How to Search Turkish Regulations Through Official Sources

1. Key takeaways

Anyone who builds a Turkish regulatory file needs to know where the official texts live and how to cite them so that a third party can find the same provision. Turkey offers two complementary official channels, the Official Gazette and the consolidated legislation system, plus the agency’s own regulation and guide libraries. The points below explain how to use all three and how to cite what they provide.

• The Turkish Official Gazette (Resmî Gazete) is indexed by date and issue number (Sayı); the same date may carry an original issue and repeated issues (Mükerrer), and the repeated issue number must be stated when citing. Both the device and the IVD regulations were published on 2021-06-02 in Sayı 31499 (1. Mükerrer). Because the gazette is the channel of first publication, it remains the reference of last resort whenever two sources appear to disagree about the wording of a provision.
• The Turkish Legislation Information System (Mevzuat Bilgi Sistemi) provides consolidated current texts; the device Regulation carries the number MevzuatNo 38657 and the IVD Regulation MevzuatNo 38658. The consolidated texts already merge the three amendments and are suitable as the daily citation source.
• The annexes (Ek) must be downloaded separately. The classification rules (Ek VIII) and the general safety and performance requirements (Ek I) sit in separate annex files outside the main text; reading only the main text PDF will miss the classification rules themselves. Teams that inherit a folder containing only the main text should treat the absence of the annex files as a gap to be closed before any classification decision is signed off.
• The recommended unified citation format is: original Turkish name of the regulation (translated name) | Resmî Gazete Sayı issue number | publication date | Madde article number / Ek annex number, with all four elements complete.

2. Legal basis

The three official resources below are the reference points against which every Turkish citation in this series was verified. The verification date is recorded for each, so that the currency of the information can be judged and the next review window can be scheduled.

3. Expert insights

Insight 1: Mükerrer is not a typographical detail but a matter of locating precision. The gazette of 2 June 2021 exists in a repeated-issue version, and the device Regulation is located in the first repeated issue (1. Mükerrer). If a citation writes only Sayı 31499 without the repeated issue, a verifier looking under that issue number may fail to find the target regulation, or may find another instrument published on the same day. The failure is silent: the citation looks complete, yet it cannot be resolved, and the file reviewer may simply record it as unverifiable rather than querying it.

Insight 2: the consolidated text and the original publication text each have their own use. The text No. 38657 given by the Legislation Information System has already merged the three amendments; it is lighter to read, and each amended article carries a clear annotation of its amendment source. The original gazette PDF serves to confirm the wording of a provision as first published in a given version. For compliance arguments, manage the daily work on the former and return to the latter when a dispute arises. Keeping both files side by side in the same folder, with the verification date in the file name, makes the switch between daily reading and dispute reconstruction a matter of seconds rather than a search exercise.

Insight 3: the annexes are where classification and the GSPR actually live. The classification rules are in Ek VIII, the general safety and performance requirements in Ek I, the technical documentation requirements in Ek II and Ek III, the conformity assessment procedures in Ek IX, Ek X and Ek XI, the custom-made device requirements in Ek XIII and the clinical evaluation in Ek XIV. None of these judgments can be completed from the 111-article main text alone. A compliance team that has never opened the annex files will therefore produce classification arguments that look reasoned but rest on rules it has never actually read, which is the most expensive way to be wrong about a product class.

4. Practical recommendations

• Establish a Turkish regulatory ledger template inside the company, with the four elements (name, reference number, date, article) as mandatory fields. A mandatory-field design matters more than the template itself, because it prevents half-citations from entering the ledger in the first place instead of requiring later clean-up.
• When downloading a regulation, save the main text and the Ek annexes together, and record the version number and the verification date in the file name.
• Review once every quarter whether the current text in the Legislation Information System has been updated; after an update, record the new version number and an update note in the ledger.

5. Verification checklist

• □ Does the citation state the repeated issue (1. Mükerrer)?
• □ Is the distinction made between the consolidated text (MevzuatNo 38657 / 38658) and the original gazette issue?
• □ Have the relevant Ek annexes been downloaded and archived (classification rules in Ek VIII, GSPR in Ek I)?
• □ Is the verification date recorded, and does it fall within the most recent quarterly review window?
• □ Has a unified citation format been established and enforced in all external documents?

Regulatory information verified as of 29 October 2026. The official resources and numbers listed in this article were checked against public information of the Resmî Gazete, the Mevzuat Bilgi Sistemi and the TİTCK website.

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