In February 2020 the regulator cut the validity of every EC certificate issued by a UK notified body to 31 December 2020 in its national system, with no extension. UKCA appears nowhere in Turkish device law. And yet Türkiye may be the best place in the world for a UK manufacturer to obtain a CE certificate.
Saudi Arabia requires a Saudi-licensed representative. The UAE requires a UAE-licensed establishment. Egypt requires one of three Egyptian entities. Türkiye does not. Its Medical Device Regulation defines the authorised representative — yetkili temsilci — as a person established in Türkiye or in an EU member state, and TİTCK has confirmed that EU-established representatives carry the same rights and obligations as Turkish ones.
That is a direct consequence of the customs union, and it is the single biggest structural difference between this market and the other three. If you already hold an EU authorised representative for your MDR file, you may not need a second one.
Appointed in writing; jointly and severally liable with you for defective devices
Defined as a person placing a device from a third country on the Turkish market
Needs an authorisation certificate from the provincial health directorate before it may sell
Registers for a single registration number alongside the representative and importer
What this does not remove. The importer must still be established in Türkiye, and nobody may sell your device unless they hold a sales centre authorisation and the device is registered in the national system. The regulation makes that explicit: an authorised sales centre may not sell a device that is not registered. So you still need Turkish partners — you just do not need one of them to hold your regulatory file.
We searched the consolidated texts of both the Medical Device Regulation and the IVD Regulation. UKCA appears zero times. So does "Birleşik Krallık". So does "İngiltere". CE marking appears throughout, and Article 20 requires it on every device that is not custom-made or investigational.
More pointedly: TİTCK announcement 2020/KK-3, issued 13 February 2020, ruled that EC certificates issued by BSI Assurance UK (0086), Lloyd's Register Quality Assurance (0088), SGS United Kingdom (0120) and UL International UK (0843) would have their validity truncated to 31 December 2020 in the national system, after which the system would drop them and no extension would be granted. That is not an oversight about Brexit. It is a decision taken about it.
The only TİTCK document that mentions UKCA at all points the other way: a 2022 announcement telling Turkish manufacturers that they need a UK Responsible Person and MHRA registration to sell into Great Britain.
FDA clearance does not help either. Türkiye transposed EU MDR and IVDR wholesale. There is no reference-country list, no reliance route and no abridged assessment for a 510(k) or a PMA. The only currency is a CE certificate from a body the EU recognises.
Because Türkiye is inside the customs union for industrial goods, conformity assessment bodies designated there are treated as equivalent to those designated in EU member states, and their certificates are mutually recognised. In the European Commission's own database, three bodies established in Türkiye carry EU MDR numbers.
| NB number | Body | Legislation |
|---|---|---|
| 1984 | Kiwa Belgelendirme Hizmetleri A.Ş. | EU MDR 2017/745 |
| 2292 | UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi | EU MDR 2017/745 |
| 2764 | Notice Belgelendirme, Muayene ve Denetim Hizmetleri A.Ş. | EU MDR 2017/745 |
Read from the European Commission's EUDAMED notified-bodies module in September 2026, which returned 53 bodies in total. Türkiye is the only non-EU and non-EEA country among them. Two corrections to assumptions we have seen in the trade press: TSE does not appear in that list at all, and SZUTEST appears only as a German entity, not a Türkiye-designated one.
Two limits, and a caveat about our own source. All three are designated under MDR only — there is no IVDR notified body in Türkiye, so an in-vitro diagnostic cannot take this route. And we read the designations from EUDAMED rather than from NANDO, the formal designation register, which has migrated to the Commission's Single Market Compliance Space and did not respond when we tried it. EUDAMED is an official Commission database, but it is not the designation register, so we treat the absence of TSE as provisional and re-confirm any body before a client instructs it.
Türkiye runs everything through ÜTS, the national product tracking system. Certificates are registered first; products second; and neither can be sold until somebody holding a sales centre authorisation does the selling.
Under the Turkish regulation this is not optional and there is no substitute. Class I devices that are not sterile, not measuring and not reusable surgical instruments self-declare; everything from Class Is upwards needs a notified body. If your certificate came from a UK body, it has had no standing here since the end of 2020.
You, with usMandatory because you are established neither in Türkiye nor in the EU. The appointment takes effect when a mandate is issued and the representative accepts it in writing, and it must cover at least all devices in the same generic device group.
Us, with youManufacturer, authorised representative and importer each register for a single registration number before the device is placed on the market. Data must be updated within one week of any change, confirmed within a year and every two years after that. Distributors are outside this obligation and sit under the sales regime instead.
UsTwo separate filings in ÜTS, priced separately. The Turkish importer performs the document registration and uploads the mandate between you and your representative, with a sworn Turkish translation.
Importer, managed by usThe current Turkish user manual is uploaded to ÜTS in full, with its update date recorded. The language obligation comes from the product safety law by cross-reference rather than from the device regulation itself, but the system enforces it directly.
You, with usYour distributor needs a sales centre authorisation from the provincial health directorate. The directorate reviews documents within fifteen working days and inspects the premises within forty-five working days of the application.
Shared — we run the calendarThis is the exact inverse of Egypt, where the regulator publishes review periods in working days and not a single fee. TİTCK publishes a full annual tariff in Turkish lira, reissued during the year, and sets no published evaluation period for registration at all.
| Item | 2026 fee, ₺ |
|---|---|
| Product registration application, per application | 335 |
| Certificate registration, per document — EC certificate, declaration of conformity | 335 |
| Sales centre authorisation certificate | 3,617 |
| Free sale certificate, 1–50 products | 3,349 |
| Free sale certificate, 51–250 products | 6,634 |
| Free sale certificate, 251 products and above | 9,918 |
| Certificate extension application under EU 2023/607 | 4,637 |
| Device and class determination, per device | 51,527 |
| Placing-on-market notification permission | 12,881 |
| Economic operator registration in ÜTS | not charged |
TİTCK 2026 price tariff, version dated 23 March 2026. We searched all 332 rows for an ÜTS or economic-operator fee and found none, and there is no annual maintenance fee for a device registration. Fees are set by a published methodology and re-set at least annually; they are not, on any TİTCK publication we found, formally indexed to the revaluation rate. Amounts are paid to TİTCK and billed to you at cost. Get the current figures for your device →
There is no occurrence of "within … days" anywhere in the Medical Device Regulation as a limit on the authority. The deadlines that do exist run against you: payment for a free sale certificate within ten days or the application cancels itself, and an importer's obligation to act within two weeks of placing a device on the market. The only published authority-side periods we found are in the sales regime — fifteen working days to review documents and forty-five to inspect.
The UK and Türkiye have a free trade agreement in force since January 2021, and they amended it — the technical barriers to trade chapter was replaced by an exchange of letters dated 7 May 2025, laid before Parliament that September. Its two sectoral annexes cover chemicals and motor vehicles. There is no medical devices annex.
Negotiations for an enhanced agreement have run five rounds through June 2026, with eleven chapters reported closed. The published round summaries name digital trade, telecommunications, investment, legal services, goods market access, sanitary and phytosanitary measures, intellectual property, procurement and sustainability. Conformity assessment, mutual recognition and medical devices are not among them.
What we would tell a board. Do not sequence Türkiye on the expectation that UKCA becomes acceptable. Nothing published supports it, the one amendment made so far chose other sectors, and the practical alternative — a CE certificate from a notified body in Türkiye or the EU — is available today and opens the European market at the same time. We also could not confirm that the 2025 exchange of letters has entered into force, so we do not describe it as in force.
The Commission's formal designation register has moved to the Single Market Compliance Space and did not respond. The three Turkish notified bodies are confirmed from EUDAMED, an official Commission database but not the designation register.
Turkish public procurement law gives a price advantage of up to fifteen per cent for domestically produced goods, mandatory at fifteen per cent for goods on a designated medium and high technology list. We could not open the current list, so we cannot tell you whether your category is on it.
Signed 7 May 2025 and laid before Parliament, but we found no entry-into-force notice. An earlier version of the same instrument was withdrawn.
The regulation defines them as distinct roles without prohibiting combination, and requires only the importer to be Turkish. We found no guidance either permitting or forbidding it.
The social security institution's own page does not state it as a precondition and routes applications through its own portal. The health implementation communiqué is where any such rule would sit and we have not read it.
Everything on this page comes from Turkish-language sources: there is no official English text of either device regulation, of the tariff, or of the ÜTS guidance. Where we quote a requirement, we hold the Turkish original.
The first question is the one that decides the project. If your CE certificate was issued by a UK notified body, you do not have a Turkish registration problem; you have a certification problem, and it needs solving before anything else on this page is worth doing.
The other half of this market
The answer inverts. On the device side the UKCA mark is not recognised at all. On the medicines side Türkiye and the MHRA are both PIC/S participants, so the MHRA's inspection findings count — and the binding constraint becomes a pricing euro fixed by decree at sixty-five per cent of last year's average market rate.
The medicines page for Türkiye →
If your CE certificate is intact, Türkiye is a cheap and mechanical registration. If it is not, this is a certification project wearing a market-access costume — and we would rather tell you that on the first call.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Re-checked quarterly and after any amendment to the device regulations, any new TİTCK guidance, and each annual tariff. The tariff in particular moves within the year: the 2026 edition on this page is already the third version published in 2026.