THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY

Tulshidas Ramdas Maske , Dr. Nilesh Ware

Regulatory affairs, FDA, MDR, EU MDR, CDSCO, CE Marking, Patient safety, Good Regulatory Practices

Safe, effective, and of high-quality medical devices are necessary for a well-functioning healthcare system. By 2025, The market for medical devices worldwide is anticipated to be worth $797 billion [1]. In the medical regime, the effectiveness and safety of medical equipment are crucial factors. The authorization process is intricate, multistep, region-specific, and requires assessment by notified bodies. The notified bodies approve marketing licensing/authorization after critically investigating the technical documentation submitted by the Manufacturer. For quality patient care, there needs to be a balance between innovation and regulations. Manufacturers must submit an application for marketing authorization to the US Food and Drug Administration (USFDA) in the USA [2]. National notified bodies, EMA, and RA of member states must all approve the marketing of medical devices in the European Union[3]. Medical device manufacturing, import, and sales in India are authorized by the Drug Controller General of India (DCGI), a central licensing authority (CLA) under the Central Drugs Standard Control Organization (CDSCO). This paper aims to review medical device regulations in these three nations, namely the USA, the EU, and India, and to compare regulatory requirements across these three areas as well as their potential influence on innovation market.

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"THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY ", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.8, Issue 3, page no.c685-c694, March-2023, Available :https://ijnrd.org/papers/IJNRD2303277.pdf

Volume 8 Issue 3, March-2023

Pages : c685-c694

Paper Reg. ID: IJNRD_188859

Published Paper Id: IJNRD2303277

Downloads: 000118876

Research Area: Bio Medical Engineering 

Country: Girinagar, Pune, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2303277

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2303277

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJNRD (IJ Publication) Janvi Wave

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