Regulatory approaches: Global medical device tracking advancement in USA, EU and India

Abstract

Advancement in science & technology of medical industry is coming up with innovations. Medical devices play a vital role. Real Time Location System (RTLS) which includes Radio Frequency Identification (RFID) device, Wi-Fi technology that helps to look after adverse events and recall products when required, thereby, prevent theft by keeping regular check on their movement with location sensors. In 19th century two products of United States faced product withdrawal. After that, US felt the need to develop system for product record management and tracking. In 2004, FDA introduced Unique Device Identifier (UDI) for medical device tracking. With time, GHTF came up with UDI working groups and in 2013, new version of UDI guidelines for globally harmonized use was generated. In this article study about various countries has been done. It was found that countries like United States and Europe have introduced medical device tracking system and by 2022 this will be implemented in India.