A COMPARATIVE STUDY OF MEDICAL DEVICES AND THEIR REGULATIONS IN US, EU, INDIA, AND CHINA
DOI:
https://doi.org/10.22159/ajpcr.2023.v16i3.46624Keywords:
MDR, MDD, Pre-market notification, NB, CE markingAbstract
The usage of medical device is on the rise due to the rise in incidence rate of chronic diseases, irregular health check-ups, and sedentary lifestyles and also rising cases of obesity, diabetes, neuro-based disorders, heart diseases, and chronic diseases relating to lifestyle disorders. Availability of hassle free home monitoring medical devices that can be used even by patients with no knowledge about the technical aspects made their way into patient homes. Even in the presence of restraining factors such as high cost and reimbursement issues, the opportunities for medical device professionals lie in the technological advancements and usage of internet of medical things in modern healthcare and the latest trend toward developing smart medical devices with fast development in (AI) and (ML). The usage of medical devices is on the rise due to medical device development is undergoing a huge technological advancement due to emergence 3D printing which allows development of devices designed specifically as per patient requirements. Medical devices like freestyle liber system by Abbott laboratories eliminate need for routine finger pricking as it has sensor that measures and records glucose levels through clothing of the consumer. Quickie Q300 M mini Wheelchair fits even in tight doorways, navigates restaurants, that are crowded and also in difficult living spaces. Harmonization of medical devices registration across the markets is essential to paue way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance. This review involves a comparative study of medical device regulations in four regions (US, EU, India and China).
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