New Obligation for Registration of Medical Device Technical Service Providers and Related Technical Staff
Dicle Doğan and Fatma Sevde Tan, Gun + Partners
On 14 February 2019, the Medicines and Medical Devices Agency published Circular on the Registration of Medical Device Technical Service Providers and Related Technical Staff (Turkish language), numbered 2019/1. Pursuant to the Circular, medical device technical service providers subject to after-sales maintenance and repair are obliged to register on the Product Track and Trace System. The registries became operational on 1 March 2019. From 1 July 2019, healthcare service providers shall receive technical services only from the technical service providers registered to the system.
Additionally, the Medicines and Medical Devices Agency published Guidelines on the Implementation of the Circular (Turkish language). The Guidelines establish the registration procedures to be performed in accordance with the provisions of the Circular and show the steps to be taken for registration.
First published by Practical Law, 30.03.2019