Free Sale Certificate Use and Cost in Turkey

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The free sale certificate is one of the most frequently requested documents from TİTCK, because third-country registrations routinely ask for proof that a product is lawfully on the Turkish market. This article explains what the certificate actually certifies, what it costs under the 2026 tariff, on what market status it depends, and the rejection reasons that applicants encounter most often. Understanding all four points together turns the certificate from an administrative chore into a predictable step in the export chain.

  • The free sale certificate (Serbest Satış Sertifikası) is a certifying document issued by TİTCK, commonly used as proof of lawful marketing when registering the product in third countries. Its value abroad depends entirely on the market status it reflects at home.
  • In the 2026 tariff (updated on 2026-03-23), the item is listed at three tiers: 3,349, 6,634 and 9,918 Turkish lira. The conditions of application of the three tiers (such as the number of destinations, language, or additional legalisation) are governed by what TİTCK publishes for the current period (practical estimate).
  • The precondition of the certificate is that the product holds a lawful marketing status in Turkey. Where ÜTS-side registration is missing or the CE certificate has lapsed, an application for a free sale certificate has no foundation and cannot proceed.
  • Common rejection reasons concentrate in three places: inconsistency between the name and the model designations, CE certificate scope not covering the models applied for, and missing or expired authorisation documents. All three are items that can be self-checked before submission, which makes most rejections avoidable with preparation.

2. Legal basis

Three layers of documents govern this topic: the tariff that carries the fee, the institutional procedure on how fees are determined and updated, and the device regulation provisions on CE marking and placing on the market that define the lawful status the certificate attests to. The table below records all three.

InstrumentOriginal Turkish nameReferencePublication dateItems / articles
TİTCK 2026 price tariff2026 Yılı Fiyat TarifesiTİTCK website, section Kurum Hizmetleri Fiyat TarifesiUpdate date 2026-03-23Free sale certificate entry (3,349 / 6,634 / 9,918 TL)
Procedure and principles on determining and updating service feesHizmet Bedellerinin Belirlenmesi ve Güncellenmesine İlişkin Usul ve EsaslarTİTCK institutional document2024-01-03Articles 3, 4(1)c, 5(1), 8(4), 9(2)
Medical Device Regulation (CE and placing-on-market preconditions)Tıbbi Cihaz YönetmeliğiResmî Gazete Sayı 31499 (1. Mükerrer)2021-06-02Madde 20, Madde 105

3. Expert insights

Insight one: the free sale certificate certifies a status; it does not confer a qualification. What it proves is the current situation of the product in Turkey, and it creates no new rights beyond that proof. For that reason, presenting it in third-country registration dossiers as if it were a qualification document is inaccurate and invites challenge. The safer formulation is to describe it as a certificate of marketing status issued by the competent Turkish authority. Getting this characterisation right matters when foreign reviewers challenge what the document actually establishes, and it also keeps internal expectations realistic about what the certificate can and cannot support in other markets.

Insight two: the three-tier fee structure typically corresponds to copies, language and certification strength. The fact that the tariff expresses the item as three separate values indicates that selectable options exist, such as whether additional copies are needed, whether a specific language is required, or whether additional legalisation is involved. Because the rules governing the selectable options are fixed by the operational layer of the institution, the applicable tier must always be confirmed against what TİTCK publishes for the current period and against case-by-case official responses (practical estimate).

Insight three: most rejection reasons are preventable data inconsistencies. Name and model strings are written differently across different certificate systems (spacing, hyphens, suffixes), and this is the most common rejection point. GRZAN recommends performing a three-document alignment before submission: the name and model on the CE certificate, in the ÜTS registration information, and on the free sale certificate application must match character by character. A single mismatched suffix is enough to send the file back and restart the clock. Because the check is purely mechanical, it can be delegated to any trained team member and completed in minutes, which makes leaving it undone the least excusable cause of a rejection.

4. Practical recommendations

  • Build a three-document alignment worksheet: compare the name and model character by character across the CE certificate, the ÜTS registration and the application form, so that string mismatches are caught before the authority sees them.
  • Before submission, confirm that the CE certificate remains valid on the application date and that its model scope covers the models applied for, since both gaps are direct rejection grounds.
  • Reserve the higher tier of the tiered fee (9,918 TL) as the budget ceiling, avoiding progress delays caused by supplementary payments midway through the process.

5. Verification checklist

  • □ It has been confirmed that the product holds a lawful marketing status in Turkey.
  • □ The applicable fee tier for the free sale certificate (3,349 / 6,634 / 9,918 TL) has been determined for the organisation.
  • □ Character-by-character alignment of names and models has been completed across the CE certificate, the ÜTS registration and the application.
  • □ The authorisation document (where applicable) is within its validity and has completed written acceptance.
  • □ The quotation and budget have reserved the higher tier and a time buffer.

Regulatory information verified as of 29 October 2026. The amounts in this article were taken from the 2026 tariff published on the TİTCK website (update date 2026-03-23); the rules on applying the tiers are not itemised in the body of the official regulation, and the related statements are handled 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 coordinates authorised representative and importer arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.

What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

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