Power of Attorney, Notarisation and Translation for Turkish Medical Device Authorisation Documents

1. Key takeaways

The authorisation document, known in Turkish as the yetki belgesi, is one of the core items of compliance evidence on the Turkish side. This article looks at what the Medical Device Regulation actually demands of that document, who must be able to see it, and how it should be handled over its working life. The key points are as follows.

• The authorisation document (yetki belgesi) is a core piece of compliance evidence on the Turkish side. Madde 11 paragraph 2 requires that it be issued and that it be accepted in writing by the authorised representative. Issuing alone does not complete the act; the written acceptance is an equally required element.
• Madde 11 paragraph 3 goes further: the authorisation document must contain at minimum the baseline task list of the authorised representative, the manufacturer must provide the conditions for the representative to perform those tasks, and the authorised representative must provide a copy of the authorisation document to the Kurum upon request.
• Together these provisions mean that the authorisation document will be touched by at least three parties: the manufacturer, the authorised representative, and the Kurum. It is therefore no longer merely a commercial contract between two commercial parties; it is a compliance document that can be inspected by the regulator whenever the regulator chooses to ask for it.
• The specific acceptance criteria for language and certification steps, such as notarisation and the Turkish-language translation, are not itemised provision by provision in the regulation itself. This layer is operational and must be handled according to TİTCK guidance and case-by-case official responses (practical estimate).

2. Legal basis

Two provisions anchor this topic. The first defines how the authorisation document is formed and what it must contain; the second defines how long related documentation must be kept, which is the natural yardstick for deciding how long the authorisation document itself should be retained. Both sit in the same regulation, published in the same gazette issue.

3. Expert insights

Insight one: the authorisation document is a three-stage chain of evidence. The first stage is issuance, which is the expression of intent by the manufacturer. The second stage is acceptance, which is the expression of intent by the representative. The third stage is usability, meaning the document can be produced to the Kurum immediately upon request. Companies typically invest effort only in the first stage, which leaves the second stage missing and the third stage unable to respond in time. A document that exists but cannot be shown quickly, or that was never formally accepted, fails the purpose for which the regulation requires it.

Insight two: the retention period shares its origin with the technical documentation. Madde 10 paragraph 8 requires the manufacturer to keep the technical documentation, the declaration of conformity and the related certificates for at least 10 years, extended to 15 years for implantable devices. The authorisation document is not named in the list of items set out in that paragraph, but because it is the legality precondition for placing devices on the market, it is recommended to retain it for an equivalent period, and the period should run no shorter than the stated number of years after the last device has been placed on the market. Aligning the two retention clocks avoids the awkward situation of holding technical files for a device whose authorisation evidence has already been destroyed.

Insight three: the certification chain is a cost centre and a rejection hotspot at the operational level. Every change made at the notarisation, translation or legalisation stage triggers a redo of the affected links. The difficulty frequently seen on the Chinese side is that the translation does not match the final executed draft, which forces the entire certification chain to be redone from the beginning. The recommended sequence is to settle the final Turkish-language text first and have both parties sign only afterwards, so that the signed document and the certified translation can never drift apart.

4. Practical recommendations

• Adopt a structure of dual signature plus a written acceptance letter, and bind the acceptance letter together with the authorisation document into a single dossier, so that formation of the appointment can be evidenced as one complete package.
• Provide in the contract that termination and any change of the authorisation are handled according to the detailed arrangements of Madde 12, and agree in the same clause the responsibilities for recovering the documents and for notifying the Kurum side.
• Align the retention period of the authorisation document with the technical documentation (10 years / 15 years for implantables), and enter it into an expiry reminder ledger so that the deadline is tracked actively rather than discovered late.

5. Verification checklist

• □ The authorisation document has been issued, and the authorised representative has accepted it in writing.
• □ The authorisation document includes the minimum task list required by Madde 11 paragraph 3.
• □ The mechanism and time limit for providing the document to the Kurum have been agreed.
• □ The language version (Turkish) and the certification chain have been handled according to the acceptance practice of TİTCK (as a practical estimate, the official response prevails).
• □ The retention period of the authorisation document has been aligned with that of the technical documentation.

Regulatory information verified as of 29 October 2026. The provisions cited in this article were checked against the current texts on the Turkish legislative information system (MevzuatNo 38657); no official itemised list on the acceptance of notarisation and translation has been obtained, and the related statements are handled as a practical estimate.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team coordinates authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com