Lupos Dış Ticaret
Importing medical products or "tıbbi cihaz" from China into Turkey is a high-stakes process that goes far beyond logistics. Missing documentation, misclassified GTIP codes, or incomplete CE compliance can result in shipment seizure, fines, or regulatory rejection. For SMEs and procurement teams, risk management and compliance must take priority over speed and price. This requires structured import consulting from China to Turkey. At Lupos Dış Ticaret, we operate as your accountable partner, ensuring that every shipment meets Turkish Import Regime and Ministry of Health requirements.
Medikal ve Sağlık Ürünleri İthalatı
This category includes medical consumables, health supplements, and non-device healthcare products. While these may appear less complex than medical devices, Turkish customs treats all medical imports with scrutiny. Correct classification, documentation, and compliance are critical.
General Process and Regulatory Requirements
Before products leave China, verify the manufacturer’s credentials. A "gold supplier" badge on Alibaba is not sufficient. Factories must hold authentic ISO 13485 certification, demonstrate sustainable quality systems, and, for certain products, obtain authorization from the Ministry of Health or Ministry of Agriculture. This verification should be conducted through structured factory inspection in China.
- Supplier Verification: Confirm factory export license, ISO certificates, and testing laboratory authenticity.
- Product Licensing: Identify if special permits are required for the Turkish market.
- Technical Documentation: Prepare Turkish-language labels and instructions; professional technical translation is often required.
Pre-import checks reduce the risk of customs delays, rejections, or fines.
Taxation and Customs Rules
Beyond Value Added Tax (KDV) and Customs Duty, some medical products may be subject to additional surveillance (Gözetim) or supplementary customs obligations (İlave Gümrük Vergisi). Correct GTIP assignment safeguards both your investment and compliance.
- Verify GTIP codes for accurate customs declaration.
- Calculate KDV and applicable import duties precisely.
- Prepare documents for risk-controlled products subject to TAREKS inspection.
Medical Device Importation (Tıbbi Cihaz İthalatı)
Medical devices are the most heavily regulated category. Turkey has aligned closely with EU standards through MDR and IVDR, making CE compliance, ÜTS registration, and TAREKS notifications mandatory for all device imports.
GTIP Classification and CE Compliance
Correct GTIP assignment determines whether a TAREKS application or ÜTS registration is required. CE marking is mandatory, but a sticker alone is insufficient. Verification of the Notified Body (NB) number and Declaration of Conformity is critical.
- Identify device class (Class I, IIa, IIb, III) per intended use.
- Ensure CE marking is valid and supported by a Declaration of Conformity.
- Confirm manufacturer compliance with ISO 13485 quality standards.
TAREKS and ÜTS Registration
Compliance failures at TAREKS or ÜTS are the leading cause of shipment rejection in Turkey. Both systems are mandatory for medical devices.
- Company Registration: Importer must be registered in ÜTS.
- Product Registration: Each device must have a unique registration before customs clearance.
- TAREKS Inspections: Products are subject to risk analysis and potential physical inspection (Fiili Denetim). Documentation must be complete and accurate to pass.
Technical Documentation Requirements
Technical files must include detailed specifications, Turkish usage instructions, labeling, and, for certain devices, clinical evaluation reports. Proper documentation ensures approval during customs inspections and Ministry audits.
Risk Management and Operational Oversight
Many SMEs lose substantial funds due to trusting sourcing agents or freight forwarders unfamiliar with Turkish medical regulations. A freight forwarder moves boxes; an accountable operator like Lupos Dış Ticaret manages legal compliance.
Avoiding Fraud and Supplier Risks
We prioritize supplier verification and fraud prevention. Factory licenses, product certificates, and test reports are cross-checked with international standards to prevent costly mistakes.
- Audit supplier export licenses against Proforma Invoice items.
- Verify laboratory credentials issuing test reports.
- Perform pre-compliance checks before shipment leaves China.
Frequently Asked Questions (FAQ)
Can I import medical devices without an ÜTS registration?
No. ÜTS registration is mandatory for customs clearance for any medical device under Turkish regulations (2025/16 and 2026/16 Product Safety and Inspection Communiqués).
How has the MDR transition affected imports from China?
The shift from MDD to MDR increased documentation requirements. Older Chinese certifications may no longer be valid. Suppliers must update technical files to comply with EU-aligned standards.
What happens if TAREKS rejects my application?
Rejection may result in goods being returned to China or destroyed at the importer's expense. Pre-compliance verification is crucial to avoid such outcomes.
Is a CE certificate from a Chinese lab sufficient?
Only if issued by a recognized Notified Body authorized for the specific device class. Many Chinese certificates are unofficial test reports and will be rejected by Turkish Customs.
Are there exemptions for certain health products?
Low-risk consumables or non-device medical products may be exempt from TAREKS or ÜTS registration. Confirm requirements per GTIP and Ministry guidelines.
Ensure compliance, prevent risk, and protect your investment. Let Lupos Dış Ticaret manage your medical and health product imports from China to Turkey with full accountability and operational oversight. To structure your import project correctly, contact our import consulting team.
