Annex XVI Reclassification of Products Without a Medical Purpose in Turkey

1. Key takeaways

Turkey brings certain products without a medical purpose into device regulation through a dedicated reclassification regulation. The classification outcomes in Madde 4 of that regulation push well-known aesthetic and wellness product groups into class IIa, IIb or III, and one same-subject entry dated 2026 remains pending verification. This article sets out the classification map and the tracking point.

• Turkey brings certain products without a medical purpose into device regulation, and has issued a dedicated reclassification regulation: the Regulation on the Reclassification of Certain Groups of Active Products Without a Medical Purpose (Tıbbi Amaçlı Olmayan Belirli Aktif Ürün Gruplarının Yeniden Sınıflandırılmasına İlişkin Yönetmelik), published in the Resmî Gazete on 17 August 2024 in issue 32635, with legislation information system number MevzuatNo 40924.
• Madde 4 of the regulation gives three explicit classification assignments:
  • Annex XVI point 4 (fat-reduction devices) falls in class IIb;
  • Annex XVI point 5 (devices emitting high-intensity electromagnetic radiation) falls in class IIb; devices intended exclusively for hair removal fall in class IIa;
  • Annex XVI point 6 (brain stimulation devices) falls in class III.
• The impact is structural: products that might otherwise have been treated as ordinary industrial goods or aesthetic instruments now enter the IIa / IIb / III framework in Turkey and require full conformity assessment and technical documentation.
• One further item requires continuing attention: the TİTCK legislation library also lists a same-subject regulation with a marked date of 2026-02-27, but no corresponding entry was found in the Resmî Gazete table of contents for that day, and its gazette issue number has not been obtained; it is treated as a practical estimate, pending verification.

2. Legal basis

The classification map rests on the reclassification regulation and its anchor in the device regulation, with one additional same-subject entry in the TİTCK library that is not yet anchored to a gazette issue. The table below records all three.

3. Expert insights

Insight 1: this round of reclassification moves aesthetic instruments into the high-risk device space. A device emitting high-intensity electromagnetic radiation, if not confined to hair removal, lands directly in class IIb; brain stimulation devices land in class III, which is the same regulatory intensity as cardiac implants. Companies making aesthetic energy-based devices and exporting them to Turkey on the assumption that they are non-devices face a clear and material compliance gap. The correct starting point is a classification trial against Madde 4, not a judgement based on how the product is marketed elsewhere.

Insight 2: hair removal is singled out for a lower class. Madde 4 subdivides the point 5 products by intended use: devices used exclusively for hair removal fall in class IIa, all others in class IIb. This shows that intended use is a decisive variable in this classification round, just as it is in the general rules. The instructions for use and claims texts must match the actual marketed configuration exactly; otherwise a company may lose the lower class it could otherwise have claimed. The saving depends on the documentation, not on the engineering alone.

Insight 3: the entry dated 27 February 2026 deserves continuing tracking. The TİTCK legislation library marks a same-subject regulation, but no corresponding item could be located in the Resmî Gazete table of contents for that day. Such a difference may arise from an index that has not yet been updated in the gazette table of contents, or from an internal institutional numbering. GRZAN advises clients to list this item as pending verification rather than citing it directly, and to update the internal ledger only once the gazette issue number has been obtained.

4. Practical recommendations

• For any product involving fat reduction, high-intensity electromagnetic radiation or brain stimulation, run a classification trial against class IIb / III first, then build the market access route and budget on that basis.
• Ensure that instructions for use and claims texts correspond exactly to the intended-use configuration selected (especially the lower class for exclusive hair removal use).
• Keep tracking the 2026-02-27 entry, and update the internal ledger only after the gazette issue number has been obtained.
• Treat the classification outcome as a board-level cost item, since conformity assessment for IIb and III products materially changes the certification plan.

5. Verification checklist

• □ Whether the product falls within the Ek XVI list has been confirmed.
• □ The IIa / IIb / III classification trial under Madde 4 of Sayı 32635 has been completed.
• □ Fat-reduction products have been treated as IIb; high-intensity electromagnetic radiation products have been differentiated as IIb / IIa by use; brain stimulation products have been treated as III.
• □ Claims texts are consistent with the actual intended-use configuration.
• □ The same-subject regulation dated 2026-02-27 has been placed on the list of items pending verification (practical estimate).

Regulatory information verified as of 29 October 2026. The regulation name, issue number (Sayı 32635), date (2024-08-17), MevzuatNo 40924 and the Madde 4 classification assignments cited in this article were checked against the original texts of the Resmî Gazete and the legislation information system; the gazette issue number of the 2026-02-27 entry has not been obtained and it is treated 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 manages adverse event reporting and recall coordination with TITCK, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com