Abstract

OVERVIEW OF MEDICAL DEVICES AMENDMENTS 2017 IN INDIA WITH EMPHASIS ON IN-VITRO DIAGNOSTICS

Rahul Saini*, Sameen and Ankita Kumar

Abstract

In the last two decades, the Medical Devices Industry has undergone a transformation - from being a domestic-industry- dominated sector prior to 1991 to import-dependent sector, to being a non-regulated sector prior to 2006, to regulation of 15 notified devices, to the new Medical Device Rules announced in 2017. The government has taken various steps to ensure that the medical devices sector is considered as significant as the other sectors. The new set of regulatory practices aims to prepare India to meet the medical devices sector requirements such as safety of patients, capping of devices, availability of safe devices, strict clinical investigation protocols to increasing innovations, ease of doing business and meeting international requirements. This article provides a comprehensive review of the major high lights of medical devices bill 2017 with focus on medical devices and in vitro diagnostics, describing the major changes and various procedures from applying for certificate to manufacture medical devices to import.

Keywords: Medical Devices, Import Policy, Notified Bodies, Diagnostics Equipment, Japan, USA.