Medical Device Definition and Product Boundary in Turkey

1. Key takeaways

Whether a product is a medical device in Turkey is decided by the definition clause of the Regulation, backed by an explicit power of the agency to rule on doubtful cases. Because software is written into the definition and a separate regulation governs products carrying health claims, the boundary of the device category is both wider and more institutionally controlled than in many other markets. The points below map that boundary.

• The device definition in Turkey is fixed in the definition clause of the Regulation, Madde 3, and Madde 3 paragraph 1 point (b) sub-item 2 expressly lists yazılım (software) as a device, placing it at the same time within active devices (aktif cihaz).
• Where the attribute of a product is in doubt, it is the Kurum (TİTCK) that rules whether a specific product, product category or group is a medical device or an IVD, on the basis of Madde 4. This is an institutional-level discretion, not a self-assessment by the company.
• The Regulation sets basic requirements for devices that are correctly installed, properly maintained and used as intended (Madde 5), and makes separate provision for devices provided through information services (Madde 6) and for medical device nomenclature (Madde 7).
• Products involving health claims are regulated by an independent regulation. The TİTCK regulation library lists the Regulation on the Inspection of Health Claims (Sağlık Beyanı Denetimi Hakkında Yönetmelik), with a publication date of 2026-02-04 (as marked in the agency’s regulation library; the gazette issue number was not obtained this time and the matter is treated as a practical estimate).

2. Legal basis

The definition and boundary of the device category rest on the definition articles of the two 2021 regulations, supplemented by a dedicated instrument on health claims. The gazette issue of the last instrument could not be verified against the original text at the time of writing and is flagged accordingly, while all other entries below were verified against the consolidated Turkish texts.

3. Expert insights

Insight 1: the definition determines the regulatory path, and the ruling on the attribute must be made by the institution. In many markets a company may decide for itself whether a borderline product is a device and bear the downstream risk; Turkey has expressly taken this decision into Madde 4. For products that combine features of foods, cosmetics or general consumer goods, for example dressings with functional claims, oral care products or fat-reduction devices, both advancing into the device path and evading the device path in Turkey carry the risk of being corrected. The correction is costly not because the rules are severe but because the whole file, the labelling and the distribution arrangements were built on the wrong premise.

Insight 2: software is written expressly into the definition, which is the precondition of the later classification. Madde 3 places software within the scope of devices, which allows Rule 11 of Section 6.3 of Ek VIII (the software classification rule) to operate on all standalone software. The consequence of this chain is that a digital tool managed by a Chinese company as a software product may need to be handled as Class IIa or higher when it enters Turkey.

Insight 3: the backfill effect on non-medical products. A number of beauty, fat-reduction and high-intensity electromagnetic radiation products have been placed under the Ek XVI list of the Regulation and were moved back into Classes IIa, IIb and III through a dedicated regulation on 27 February 2026. In Turkey such products are no longer general industrial goods. Article 48 of this series treats this change in a dedicated article.

4. Practical recommendations

• At the product initiation stage, ask the three attribute questions: whether the product is a device (Madde 3), whether it is an IVD (Madde 3 of the IVD Regulation), and whether it falls within the Ek XVI list. Do not open a project while any of the three questions remains unresolved. The three questions take little time at the beginning of a project and are far cheaper than reworking a file that has been built on the wrong regulatory path.
• For borderline products, submit a written attribute consultation to TİTCK and retain the reply, avoiding the substitution of a commercial judgment for the judgment of the institution.
• Review the claims wording of the product. Any statement involving the diagnosis, treatment, alleviation or prevention of disease may be treated as a device function, and the claims and the regulatory path must be consistent with each other. Reviewing the claims once before submission is enough to catch most mismatches; reviewing them again after translation is equally important, because wording changes introduced during localisation can create claims that never existed in the original text.

5. Verification checklist

• □ The device attribute of the product has been confirmed against the definition clause of Madde 3.
• □ If the attribute was in doubt, a written judgment of TİTCK under Madde 4 has been obtained.
• □ For products containing standalone software, classification has been completed under Rule 11 of Section 6.3 of Ek VIII.
• □ It has been confirmed that the product does not fall within the Ek XVI list of non-medical products (or has been handled under the reclassification regulation).
• □ The claims wording is consistent with the regulatory path selected, and no health claims beyond the scope exist.

Regulatory information verified as of 29 October 2026. The articles listed in this article were checked against the original text in the Turkish Legislation Information System (MevzuatNo 38657 and 38658); the gazette issue of the Regulation on the Inspection of Health Claims was not obtained from the original text, and the related statements are treated as 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 manages TITCK registrations aligned with the EU MDR/IVDR framework, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com