ABSTRACT

Medical devices play a crucial role in diagnosing, treating, and preventing diseases, with their regulation being paramount to ensuring patient safety and device effectiveness. The FDA classifies medical devices into three categories based on their risks. Regulatory frameworks such as the FDA's Quality Management System Regulation (QMSR) and international standards like ISO 13485 ensure compliance with quality standards and regulations. A robust regulatory strategy involves understanding applicable laws, performing risk assessments, conducting clinical research, and engaging with regulatory bodies. Compliance with Good Manufacturing Practice (GMP) regulations is essential to maintaining product quality and safety. Continuous monitoring and post-market surveillance are critical for identifying and addressing potential risks associated with medical devices throughout their lifecycle. Harmonizing regulatory standards globally facilitates market access for medical devices, promoting innovation and patient access to novel technologies. Proactive evaluation and updating of regulatory processes are necessary to address emerging challenges and advancements in medical technology effectively. Overall, adherence to regulatory requirements, risk management practices, and continuousregulatory evaluation are essential for ensuring the safety, efficacy, and quality of medical devices, ultimately benefiting patients and healthcare professionals worldwide. Keywords: Medical Devices, Regulatory Strategies, FDA, Risk assessment, Regulatory evaluation, Technology advancements
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9562.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9562