ABSTRACT

Medical device is a significant component of patient treatment. So, it requires effective regulation for manufacturing, sell and distribution. The design, development, and marketing of advanced medical technology are greatly affected by the medical device regulations. So, the foundation of successful medical device innovation is a thorough understanding of the numerous regulatory requirements and their practical application. Throughout the past twenty years, there has been a significant increase in the quantity, variety, and complexity of medical equipment. The need for a stable regulatory perspective has led to advancements in the regulation of these devices as well. In this research paper, we conduct survey in different sectors of pharmacy such as students and industries. This is completely questionnaire based online survey on regulation of medical device in India and USA, circulated via google form to different professions (students and industry) through email and several social media platforms, including WhatsApp, Telegram, etc. We analysed the received responses and the received responses defines knowledge of regulation of medical device. The study finds that professionals in the industry are better knowledgeable about medical device regulation than students, which necessitates the inclusion of more sources for students in order to give them more readily understood knowledge in the future. Keywords: Medical device, Survey, CDSCO, USFDA, Regulation
Publication date: 01/02/2024

https://ijbpas.com/pdf/2024/February/MS_IJBPAS_2024_7775.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.2.7775