Comparative Study between USFDA Medical Devices and CDSCO Medical Devices

Beram Saranya Sukantha*, Yarra Sai Phanindra, Kotipalli Jyothirmaye, Doonaboyina Ragava, Kavala Nageswara Rao
Department of Pharmaceutical Drug Regulatory Affairs, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

Abstract
Medical devices are an important aspect of healthcare as they help diagnose, monitor, and treat a wide range of medical conditions. These devices include everything from simple devices like tongue depressors and bandages to complex imaging machines and hi-tech surgical robots. 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. Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Medical devices market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion and is expected to reach $50 billion by 2025. 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. In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. To fulfil this gap, Central Drug Standard Control Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. 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devices registration across the markets is essential to pause way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.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). The Medical Device Regulations are different in these countries, but PMA & Post market process is done for the marketing of Quality products. In US two third of the medical devices which are approved through the less rigorous 510 (k) process is recalled due to major harm/ death caused to the patient. I conclude that till, 2017 there was no such strict regulations for medical devices manufacturing, import and sale. From, 1stJanuary 2018, new regulations were implemented by Indian ministry of health and family welfare (MoHFW). The Indian government’s recent decision to permit 100% FDI in the outsourcing of medical devices will greatly improve the prospects for the sector . High tax rates imposed on domestic manufacturers have made investment unappealing to some foreign companies, especially given the comparatively low amount of tax levied on imported medical goods. It is therefore hardly surprising that foreign firms often choose to access India’s medical market without establishing a direct presence, many companies establish factories in neighbouring countries and export devices.
Keywords: Ministry of Health and family welfare (MoHFW), Centre for Devices and Radiological Health (CDRH), Central Drug Standard Control Organisation (CDSCO), Drug Controller General Of India (DCGI).