Türkiye TİTCK 2026/KKB-2: ÜTS E-Signature Document Uploads

On 2 November 2026, the Turkish Medicines and Medical Devices Agency (TİTCK) published Announcement 2026/KKB-2. It provides an importer secure e-signature option for uploading foreign manufacturers' conformity documents to Türkiye's Product Tracking System (ÜTS). MDR denotes the EU Medical Device Regulation.

The official announcement and annexes amend the ÜTS registration guideline that took effect on 13 May 2026. They cover declarations of conformity, EU/EC notified-body certificates, and MDR Article 22 system and procedure pack (SİP) declarations. The changed provisions govern submission format and verification for these documents.

What changed in the guideline?

The preamble explains that the previous foreign-manufacturer e-signature options in Articles 12(1)(ç) and 15(1)(ç) were difficult to verify in practice. It identifies documents signed through applications such as AdobeSign or DocuSign without a verifiable accepted security certificate, or without a qualified electronic certificate from a provider recognized by Türkiye.

The replacement option allows a manufacturer-authorized importer representative to upload the manufacturer's document with an importer undertaking bearing a secure e-signature based on a qualified electronic certificate from a provider recognized by Türkiye. The announcement also adds this option to Articles 8(1) and 8(3) for EU/EC certificates.

The other submission options remain in force. This is an alternative route with its own authorization, signature, and translation conditions, rather than a universal waiver of documentary formalities.

EK-2 authorization and the three-business-day response

Part I requires the foreign manufacturer to issue a Statement of e-Signature Authorization, using the EK-2 template, for each importer. One authorization cannot be shared across multiple importers.

The statement must identify the manufacturer, importer, authorized importer personnel, the manufacturer's verification contacts, the issue/signature date, and any authorization validity period. Manufacturer verification contacts must use official corporate email addresses. Only people who actively work for the importer and are active users of that company in ÜTS can act as authorized signatories.

The manufacturer must sign and seal or stamp EK-2. Where several manufacturer representatives are listed, at least one listed representative's signature and seal/stamp is sufficient. A seal or stamp is not required when the manufacturer signs the statement electronically.

TİTCK verifies the authorization through the manufacturer's corporate email contact. A reply is required within three business days. Otherwise, the authorization is not accepted as valid and the associated ÜTS document applications are rejected. Verification is normally performed once for an unchanged authorization, but Part I(4) preserves re-verification where necessary; it is not an unconditional permanent approval.

Under Part I(9), the manufacturer must promptly notify Utsbelgedogrulama@titck.gov.tr if a verified authorization is revoked or its duration changes. EK-2 appears on PDF page 8; EK-1, the importer undertaking, is on page 7.

Upload the right documents into the right fields

Parts II and III specify an interim workflow pending a dedicated authorization-document type in ÜTS. The two filing types use different field arrangements:

For both workflows, the EK-1 undertaking page must carry the authorized importer representative's secure e-signature. The announcement states that signing the undertaking within the submitted document is sufficient. The signatory must be named in EK-2; a valid electronic signature alone does not cure missing authorization.

Upload the original e-signed file so that its signature can be verified. A copy, changed format, or altered version that prevents verification is not acceptable. The sworn translation must include the translator's identity, authentication, and statement that it corresponds to the original; only the Turkish portion of the translator-approved document goes into the Turkish-document field.

For EK-2 itself, following the official English template removes the requirement for an additional sworn Turkish translation of that authorization. A different template or format requires the additional translation. This exemption does not remove the translation requirements for the underlying conformity document.

Invalid authorizations and the planned ÜTS module

Parts II and III state that unverified, erroneous, or incomplete authorizations can prevent acceptance of a registration/update application. If detected after the application process is complete, TİTCK will take action to drop the associated notification record. EK-1 separately records the importer's undertaking about the accuracy and completeness of the submitted copy.

Part IV says these interim provisions remain applicable until the technical changes and a new announcement. The planned module will create a dedicated e-signature authorization document type and automate checks on authorized personnel and validity periods. TİTCK says it will publish a further announcement, including transition arrangements, before the technical changes go live. The current announcement does not establish that the future module is already operating.

Practical preparation for manufacturers and importers

Pure Global analysis: Treat this as a coordinated manufacturer/importer filing process. Before the first upload, check EK-2 identities against the importer's active ÜTS users, confirm the corporate verification inbox is monitored, and assign responsibility for the three-business-day reply. Using the official EK-2 template can avoid an additional authorization-translation step.

The importer should verify the EK-1 signature and complete file before uploading; the manufacturer should retain a register of authorizations and changes to their duration. These controls follow directly from the rejection and record-cancellation risks in the announcement. They do not depend on the future automated module or assume that every electronic-signature platform satisfies the new option.