Turkish Authorised Representative Requirements under Madde 11 of the Medical Device Regulation

1. Key takeaways

For manufacturers outside Turkey and the European Union, the appointment of a Turkish authorised representative is the single entry gate to the market. The rules below are taken directly from Madde 11 of the Turkish Medical Device Regulation, and they operate as strict preconditions rather than best-practice suggestions. Read them as a sequence: first confirm that the appointment is actually required, then make sure the appointment is validly formed, then check that its scope is wide enough, and finally document the tasks and the change mechanism.

• The authorised representative in Turkey is a mandatory market access prerequisite, not an optional service. Madde 11, paragraph 1 provides that where a manufacturer has no establishment in Turkey or in an EU member state, its devices may be placed on the market only after it has appointed an authorised representative. Without that appointment, placing on the market is simply not permitted.
• The conditions for the appointment to take effect are set out in Madde 11, paragraph 2: the manufacturer must issue the authorisation document (yetki belgesi) and the authorised representative must accept it in writing. Both elements must exist. If either one is missing, the appointment is not formed and the representation relationship does not legally exist.
• The scope of the authorisation has a mandatory floor: paragraph 2 requires the authorisation to cover at least all devices within the same generic device group (aynı jenerik cihaz grubu). This means that the practice of authorising the representative model by model, one certificate per SKU, does not satisfy the requirement. The unit of authorisation is the generic device group, not the individual model.
• Madde 11, paragraph 3 requires that the authorisation document list at minimum the baseline task list of the authorised representative, and that the manufacturer provide the conditions needed for the representative to perform those tasks. The authorised representative must also provide a copy of the authorisation document to the Kurum upon request, so the document must remain retrievable at all times.
• Detailed arrangements for changing the authorised representative are set out separately in Madde 12, and the change mechanism should be anticipated in the original contract rather than improvised when a change becomes necessary.

2. Legal basis

The obligations summarised above rest on two parallel regulations published on the same day in the same issue of the Official Gazette. The Medical Device Regulation governs devices, while the In Vitro Diagnostic Medical Devices Regulation carries the corresponding arrangement for IVDs. The table below records the instrument names in Turkish, the gazette reference, the publication date, and the specific articles on which each point in this article relies.

3. Expert insights

Insight one: the place-of-establishment test is a rigid rule. The trigger in Madde 11 is the place of establishment of the manufacturer, and it is assessed without reference to who physically imports the product into Turkey. Even where a Turkish importer already carries out all warehousing and customs clearance on the manufacturer’s behalf, the authorised representative remains indispensable as long as the manufacturer has no establishment in Turkey or in an EU member state. In multiple project reviews, GRZAN has found that equating a statement of we-have-an-importer with a conclusion of we-do-not-need-a-representative is the most common compliance gap observed among Chinese manufacturers entering Turkey. The two roles answer different questions, and one cannot substitute for the other.

Insight two: the authorisation must be closed as a loop through written acceptance. The wording of paragraph 2 is that the document is issued and (ve) accepted in writing by the authorised representative. In practical terms this requires the Chinese manufacturer to hold a confirmation letter signed by the representative, rather than merely delivering a stamped Chinese-language authorisation letter and considering the work done. Without that counter-signed acceptance on file, if a dispute later arises over the scope of the representative’s duties, the manufacturer will struggle to prove that the representation relationship was ever validly formed. The acceptance letter is therefore not a formality but the evidentiary heart of the arrangement.

Insight three: the generic device group as the minimum unit constrains splitting. The authorisation must cover all devices within the same generic device group. This design prevents companies from fragmenting the authorisation in order to disperse responsibility or reduce fees. For Chinese companies it also carries a positive application: provided that the boundary of the generic device group is reasonably defined, a single authorisation can cover an entire product line, with no need to pay per SKU. Getting the group definition right at the drafting stage is therefore where the economic value of the authorisation is decided.

4. Practical recommendations

• Draft the authorisation document following the customary structure used on the Turkish side: identification of both parties, entry into force and term, the list of covered generic device groups, the minimum task list, the clause on providing copies to the Kurum, and the termination and amendment clauses. Following the expected structure reduces friction during review and later audits.
• Obtain the written acceptance letter from the authorised representative and archive it together with the authorisation document as one complete file, so that formation of the appointment can be demonstrated on demand.
• Clarify within the corporate group that only one Turkish-side representative is appointed for the same generic device group, avoiding conflicts caused by duplicate appointments through several internal entities of the same group.

5. Verification checklist

• □ It has been confirmed that the manufacturer has no establishment in Turkey or in any EU member state, thereby triggering Madde 11 paragraph 1.
• □ The yetki belgesi (authorisation document) has been issued and written acceptance from the representative has been obtained.
• □ The scope of the authorisation covers at least all devices within the same generic device group.
• □ The minimum task list in the authorisation document is complete, and the arrangement for providing copies to the Kurum has been agreed.
• □ The change mechanism has been written into the contract in accordance with the principles of Madde 12.

Regulatory information verified as of 29 October 2026. The provisions cited in this article were checked against the current texts on the Turkish legislative information system (MevzuatNo 38657, 38658).

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