TITCK Fee Tariff 2026 and the Fee Authority under Madde 105

1. Key takeaways

Fees charged by the Turkish authority do not come from a table inside the regulation itself. They rest on a delegation clause in the regulation and are carried by an annual tariff published by TİTCK. This article explains the delegation and its procedural guardrails, then lists the device-related fee items from the 2026 tariff as verified, with the caveat that those amounts are time-sensitive.

• The superior authorisation to charge fees is written in Madde 105 paragraph 1 of the Medical Device Regulation: the Kurum may determine the level of fees and charge them within the framework of the principles of transparency and cost recovery (maliyeti karşılama). The two principles are the constitutional boundaries of the fee power.
• Paragraph 2 of the same article sets procedural constraints: the structure and level of the fees must be notified to the Commission (Komisyon) and to the EU member states at least 3 months before publication; the structure and levels are open to the public upon request. The fee power is therefore bounded both in substance and in procedure, and the advance notification gives partners a defined window in which the coming fee structure becomes knowable.
• Current rates are issued in the form of the TİTCK annual price tariff (Fiyat Tarifesi), published on the official website under the section Kurum Hizmetleri Fiyat Tarifesi.
• From the obtained 2026 tariff (updated on 2026-03-23), the device-related items include (in Turkish lira, TL): product registration application 335 (with a domestic product support price of 201); EC certificate / declaration of conformity document registration 335; placing-on-market announcement permit 12,881; device and classification determination 51,527; first application for a clinical investigation of devices without CE marking 57,967; post-market study 25,763; scientific / educational activity application 2,012; sales centre authorisation certificate 3,617; free sale certificate 3,349 / 6,634 / 9,918; notified body designation assessment 772,906.
• These amounts are time-sensitive, and the tariff currently published on the TİTCK website prevails. Budgets and quotations must always be tied to the live version rather than to this snapshot, because each annual update of the tariff can move any line without separate notice to applicants.

2. Legal basis

The fee power sits in the regulation, while the amounts sit in the annual tariff document published by the institution. The table below records both layers, since a citation to fees is incomplete without both the article that empowers the charge and the tariff version that carries the number.

3. Expert insights

Insight one: Turkish device fees run through a tariff, not a regulation annex. Madde 105 provides only the principles (transparency and cost recovery) and the procedure (notification 3 months in advance); the concrete amounts are carried by the institution’s annual tariff. As a result, every annual update can change the budget structure. Building this year’s budget on last year’s table is unsafe, and the correct discipline is to re-pull the live tariff at the start of every budgeting cycle and again before every submission.

Insight two: the fee distribution shows a clearly high-value end. Routine registration items sit in the three-digit band (335), while determination and assessment items jump to the tens or hundreds of thousands (51,527 up to 772,906). This structure signals where budget risk actually lives: the amounts that companies genuinely need to reserve for are the determination and assessment expenses triggered by uncertainty, not the basic registration fees. A budget that covers only the registration items has covered the cheapest part of the journey.

Insight three: the domestic product support price is a usable differentiator. The product registration application carries two values, the standard 335 and the support price of 201. For companies with a local manufacturing entity in Turkey this is a defined cost advantage; for purely export-based companies, the standard rate must be built into commercial calculations. Establishing early which of the two applies to a given project avoids pricing errors in partner quotations.

4. Practical recommendations

• Build every budget on the basis of the current official tariff plus a volatility reserve, and never apply historical figures directly to current projects, since the annual update cycle can move the numbers without notice.
• When quoting to Turkish partners, state the currency unit (TL) and the tariff version date (for example 2026-03-23) explicitly, avoiding later disputes over exchange rates and version differences.
• Communicate in advance whether determination-type, assessment-type or study-type fees may be triggered, and write the possibilities and their amount ranges into the contract annex, so that cost surprises become negotiated items rather than conflicts.

5. Verification checklist

• □ Madde 105 has been cited as the source of the fee power, and the principle of transparency plus cost recovery is understood.
• □ Amounts have been checked against the current TİTCK tariff (the version updated on 2026-03-23 served as the basis of this verification).
• □ Quotations state the currency unit TL and the tariff version date.
• □ It has been identified whether the project triggers determination-type / assessment-type high-value items or clinical study-type fees.
• □ The possible applicability of the domestic product support price (201 vs 335) has been checked.

Regulatory information verified as of 29 October 2026. The Madde 105 provisions in this article were checked against the current texts on the Turkish legislative information system (MevzuatNo 38657); the amounts were taken from the 2026 tariff published on the TİTCK website (update date 2026-03-23) and are time-sensitive; actual payments are governed by the current figures on the official 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 coordinates authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com