Türkiye'de Tıbbi Cihaz Kayıt Sisteminin Değerlendirilmesi

Abstract

The medical device industry is a sector that includes a wide variety of product groups and technologies, from syringes to tomography devices, bioinformatics or engineering product cells. Especially in a globalized world and in Turkey with the principle of free movement of goods along with the customs union agreement to secure access to products in the medical device market has been the most basic need. Registering medical devices is the first and most important step in providing access to safe products. This study is an cross-sectional study aiming to determine how the medical device registration system is recognized in the dimensions of the software, registration process, and access to the market with the perspective of the manufacturer or importer of medical device companies that are in the position of the user and the Turkish Medicine and Medical Device Agency (TMMDA) medical devices office workers. The data was collected by survey which consists of 4 sections and 43 questions. In the study, the data obtained from 450 persons, consisting of the medical device firm and TMMDA medical device employees, were evaluated. As a result of the analyzes, an independent sample t-test was applied to compare the system evaluation averages according to the institution the participants were working with. According to this test result; it was found that in 29 out of 32 question expressions there is statistically significant difference between the evaluation levels of the participants who worked in the medical device company and TMMDA employees, (p <0,05). It was determined that there was a statistically significant difference between the medical device companies and the employees of TMMDA, both in general scale (-8,074; p = 0,000: p <0,05) and in all sub-dimension averages. As a result, it has been determined that the views of the medical device company employees and TMMDA medical device employees regarding the software, process and market access dimensions of the medical device registration system are different and their opinions are different in terms of approach to the system. In order to overcome these differences, TMMDA should complete the legislative work specific to the medical device registration system, clarify the registration examination criteria and duration. In addition, trainings should be organized for TMMDA specialists and studies should be carried out to bring employees closer to each other.