Understanding Apostille Obligations for Medical Device Registration in Turkey

Market Entry into Turkey and the Reality of ÜTS Compliance

If you manufacture medical devices in China or Hong Kong and are planning to enter the Turkish market, you are targeting one of the most significant healthcare markets in the region. Turkey offers large-scale public procurement, a strong private healthcare sector, and long-term commercial potential. However, there is an important reality that must be addressed upfront: Turkey applies medical device regulations with a level of rigor that often exceeds that of the European Union.

This strict approach becomes most apparent during registration in Turkey’s Product Tracking System (ÜTS). One of the most common reasons for delays, rejections, or repeated deficiency notices is a misunderstanding of apostille requirements. Many manufacturers underestimate which documents must be apostilled and at what stage. This article clarifies the apostille obligations under the ÜTS framework, with a particular focus on the Declaration of Conformity and the EC Certificate.

EU-Aligned Framework with Stricter Enforcement

Although Turkey is not a member of the European Union, its medical device framework is fully aligned with MDR and IVDR. More importantly, these regulations are not treated as theoretical guidelines. They are actively enforced through administrative review, document verification, and post-market surveillance.

For a medical device to remain legally on the Turkish market, technical compliance alone is insufficient. Authorities also require legal certainty and documentary traceability. Apostille plays a central role in establishing this legal validity for foreign-issued documents.
Reference: EU MDR and IVDR framework.

Apostille: Definition and Legal Purpose in Turkey

An apostille is an international certification confirming that a document was officially issued and signed by an authorized authority in its country of origin. Turkey requires apostille for specific foreign documents to ensure authenticity and legal enforceability in accordance with the Hague Apostille Convention.

Without apostille, certain documents are considered legally unreliable, regardless of their technical correctness. As a result, ÜTS registrations involving non-apostilled core documents are frequently suspended or rejected.
Reference: Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents.

Documents That Require Apostille under ÜTS

Not all documents require apostille. However, the documents that do are fundamental to the entire registration process.

Declaration of Conformity

The Declaration of Conformity is the manufacturer’s formal and legally binding statement that the product complies with MDR or IVDR requirements. It is signed by the manufacturer and directly assigns legal responsibility. When this document is issued outside Turkey, apostille is mandatory for it to be accepted within the ÜTS system.

A Declaration of Conformity submitted without apostille is typically rejected or returned with a deficiency notice, halting the registration process.

EC Certificate

The EC Certificate applies to Class IIa, IIb, III, and IVDR-regulated products and is issued by a notified body to confirm that conformity has been assessed by an independent authority. In Turkey, submission of the certificate alone is not sufficient.

Authorities verify the legitimacy of the notified body, the validity period of the certificate, and the authenticity of the document itself. Apostille is therefore required to confirm that the certificate is legally valid and officially issued. An EC Certificate without apostille represents a significant compliance risk and often results in registration failure.

The Importance of Professional Regulatory Consulting

ÜTS registration is not a simple document upload exercise. It is a regulatory process that requires practical experience, procedural awareness, and familiarity with local administrative expectations.

Professional regulatory consultants determine which documents require apostille, when apostille should be obtained, how documents should be finalized before certification, and how Turkish authorities interpret regulatory requirements in practice. Manufacturers attempting to manage ÜTS registration without professional guidance frequently encounter repeated revisions, delays, and unnecessary costs.

Mandatory Turkish Translation Performed in Turkey

Equally important is the issue of translation. All documents submitted to ÜTS must be in Turkish, and these translations must be prepared in Turkey.

Translations completed abroad or generated through automated tools often contain terminology errors, regulatory inconsistencies, or expressions that conflict with Turkish regulatory language. Even when the original document is fully compliant, inaccurate translation alone can result in suspension of the registration process.

Professional medical translations performed in Turkey ensure not only linguistic accuracy but also correct regulatory terminology and alignment with local enforcement practices.

Documents That Do Not Require Apostille

There is a common misconception that every document must be apostilled. This is incorrect.

Documents that typically do not require apostille include Instructions for Use, product brochures, label samples, and technical drawings. However, these documents must still comply with MDR or IVDR, be translated into Turkish, and reflect correct medical and regulatory terminology. During inspections and market surveillance, these materials are closely reviewed.

A Frequent and Costly Error

One of the most expensive mistakes manufacturers make is obtaining apostille before documents are finalized. Any change made to a document after apostille, no matter how minor, invalidates the certification and requires the entire process to be repeated.

This leads to lost time, increased costs, and avoidable administrative setbacks.

Correct Regulatory Sequence

The correct process sequence is clear:

1. Prepare all documents in full compliance with MDR or IVDR.
2. Finalize the Declaration of Conformity and EC Certificate.
3. Obtain apostille for these finalized documents.
4. Complete professional Turkish translations in Turkey.
5. Proceed with ÜTS registration.

Conclusion

Apostille is not a minor administrative detail when entering the Turkish medical device market. For the Declaration of Conformity and the EC Certificate, it is a decisive compliance threshold.

When supported by professional regulatory consulting and high-quality local translations, manufacturers can significantly shorten registration timelines, reduce regulatory risk, and avoid costly errors. Turkey is a large and attractive market, but its rules are clear and strictly enforced. Documents must be technically accurate, legally valid, properly apostilled, and professionally translated by Turkish accredited public translators without exception. (source: Medikoz Çeviri)