Testing Infrastructure Readiness for Electronic-Based Medical Devices in Indonesia

Penulis: Jimmy Abdel Kadar,Mohamad Tomtom Makmur,Ihsan Supono,Asep Rahmat Hidayat,Wuwus Ardiatna,Siddiq Wahyu Hidayat,Amelia Febri Ariani
The purpose of this study is to review the gap between the regulations and the supporting infrastructure that was formed and to propose strategies in developing a conformity assessment infrastructure as part of it. This activity uses descriptive qualitative methods through collecting indicators from regulations, the results of previous researches and collecting data through interviews and questionnaires from stakeholders. This activity is a preliminary study that outlines problems related to the development of the medical device industry in Indonesia, in terms of the adequacy of electronic-based medical device testing infrastructure. The results showed that the lack of infrastructure affecting the production to be constrained in their acceptance. Infant incubator has fulfilled all the criteria for readiness from planning to marketing, and even the supervision when it has been utilized as a service in health facilities. This also implies that the amount and scope of the testing infrastructure must be increased.

Medical Journal of Indonesia, 2020

No. Arsip : LIPI-20200120