New Electronic Application System for Medical Device Clinical Trials

Dear Researchers and Business Partners,

Within the scope of the recent announcement published by the Turkish Medicines and Medical Devices Agency (TİTCK), an important digital transformation is taking place in the application processes for medical device clinical trials. As our Centre, we would like to inform you about this important change.

What Does the New System Bring?

TİTCK is launching two new electronic application modules as of 1 January 2025:

– Medical Device Clinical Trials Application Module

– In-Vitro Performance Studies Application Module

Who does it apply to?

New electronic submission system in particular:

– New commercial company-sponsored clinical trials

– It will be valid for the first applications to be made after 1 January 2025.

How will the system work?

– Applications will be made fully electronically

– No physical submission of documents will be required

– The originals of the documents will be kept by the applicant and presented to the organisation upon request

Status for Current Research

Relevant for trials approved before 1 January 2025:

– Change notifications

– Other applications will continue to be made through the existing system using the ‘Add General Document Application’ section.

As IUE Medical Point Hospital Prof. Dr. Ahmet Uğur Yılmaz Clinical Research Centre, we believe that this digital transformation will make our clinical research processes more efficient.

Source:

https://www.titck.gov.tr/duyuru/tcokka-tibbi-cihaz-klinik-arastirmalari-ve-in-vitro-performans-calismalari-basvuru-modulleri-31122024160344