, and the application fails if the documents are not uploaded in time. That is a short window when the master file sits outside Türkiye and needs translating. Art. 12/2 then closes the most common misconception: permission to import, or a TAREKS reference number, does not mean the product is compliant or safe, and Art. 12/1 keeps the importer responsible under Law No. 7223 for what it imports, inspected or not.
Civil. Art. 6/1 of Law No. 7223 makes the manufacturer or the importer liable to make good damage caused by a product to a person or property. The claimant proves the loss and the causal link (Art. 6/2); multiple liable operators are jointly and severally liable (Art. 6/3); contract terms excluding or reducing that liability are void (Art. 6/4); and the limitation period is three years from knowledge of the damage and the person liable, and ten years in any event from the date the damage arose (Art. 6/6). A distribution agreement that purports to move product liability away from the Turkish importer does not do so as against the injured patient; it allocates recourse between the parties, which must be drafted as such. These claims sit where product regulation meets clinical practice, alongside our other health law work. The reach of that nullity — what survives it, and why an indemnity between the parties is not the same thing as a limitation against the injured person — is examined in why a contractual limitation of product liability is void.
When the Distributor Becomes the Manufacturer
Private labelling silently changes the parties’ legal identity. Art. 11/1 of Law No. 7223 states that importers and distributors placing a product on the market under their own name or trade mark, or modifying a product already on the market in a way that affects its conformity, are deemed manufacturers and must perform the manufacturer’s Art. 7 obligations. Art. 16/1 of the Regulation says the same for devices, with three triggers: own name or trade mark; changing the intended purpose; and modifying the device in a way that may affect compliance.
The Regulation, unlike the Law, writes in a narrow exception. Art. 16/1(a) carves out the case where the distributor or importer concludes a contract with the manufacturer under which the manufacturer continues to be identified as manufacturer on the label and remains responsible for meeting the requirements imposed on manufacturers. That contract is the whole of the exception. Without it, the Turkish party has assumed the technical documentation, the quality management system, post-market surveillance and vigilance reporting for a device it did not design.
Relabelling and repackaging are treated more leniently but not freely. Art. 16/2 says that supplying the manufacturer’s information, including translation, and changing the outer packaging are not modifications affecting conformity, provided the original condition is not affected; for sterile devices, opening or damaging the packaging that maintains sterility is presumed to affect it. The operator must state its own name and address together with the activity performed (Art. 16/3), must have a quality management system covering those procedures (Art. 16/4), and — the provision most often missed — must inform the manufacturer and the Agency at least 28 days before making the device available, giving the Agency a notified body certificate for that system within the same period (Art. 16/5).
There is also a trap for the distributor that simply stays quiet. Under Art. 11/2 of Law No. 7223, a distributor that fails to identify the manufacturer, authorised representative or importer — or, failing that, the previous operator in the supply chain — within ten working days of the authority’s notification is itself deemed the manufacturer, and Art. 11/3 applies the same rule, with the same consequence for damages, to a request from an injured party.
Selling the Medical Device Once It Is on the Market
Placing a device on the market and selling it are separate permissions. Under the Medical Device Sales, Advertising and Promotion Regulation (Official Gazette of 15 May 2014, No. 29001), sales run through a sales centre authorised by the provincial health directorate: Art. 26/1 prohibits sales by unauthorised persons, and Art. 26/2 prohibits authorised sales centres from selling devices that are not registered in the Agency’s system.
Two further provisions belong in the commercial negotiation. Art. 25/A obliges the sales centre that is the manufacturer or importer of the device to issue a warranty certificate for devices used in health service delivery that require technical service — which is one more reason the Turkish party’s role map matters, since the duty attaches to whoever holds that status here — with the burden of proving delivery on the sales centre, and Art. 25/B(2) sets the minimum term at two years. This is a device-specific regime; the warranty and after-sales documents an importer owes under Consumer Protection Law No. 6502 sit in a separate statute and are set out in our note on the importer’s two certificates. Art. 26/8 provides that, in the application of administrative sanction decisions taken under that Regulation or Law No. 7223, all sales centres that placed the product on the market and made it available are jointly and severally liable — which is why the indemnity clause between manufacturer, importer and reseller is not boilerplate. The exemption in Art. 33/2 is worth reading to the end: outlets selling the devices listed in Annex 3 need no authorisation — except the manufacturer or importer of those devices.
What the Contracts Have to Carry
Once the statutory map is settled, the drafting reduces to allocations the legislation leaves to the parties: whether the mandate’s scope covers the generic device group being sold; whether the authorised representative and the importer are the same Turkish company, which concentrates Art. 11/5 joint liability and Art. 6/1 product liability in one balance sheet; who bears the cost of registration maintenance and who funds a recall; what audit rights the representative has over a manufacturer whose defaults it will answer for; and what happens at the end, under the Art. 12 transfer contract. Customs classification and valuation belong in the same file, since a device that clears the border on a contested classification is a regulatory problem before it is a duty problem; that side of the work is described under import and export.
The recurring error in Turkish device files is not a missing form — it is a contract that treats the Turkish party as a logistics counterparty when the legislation has already made it a co-obligor.
This article describes the legislation in force on its date of publication. The administrative fine bands in Law No. 7223, Art. 20 are revalued annually by a Ministry of Trade communiqué, and the ÜTS obligations under Art. 34 of the Medical Device Regulation are set by Agency guidance; both should be checked in their current version before any decision is taken.
