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

Author:

Saini Garima1ORCID,Choudhary Manjusha2ORCID,Budhwar Vikas1,Hussain Tarif1ORCID

Affiliation:

1. Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India

2. Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, 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.

Publisher

SAGE Publications

Subject

Pharmaceutical Science

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