Do you need an import licence for medical devices in Turkey? Usually, there is no single blanket “medical device import licence” that replaces every regulatory step. The correct path is layered: first confirm that the product is a medical device or IVD, then determine its risk class and conformity route, identify the manufacturer/importer/authorised-representative roles, complete the applicable ÜTS records, check whether the product/GTİP falls within the 2026/16 import-control scope, and separately confirm any sales-centre or distribution authorisation that applies.
For foreign manufacturers and importers, the practical sequence is therefore classification → conformity → economic-operator roles → ÜTS → 2026/16/TAREKS → customs → sales/distribution readiness. Treating any one of these layers as the entire “licence” creates avoidable border and market-access risk.
Quick Answer: Is There One Medical Device Import Licence?
No. Turkey’s medical-device market-access framework is built from several distinct legal and operational gates. A CE mark or ÜTS registration does not automatically replace customs/import controls; a TAREKS result does not replace product conformity; company incorporation does not itself authorise regulated medical-device sales.
| Layer |
Main question |
What it does not replace |
| Product scope & classification |
Is the product a medical device/IVD and what risk class applies? |
Conformity assessment, ÜTS, import control or sales authorisation. |
| Conformity / CE |
Does the device meet the applicable Turkish MDR/IVDR requirements? |
ÜTS registration, TAREKS or customs clearance. |
| Economic-operator setup |
Who is manufacturer, authorised representative, importer and distributor? |
Product registration or customs declaration. |
| ÜTS |
Are the relevant firm/device records and traceability data in place? |
Conformity assessment or import inspection. |
| 2026/16 + TAREKS |
Is the product/GTİP in scope for import product-safety control? |
General customs formalities or market-placement obligations. |
| Sales/distribution authorisation |
Does the planned commercial activity require a Medical Device Sales Center authorisation or qualified staff? |
Company formation, conformity or customs compliance. |
Medical-device market access in Turkey is a layered regulatory process rather than one universal import-licence application.
1. Confirm That the Product Is Actually a Medical Device or IVD
The first decision is product scope and intended purpose. Medical devices and in vitro diagnostic medical devices are governed by separate but related Turkish regulations aligned with the EU MDR/IVDR framework. Classification must be based on the product’s intended purpose, design and applicable classification rules—not on the commercial description used by the seller.
If the product is incorrectly classified at this stage, every later step can be wrong: conformity documentation, notified-body involvement, ÜTS records, import-control scope, labelling and sales requirements.
2. Risk Class Determines the Conformity Route
Do not assume that every medical device requires a notified-body certificate. The applicable conformity route depends on the device or IVD class and specific characteristics.
- Certain lower-risk devices, such as qualifying Class I devices and qualifying Class A IVDs, can follow manufacturer self-declaration routes when the regulation allows it and the required technical documentation is complete.
- Higher-risk devices and devices with characteristics that trigger third-party assessment require the applicable notified-body conformity route.
The practical rule is simple: establish the classification first, then identify the exact conformity-assessment annex and evidence that applies. A generic checklist that demands a notified-body certificate for every product is not reliable.
3. What the Pre-Shipment Conformity File Should Prove
The conformity file should be internally consistent across the manufacturer, device model, intended purpose, classification and certificates. Depending on the device and route, the file can include:
- EU/Turkish Declaration of Conformity;
- CE marking evidence;
- notified-body certificate where the applicable conformity route requires one;
- technical documentation required by the MDR/IVDR;
- risk-management, clinical/performance and post-market documentation as applicable;
- UDI and device-identification data where required;
- labelling and instructions for use in the language/form required for the Turkish market;
- manufacturer and economic-operator information that matches the regulatory records.
ISO 13485 should not be treated as a universal import permit. Quality-management-system obligations and certification evidence depend on the manufacturer’s applicable regulatory/conformity route. The key question is whether the manufacturer meets the QMS obligations that actually apply to the device, not whether an importer has collected one generic “ISO document.”
4. Manufacturer, Authorised Representative, Importer and Distributor Are Different Roles
One of the most common errors is collapsing every local party into a single “Turkish representative/importer” role. Under the medical-device framework, these functions have different legal responsibilities.
| Role |
Core function |
Key control |
| Manufacturer |
Places the device on the market under its name/trademark and carries the manufacturer obligations. |
Correct manufacturer identity and conformity responsibility. |
| Authorised Representative (AR) |
Acts under a written mandate for the manufacturer where Article 11 requires/permits the role. |
Do not assume every foreign manufacturer needs a Turkish AR. |
| Importer |
Places a device from a third country on the Turkish market and has importer verification obligations. |
Importer identity and pre-market verification must align with the product records. |
| Distributor |
Makes the device available further in the supply chain. |
Storage, traceability and verification obligations can apply. |
When Is a Turkish Authorised Representative Required?
Article 11 of the current Medical Device Regulation does not support the statement that every foreign manufacturer must appoint a Turkish authorised representative. The relevant test is whether the manufacturer is established in Turkey or an EU Member State. Where the manufacturer is established in neither, the authorised-representative requirement applies under the regulation.
This distinction matters for manufacturers in the United States, United Kingdom, China and other non-EU jurisdictions, but should not be mechanically imposed on an EU-established manufacturer.
5. ÜTS: Product and Economic-Operator Registration / Traceability
The Ürün Takip Sistemi (ÜTS) is Turkey’s national product-tracking system for medical devices and related regulated products. It is a major market-access and traceability layer, but it should not be described as a substitute for CE/conformity assessment or customs/TAREKS.
Before shipment or market placement, verify the exact ÜTS requirements for the economic operators and device concerned. Relevant firm, device, UDI and transaction records must be consistent with the regulatory file and the role each company actually performs.
A useful operational check is to compare the following across all records:
- manufacturer legal name and address;
- authorised representative where applicable;
- importer/distributor identity;
- device family/model and UDI information;
- Declaration of Conformity and notified-body details where applicable;
- labelling/IFU and product identifiers.
6. 2026/16 and TAREKS: The Import-Control Layer
For 2026, medical-device import controls are governed by the Medical Devices Import Inspection Communiqué (Product Safety and Inspection: 2026/16) for the products listed within its scope. The correct import analysis therefore starts with the exact product and GTİP, not simply the words “medical device.”
The Ministry of Trade uses TAREKS, its web-based risk-based control system, for relevant import/export product-safety inspections. TAREKS is specifically designed so that not every shipment is physically inspected in the same way; risk criteria determine which transactions require further control.
Important 2026 point: the Ministry announced that medical devices imported under the Temporary Import Regime were also brought within the inspection scope under the 2026 changes.
Pre-Shipment TAREKS / Customs Questions
- What is the exact GTİP of the product?
- Is that GTİP/product description within the annex/scope of 2026/16?
- Are the manufacturer, importer and device records consistent with the conformity and ÜTS records?
- What documents/data does the current TAREKS route require for this transaction?
- Has a licensed customs professional reviewed the customs declaration and product-safety handoff?
For the broader customs process, see Customs Clearance Steps in Turkey: 2026 Importer Guide.
7. CE Does Not Automatically Mean Customs Release
A valid CE marking and conformity file are fundamental, but they do not mean that every import transaction will automatically clear. Customs and TAREKS controls look at the actual shipment, declared product, GTİP, documents and applicable import-control rules.
Likewise, a positive import-control result does not erase ongoing manufacturer/importer/distributor obligations under the medical-device rules.
8. Sales and Distribution Can Require a Separate Authorisation Layer
After product conformity and import readiness, ask a separate commercial question: how will the device be sold and distributed in Turkey?
The Medical Device Sales, Advertising and Promotion Regulation contains a separate Medical Device Sales Center authorisation framework and personnel/working-document rules for activities within its scope. Do not assume that every importer follows exactly the same sales-centre route, but do not assume that company incorporation or ÜTS alone authorises every sales activity either.
Before launch, map the planned activity—import only, wholesale distribution, direct sales, retail, tender supply, after-sales/service—and confirm the authorisation/personnel requirements that apply.
9. Company Formation Is Only One Layer
A Turkish company can support the market-entry structure, but regulatory product approval and customs readiness remain separate workstreams.
A Turkish company may be part of the importer/distributor structure, but incorporation does not itself authorise medical-device market placement. If a foreign investor needs a Turkish operating entity, company formation should be coordinated with the regulatory role map so the company purpose, importer/distributor role, premises and responsible personnel are designed consistently.
For the entity setup process, see Company Registration in Turkey: MERSIS & Filing Guide.
10. Go / Fix / Stop Checklist Before Shipment
| Status |
Question |
Action |
| GO |
Product scope/class, conformity route, economic-operator roles, ÜTS status, GTİP/2026/16 and sales model are all aligned. |
Proceed to transaction-specific TAREKS/customs execution with the responsible professionals. |
| FIX |
Documents are mostly present but manufacturer names, UDI/model references, certificates, labels or ÜTS records do not match. |
Correct the inconsistency before shipment. |
| STOP |
Device classification is unclear, AR/importer role is wrong, conformity evidence is missing, or 2026/16 scope has not been checked. |
Do not ship on the assumption that customs can “fix it later.” Resolve the regulatory question first. |
11. Common Failure Points
- Treating “import licence” as one approval. The process is layered.
- Assuming every device needs a notified-body certificate. Conformity route depends on classification and device characteristics.
- Using ISO 13485 as a substitute for product conformity.
- Appointing a Turkish AR without checking the Article 11 Turkey/EU establishment test.
- Collapsing AR, importer and distributor into one legal role.
- Assuming ÜTS registration alone proves customs eligibility.
- Assuming CE alone guarantees TAREKS/customs release.
- Shipping before the exact GTİP and 2026/16 scope are confirmed.
- Ignoring the separate Medical Device Sales Center layer where it applies.
- Planning around fixed 2–4 week or 3–6 month promises. Timing can depend on classification, conformity route, notified-body involvement, record quality, TİTCK/ÜTS review, TAREKS selection and customs facts.
12. Post-Market Compliance Continues After Import
Medical-device compliance does not end at customs release. Manufacturer, authorised representative, importer and distributor obligations can continue through traceability, post-market surveillance, vigilance, corrective actions, recalls and record updates under the applicable MDR/IVDR framework.
If the manufacturer, device, intended purpose, labelling, certificate or other regulated data changes, determine whether the conformity and ÜTS records must be updated before continuing supply.
13. How Workon Can Support a Medical-Device Market Entry
Workon can coordinate the business-setup and market-entry workstream: Turkish company formation where needed, registered-address/workspace planning, document coordination and project management between the investor and the appropriate regulatory/customs specialists.
Workon coordinates the business-setup and market-entry workstream and can align the project with appropriately qualified medical-device regulatory specialists and licensed customs professionals. Technical conformity decisions remain with the competent regulatory specialists/notified bodies as applicable, customs declarations and brokerage remain with licensed customs professionals, and TİTCK and the Ministry of Trade retain their authority over regulatory and import-control decisions.
For transaction-level customs-readiness coordination around the shipment, see Workon’s Customs Process Coordination in Turkey.
Key Takeaways
- There is no single blanket medical-device import licence that replaces every compliance layer.
- Product classification and intended purpose come first.
- Notified-body involvement is risk/route-specific; it is not universal for every device.
- A Turkish authorised representative is not automatically required for every foreign manufacturer; the Turkey/EU establishment test matters.
- ÜTS, CE/conformity, TAREKS and sales-centre authorisation are separate gates.
- Medical devices within the relevant 2026/16 scope are handled through the 2026 import product-safety framework; exact GTİP/product scope must be checked.
- TAREKS is risk-based; not every shipment follows identical physical inspection handling.
- Do not plan around unsupported fixed approval or customs-release timelines.
No. Medical-device market entry is layered. Product classification and conformity, the manufacturer\/importer\/authorised-representative roles, ÜTS records, any applicable 2026\/16 TAREKS import control, customs formalities and sales\/distribution authorisation must be assessed separately.
No. The conformity route depends on the device or IVD classification and characteristics. Certain lower-risk devices can follow an eligible manufacturer self-declaration route, while higher-risk or otherwise specified devices require the applicable notified-body assessment.
No. Under the current medical-device framework, the relevant establishment test includes Turkey and EU Member States. Where the manufacturer is established in neither, the authorised-representative requirement applies under the applicable regulation; the actual manufacturer and product route should be checked before appointment.
No. ÜTS is an important registration and traceability layer, but it does not replace product conformity, TAREKS or customs controls. The shipment, GTİP, economic-operator data and applicable import-control rules must also be consistent.
No. CE and conformity evidence are fundamental, but customs and TAREKS assess the actual shipment, declared product, GTİP, documents and applicable import-control rules. A positive import-control result also does not remove ongoing medical-device obligations.
Confirm the product scope and class, exact conformity route, manufacturer and local economic-operator roles, ÜTS status, 12-digit GTİP, whether 2026\/16 and TAREKS apply, the customs document pack and any separate Medical Device Sales Center or qualified-personnel requirement before dispatch.
Important: This guide provides general regulatory and market-entry information and is not medical-device regulatory, customs or legal advice. Classification, conformity assessment, authorised-representative requirements, ÜTS records, 2026/16/TAREKS controls, customs treatment and sales-authorisation requirements are product- and transaction-specific and can change. Before shipment or market placement, verify the current TİTCK and Ministry of Trade rules with qualified medical-device regulatory professionals and, for customs declarations, an appropriately licensed customs professional. Workon coordinates business setup and market-entry readiness but does not grant or guarantee regulatory or customs approval.
