Import Inspection of Medical Devices – Communiqué (Product Safety and Inspection): 2026/16 (Türkiye)

Scope

• Products: Those listed in Annex-1, identified by GTIP and product description (e.g., certain wound dressings and sterile surgical items, contact lens solutions, selected disinfectants classified as medical-device disinfectants, IVF-related culture media, various IVD reagents/test kits under defined conditions, examination gloves, condoms, specific dialysis-related items, selected imaging/diagnostic equipment and accessories, certain implant/prosthetic items, and other defined medical device categories).
• Regimes covered:
• Explicit exclusion: Goods returning under the Outward Processing regime.

Application and Review Process

• System: All import inspection procedures are conducted via TAREKS, based on risk analysis.
• Prerequisites: Importers must be defined in TAREKS and must have at least one authorized firm user (aligned with the general TAREKS framework Communiqué UGD: 2025/28).
• Timing: Controls are performed before customs declaration registration, under the Customs Regulation approach (Art. 181/4 reference logic).
• Risk analysis factors (as defined in the Communiqué): firm data in TAREKS, historical import inspection and market surveillance outcomes, manufacturer/importer and user information, customs entry point, product type/brand/model, price and quantity, origin/shipping/trade country, and other risk indicators.

Document workflow

• At application stage, the firm user submits the TAREKS application and uploads the documents listed in Annex-2 (items 1 and 2).
• If routed to physical inspection, additional documents under Annex-2 (items 3–5) must be uploaded within 20 working days (including the application day). Failure to upload within the deadline results in a negative outcome.
• Integrity rule: If the EU Declaration of Conformity, certificates, test reports, or other requested documents are found not to be issued by the relevant party, the inspection is concluded negatively, even if other conditions appear compliant.

Documents to Upload in TAREKS (Annex-2)

1. Relevant customs/transport documents depending on the goods’ status (summary declaration, transit/transport docs such as B/L–CMR–CIM, free zone forms, prior declarations for warehouse/temporary import, etc.; and when required, the customs declaration).
2. Invoice or proforma invoice.
3. EU Declaration of Conformity (and if drafted in another language, together with an approved Turkish translation).
4. Turkish label and instructions for use (IFU).
5. Product photos taken in the customs-controlled area.

Validity and Legal Effect

• If the inspection is concluded positively, a TAREKS reference number is issued and must be entered by the importer into Box 44 of the customs declaration.
• The TAREKS reference number is valid for 1 year from issuance.
• A positive TAREKS outcome or issuance of a reference number does not mean the product is proven fully compliant or safe; it only serves for the relevant import transaction and cannot be used as general proof of compliance.

Fixed reference numbers (special cases)

• For imports under the postal/express cargo rules referenced (Decision No. 2009/15481 framework – “Fifth Part”), TAREKS application is not made; instead, the fixed 23-digit TAREKS reference number 18160099116115014436576 is declared in Box 44.
• For returned goods (Customs Regulation Art. 446 scenarios), TAREKS application is not made; the fixed 23-digit TAREKS reference number 24160099916464780107088 is declared in Box 44.

Enforcement and Compliance Risk

• Importers remain responsible for ensuring products comply with the applicable medical device regulations and related obligations whether inspected or not, under Law No. 7223.
• Violations or misleading declarations may trigger enforcement under:
• In TAREKS-based inspections, a firm user’s authorization may be suspended (1–12 months), and the firm may be routed to systematic physical inspection for 1–12 months, depending on the nature and severity of the non-compliance and compliance history.

Repealed Regulation and Entry into Force

• Communiqué 2025/16 is repealed.
• Entry into force: 1 January 2026.
• Transitional provision: For shipments where the transport document was issued (or the goods were presented to customs under customs rules) before 1 January 2026, the import may—upon a TAREKS application and importer request—be finalized under the repealed Communiqué until 28 February 2026 (inclusive).

Compliance Assessment

From an importer’s compliance perspective, the practical risk areas are concentrated in three places:

1. Regulatory identity and documentation consistency: Medical device classification, declared product identity (brand/model), and the conformity documentation set (EU DoC + notified body certificates where required) must be consistent and traceable.
2. Turkish labeling/IFU readiness: Missing or non-compliant Turkish labeling/IFU is a frequent operational blocker and can create clearance delays and post-clearance enforcement exposure.
3. Bonded-area photo and deadline discipline: A weak internal process for collecting customs-area photos and uploading documents within the 20 working days window can turn a manageable case into a negative outcome and raise future risk scoring.

See the legislation document.