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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY |
| Authors Name: | Tulshidas Ramdas Maske , Dr. Nilesh Ware |
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IJNRD_188859
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| Published Paper Id: | IJNRD2303277 |
| Published In: | Volume 8 Issue 3, March-2023 |
| DOI: | |
| Abstract: | 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. |
| Keywords: | Regulatory affairs, FDA, MDR, EU MDR, CDSCO, CE Marking, Patient safety, Good Regulatory Practices |
| Cite Article: | "THE COMPARISON OF MEDICAL DEVICE REGULATIONS IN INDIA WITH USA, EU: AN QUALITATIVE STUDY ", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 3, page no.c685-c694, March-2023, Available :http://www.ijnrd.org/papers/IJNRD2303277.pdf |
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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 |
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Published Paper ID:IJNRD2303277 Registration ID: 188859 Published In: Volume 8 Issue 3, March-2023 DOI (Digital Object Identifier): Page No: c685-c694 Country: Girinagar, Pune, Maharashtra, India Research Area: Bio Medical Engineering Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2303277 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2303277 |
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
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