E-Signed Document Acceptance in UTS Registration: Key Requirements & Guidelines

The Turkish Pharmaceuticals and Medical Devices Authority (TITCK) continues to modernize and digitize the Product Tracking System (UTS) registration and notification processes for medical devices. According to the updated Guideline on Medical Device Registration Processes in the Product Tracking System, specific requirements have been established for accepting electronically digital signed (e-signed) documents and certificates.

To avoid application rejections, prevent delays in your market access, and streamline your digital submissions, here are the essential requirements you need to know regarding e-signed document submissions.

1. Mandatory Upload of Original E-Signed Documents

For certificates (such as EC Certificates, MDR/IVDR EU Certificates) issued and signed electronically by Notified Bodies, the original digital e-signed file must be uploaded to ÜTS.

• Verification Requirement: The digital signature of the authorized signatory must be verifiable through official signature validation tools/data.
• Scanned Copies Are Not Accepted: Printing an e-signed document and uploading a scanned copy (PDF or image format) voids its electronic signature validity and will be rejected.

2. Automatic Rejection for Unverifiable E-Signatures

In accordance with TITCK guidelines, submissions will be strictly rejected if:

• The original e-signed file is not uploaded,
• The electronic signature cannot be verified during the validation check,
• The document contains an invalid or expired electronic signature.

3. Official Portal & EUDAMED Verification Options

When a certificate is published and verifiable in full on the official portal of the issuing Notified Body or on EUDAMED:

• If E-Signed: The original e-signed file must be uploaded in compliance with signature verification rules.
• If Not E-Signed: Apostilled copy must be completely uploaded along with all relevant annexes.

4. Sworn Turkish Translation & Declaration Rules

Once the certificate is uploaded to the “Original Document” field, its Turkish translation—prepared by a sworn translator—must be uploaded to the “Turkish Document” field:

• Only the Turkish section of the sworn translated document should be uploaded to the “Turkish Document” field.
• The translation must clearly include the sworn translator’s name, surname, stamp/signature, and an official declaration stating that the translation accurately reflects the original document.

For detailed regulatory guidelines, you can visit the official MoH TITCK page!

You can download the full official guide here:

Expert Support for Your Medical Device & UTS Compliance

Navigating regulatory updates and ÜTS submission requirements in Turkey requires precision. Submitting incomplete or incorrect document formats can lead to costly delays or rejections.

Whether you are a medical device manufacturer or importer, contact our team today for end-to-end consulting on UTS registrations, e-signature validation, and Health Market Access in Turkey!

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