herdem

With advancement of technology, software has rapidly become an essential part of human daily life and became an important part of healthcare products serving both medical and non-medical purposes. With this respect, use of software as a medical device (“SaMD”), which is on its own a medical device, is continuing to increase, and the subject is being addressed by global actors.

Governments allocate large budgets to maintain and strengthen their security capabilities whilst defense manufacturers explore new markets continuously to expand their sales in this heavily regulated industry.

Türkiye'de COVID-19'a karşı alınan önlemler kapsamında Sivil Havacılık Genel Müdürlüğü ("SHGM") tarafından uçakların yolcu kabininde kargo taşınmasına ilişkin UOD-2020/2G Genelgesi'nin ("Genelge") 2. revizyonu 29 Nisan 2020 tarihinde yayımlandı. Genelgenin amacı, tıbbi malzemelerin uluslararası alanda taşınmasını sağlamak ve kargo taşımacılığına ilişkin olarak Türkiye pazarını korumaktır.

As per the Presidential Decree No. 2480 published in the Official Gazette No. 31114 dated April 30, 2020, judiciary period suspension stipulated under provisional article 1 of the Law Amending Certain Acts No.7226 published in the Official Gazette No. 31080 dated March 26, 2020 is temporarily extended with the exception of the mandatory administrative application periods stipulated under Public Procurement Law No. 4734, due to the Covid-19.

As per the new announcement published by the Turkish Medicines And Medical Devices Agency (“the Agency”), the previously published announcements on the pre-authorization application processes regarding the certain export prohibited products  have been updated and as of April 27, 2020, the applications to be made to the Agency shall continue in accordance with the new guide attached to the announcement.

A new e-filing system has been established for complaints through Turkish Public Procurement Authority’s (“Procurement Authority”) Electronic Public Procurement Platform (“EKAP”). The launch of the e-filing aims to prevent the loss of rights resulted from procedural mistakes in in-person/in mail applications. In the announcement published on the official website of the Procurement Authority on April 29, 2020, it was stated that a training video and guidelines were published regarding the process.