Comprehensive Regulatory Framework in Current Advancements of Medical Devices

Abstract

Background: A medical device is any tool, implant, or IVD that is intended to manage, ameliorate, avert, or identify a human disease. Simple thermometers, bandages, implants, and so on are examples. A medical device’s primary intended use is not accomplished chemically on or within the skin, nor does it require metabolization to accomplish that primary intended use. Medical devices are classified differently by different regulatory bodies. The FDA divides medical devices into three categories, whereas India and Europe divide them into four categories based on risk. Each regulated country has its own set of medical device regulations and guidelines. Purpose: The medical device sector is expected to showcase a remarkable journey of growth by 2029, achieving a 718.92-billion-dollar market with a CAGR of 5.5% over the expansion period of 2022–2029, making it the fastest-growing global market. The earlier medical device has simple inspection and testing but Post Covid19 due to an increase in imports, takeover from foreign manufacturers, and fostering innovation medical devices took off, becoming ever more sophisticated and widely available therefore the need for manufacturing and product standards was recognized, the new regulation was framed and regulatory specialists were recruited. Thereby led to the emergence of a whole new regulatory system and a post-marketing surveillance strategy. Methods: The analysis of current market size, share, and trends on medical devices for USA, Europe, and India was performed and current regulatory standards were observed which are continuously becoming stringent for all the countries with the advancement of technology. Conclusions: The Medical devices sector is the leading growing market. With the advancement in the medical device sector such as cybersecurity, digitalization, data privacy, and innovation, new entrants and new manufacturers the doors for entrepreneurship will open thus, it becomes highly important and necessary to introduce comprehensive regulatory guidelines for safety, effectiveness and customer protection, and satisfaction. The regulated medical devices sector will reach new heights with stringent vigilance and transparency benefitting society.