Legal Basis of TITCK: Presidential Decree No. 4, Articles 508 and 796

1. Key takeaways

This article traces the legal origin of the authority that regulates medical devices in Turkey. Every discretionary power that a company will encounter in a Turkish registration file ultimately rests on two instruments: the Presidential Decree that establishes TİTCK and the Law on Product Safety and Technical Regulations that empowers the device Regulation. Understanding this chain is the first step in making any Turkish citation verifiable.

• The Turkish Medicines and Medical Devices Agency (TİTCK) is subordinate to the Ministry of Health of the Republic of Turkey (T.C. Sağlık Bakanlığı). Its organic law basis comes from Articles 508 and 796 of Presidential Decree No. 4, which was published on 15 July 2018 in Official Gazette issue 30479. These two articles are the provisions a Turkish counterparty will expect to see whenever the competence of the agency is invoked in correspondence, audit responses or appeal documents.
• The legislative basis clause of the device Regulation (Madde 2) states expressly that the Regulation is enacted on the basis of Article 4 of Law No. 7223 on Product Safety and Technical Regulations dated 5/3/2020, together with Articles 508 and 796 of the aforementioned Presidential Decree No. 4.
• The execution clause of the Regulation is Madde 112, which provides in plain words that the provisions of the Regulation are executed by the President of TİTCK. This is the statutory basis for placing a large discretionary centre at the level of the agency.
• Throughout the Regulation the competent authority is referred to as the Kurum. Wherever the word Kurum appears in a provision, the discretionary subject is TİTCK.

2. Legal basis

The table below records the three instruments that together define who regulates medical devices in Turkey and under what authorisation. Note that the full Turkish title of the Presidential Decree is long but should be kept intact in internal regulatory ledgers, because it identifies the decree unambiguously and allows any counterparty to verify the citation without guesswork.

3. Expert insights

Insight 1: why Articles 508 and 796 must be cited side by side. The two articles correspond to different aspects of the establishment of the agency and the allocation of its duties. Madde 2 of the Regulation places them alongside Article 4 of Law No. 7223, forming a dual basis of statutory authorisation plus organisational empowerment. This structure means that the powers of TİTCK are constrained by substantive law and also supported by organisational law. If a company wishes to challenge a specific decision, it needs to examine whether the authorisation holds at each of these two levels separately.

Insight 2: Kurum is a high-frequency word and the key entry point for understanding the Turkish system. Across the 111 articles of the Regulation and its annex system, the word Kurum appears at decisive positions: the adjudication of classification disputes (Madde 51 paragraph 2), the designation of notified bodies (from Madde 35), the making of ÜTS rules (Madde 34 paragraph 2) and the assessment of vigilance reports (Madde 87 paragraph 2). Reading Kurum simply as a drug agency understates the density of its powers, because in Turkey it also regulates medicinal products, cosmetics and biocidal products at the same time. A citation map that tracks where Kurum appears is therefore the most economical way to understand the perimeter of the agency’s discretion before any submission is drafted.

Insight 3: Madde 112 assigns the executive power expressly to the president of the agency. The technical meaning of such a clause is that the operational interpretation of the Regulation is highly concentrated inside TİTCK. For export companies this means that the value of a written consultation, in which a case-specific question is submitted to TİTCK, is higher than the value of a private inference drawn from the wording of the Regulation. When handling comparable uncertainties, GRZAN tends to break a question down into concrete points of judgment that can be answered in writing, rather than asking in general terms. A narrowly framed question shortens the reply cycle and produces an answer that can be archived and reused across projects, whereas an open-ended question often returns a reply so general that it cannot support any file entry.

4. Practical recommendations

• In the internal regulatory ledger, record the basis of TİTCK as the complete three-part citation of Presidential Decree No. 4 Madde 508 and 796 plus Law No. 7223 Madde 4, so that the citation chain does not become unverifiable through an entry that only says Turkish health authority.
• For judgments on product attributes, classification placement and whether an exemption is available, give priority to written consultation, and keep the written reply of TİTCK in the registration file.
• Monitor the two website sections Mevzuat and Kılavuz on the TİTCK website. Amendments to the Regulation are published through the Resmî Gazete, while operational documents are issued at a higher frequency, and the two channels cannot substitute for each other. A company that watches only the gazette will see the amendments but miss the guides that explain how the amendments are applied at the counter; a company that watches only the guides loses sight of the binding text. Both readings are needed to keep the internal position aligned with what TİTCK actually enforces.

5. Verification checklist

• □ Citation check: whether the basis of the agency is Presidential Decree No. 4 Madde 508 and 796, and whether the gazette is Sayı 30479 of 2018-07-15.
• □ Higher-law check: whether it is Law No. 7223 Madde 4, and whether the date is 2020-03-05.
• □ Confirm that the matter intended for consultation falls within the competence of the Kurum (compare Madde 51, Madde 34, Madde 35 and Madde 87).
• □ Confirm that an archived version of the written reply of TİTCK, together with its date, has been retained.
• □ Confirm that website monitoring covers the 2 entries Mevzuat and Kılavuz.

Regulatory information verified as of 29 October 2026. The articles and reference numbers listed in this article were checked line by line against the Turkish Official Gazette and the original text in the Legislation Information System (MevzuatNo 38657).

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 manages TITCK registrations aligned with the EU MDR/IVDR framework, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com