• SHAMEEMA
• Vinaya Antony
• Ajmala
• Fadhiya
• Najiya Faizal PT

Medical Device is is one of the fast growing market since today . Today billions of people depend on medical devices for diagnosis and treatment. So, these medical devices reaching to the hands should be safe and effective to protect the public health, hence strict guidelines must be brought to play to ensure the quality of the medical devices. Regulatory Affairs experts play a critical role in the medical device industry, particularly in ensuring compliance throughout the lifecycle of medical devices . They provide essential guidance and support to expedite development and delivery while maintaining adherence to regulations, ultimately ensuring the safety and effectiveness of these products worldwide. This is a valuable review in which an examination of the regulatory landscape and classification of medical devices in India is crucial for understanding how they're managed and ensuring compliance with local regulations. It’s essential for manufacturers, healthcare professionals, and regulators alike to stay informed about these aspects to ensure the safety and efficacy of medical devices in the Indian market.

Medical device, Regulatory affairs, Market trends, Challenges

"‘Navigating the Maze: An Overview of Regulatory Affairs in Medical Devices’", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.j5-j8, June-2024, Available :http://www.jetir.org/papers/JETIR2406902.pdf

"‘Navigating the Maze: An Overview of Regulatory Affairs in Medical Devices’", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppj5-j8, June-2024, Available at : http://www.jetir.org/papers/JETIR2406902.pdf