Regulatory Approaches to Medical Devices: A Comparison between the United States, European Union, and India

Deveshkumar Kothwala, Jeel Patel and Kalpesh Deore

International Journal of Scientific Research in Science and Technology, 2025, vol. 12, issue 4, 1018-1028

Abstract: Before Medical devices can be marketed, they must undergo a formal process known as marketing authorization. This is a basic regulatory requirement to make sure the devices are safe, effective, and of high quality. It is very important for keeping patients safe, products safe, and making commerce worldwide possible by following global regulations. As the MedTech industry grows around the world, manufacturers need to compare the rules in different areas to come up with effective and legal market strategies. This survey looks at the rules for medical devices in the US, the EU, and India. It focuses on how devices are classified, how they are approved, how they are tested in clinical trials, and how they are watched after they are sold. The U.S. FDA uses a centralized, risk-based approach, while the EU uses a decentralized model with Notified Bodies under the EU MDR 2017/745. This model focuses on clinical data and openness. The Medical Device Rules (2017) govern India's regulatory landscape. It is moving toward being more in line with international standards, but it still has problems with implementation and infrastructure. The Central Drugs Standard Control Organization (CDSCO) first used the CLAA regulatory scheme under the Cosmetics and Drugs Act to make sure that the licensing of some important medications and medical devices in India is the same across the board and is overseen by a central authority. The CLAA (Central Licensing Approval Authority) scheme is unique to India. It gives the Central Drugs Standard Control Organization (CDSCO) the power to issue licenses for higher-risk devices (Class C and D), making sure that there is central oversight. This comparison study finds important differences and points out chances to make regulations more consistent, work more efficiently, and make medical technologies more accessible around the world.

Keywords: Regulation of medical devices; Classification of devices; Approval before they hit the market; Surveillance after they hit the market; Regulation framework; Food and Drug Administration (U.S. Food and Drug Administration); EU MDR (European Union Medical Device Regulation); a CDSCO (Central Drugs Standard Control Organization) (search for similar items in EconPapers)
Date: 2025
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Persistent link: https://EconPapers.repec.org/RePEc:etm:ijsrst:v12:y2025:i4:id:1106

DOI: 10.32628/IJSRST251378

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