The comparative study on performance of selected medical devices manufactured in india and foreign countries with regulatory aspects

Abstract

quotBackground: Medical devices are the integral part of modern medical industry. The dependency of medical device has increased handsomely in treatment of diseases. This dependency has led to quality issues in medical care resulting in complications in the condition of the patients as the body does not accept them and consider them as foreign body. Therefore, for manufacturing of medical device safety and quality are given prime importance in its regulation. Initially the regulation around the world was evolving and now by introducing guidelines and policies and the revision of law has provided satisfactory guidance for the manufacturers and agencies to manufacture and check the quality appropriately. The regulation will implement the safe manufacturing, quality, and uniformity of medical devices throughout and it will also ease the importing procedures into India. The guidelines implemented and regulated effectively will have a positive outcome. newlineAim: The objective of the present study is comparison of regulatory guidelines for medical devices in India and US and European Union newlineMaterial and Methods: The research work involves study of Medical regulation of US, EU and its comparison with Indian regulation by conducting study of different class of medical devices. Data collected was analyzed for device problems and complications. The data for reporting of issues was further checked with regulatory websites of India and other countries. newlineResults and Discussion: In the study four medical devices from different classes (Class A, Class B, Class C and Class D were selected and the study was conducted in various hospitals of four towns in Gujarat. The hospitals were government and private hospitals. A total of 2323 cases were studied from four cities. Maximum numbers of patients were of urinary catheter and IV cannula. Government hospital showed more number of patients compared to private hospitals. The primary reason was the treatment in Government hospital is cheaper than private hospitals and various medical schemes of In