Business Q&A

Yes. Medical devices must be registered in Türkiye's Product Tracking System (ÜTS) before they can be legally placed on the Turkish market, subject to applicable regulatory exemptions.

No. FDA approval, NMPA certification and other non-European regulatory approvals cannot replace the CE conformity requirements applicable in Türkiye. Medical devices generally require compliance with the EU Medical Device Regulation (MDR) or eligible MDD documentation covered by the applicable transitional provisions.

The registration process typically takes approximately 2–4 weeks, provided that all required documents are complete, accurate and properly submitted. This is an indicative timeframe and may vary depending on the product and regulatory requirements.

Not directly without an appropriate local legal presence or registration arrangement. A foreign manufacturer may establish a company in Türkiye and manage the registration process through that entity, provided the applicable regulatory and authorization requirements are met.

Your medical device registration generally remains valid as long as the relevant quality and conformity certificates remain valid and all required registration updates are properly maintained.

Foreign manufacturers can generally work with a qualified local distributor or an eligible third-party regulatory service provider.

Our perspective: Working with a reliable distributor is usually the more practical approach. It simplifies regulatory coordination, commercial operations and ongoing market management. Independent registration service providers can also be used, but separating regulatory responsibilities from commercial activities may create additional operational challenges.

No. Medical device registration and reimbursement are separate processes. Registration alone does not grant reimbursement eligibility. Where applicable, reimbursement applications must be submitted and evaluated separately after the necessary registration procedures have been completed.

DMO (Devlet Malzeme Ofisi), Türkiye's State Supply Office, is a government organization responsible for centralized public procurement. In the medical device sector, DMO provides a procurement platform through which eligible public healthcare institutions can purchase registered and listed medical devices. For manufacturers and distributors, DMO listing represents an important channel for accessing the Turkish public healthcare market. However, medical device registration alone does not automatically qualify a product for DMO listing.

No. Not all medical devices are included in Türkiye's reimbursement system. Obtaining reimbursement coverage for a new medical device or innovative technology can be a lengthy and complex process that requires specialized regulatory knowledge, market access expertise, and careful planning.

For a medical device that is already eligible for reimbursement, the estimated timeline is as follows, provided that all required documentation is complete and properly submitted:

• Medical Device Registration (ÜTS): 2–4 weeks
• Reimbursement Application: 4–8 months
• DMO Listing: 6–12 months

These are indicative timelines based on practical market experience. Actual processing times may vary depending on the product category, regulatory requirements, and administrative procedures.

DMO listing involves additional requirements beyond medical device registration and, where applicable, reimbursement procedures. Depending on the procurement category and applicable requirements, additional qualification or compliance approvals and reference sales invoices may be necessary.

There are generally two options:

1. Authorization by the existing distributor: Your current distributor authorizes your new distributor to operate under the existing product registration.
2. New registration and reimbursement procedures: Your new distributor must complete both the product registration and applicable reimbursement procedures from the beginning.

The appropriate approach depends on the cooperation between the parties and the applicable regulatory requirements.

Any changes to your registration documents should be promptly communicated to your distributor in Türkiye. The relevant product registration records must be updated accordingly without delay to maintain regulatory compliance.