Quality and Regulation Standards for Ventilator as Medical Devices in India

Abstract

The Drugs & Cosmetic act is meant to regularize safety & quality of medical devices, which is applied to all medical devices, implemented from 1st April 2020. Earlier 37 medical devices were regulated/ notified in India. The present study focuses on the devices which require regulations but still lack the quality check points for scrutiny from Central Drug standard control organization (CDSCO), Delhi. Furthermore, it aims to provide quality checklist  for two upcoming devices (Ventilator) which is neither categorized nor regulated by Central Drug standard control organization, Delhi. Since the medical devices aid in diagnosing, treatment and palliative care, it is essential to check the quality such that it matches with the International standards. Post covid-19 outbreak ventilators have come under surveillance and notified as medical devices. The present study monitors all parameters for regulation of the ventilator. The survey based quality & regulation standards for ventilator as medical devices has been incorporated in this study.