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Regulatory Obligation and Challenges faced by the medical device manufacturer in Europe, United States & India
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| Author:
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SHERMILAN P A, DR.RAJU KAMARAJ
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| Abstract:
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The regulatory obligation and challenges faced by the medical device manufacturer in EMA, FDA and CDSCO. The medical device manufacturer have described the regulatory requirement of the distributors, importers, and quality management system. The regulatory bodies of Europe, USA and India are elaborated as common framework for regulations in the stages, premarket, placing on market and post market. The devices are classified in different class risks and also explained about the global market size of the medical device industry. And challenges problem faced by the medical device manufacturer as evaluated by major problem defects of the regulatory issues for the manufacturer as reported in the regulatory authorities and compliances are noted in the company profiles. The guidelines are expanded by the regulatory bodies. The established USFDA guidelines in 1976 by 1938 FDA act medical device amendments, the council of European Union of the medical device in 1973, the government of India CDSCO has regulated by the (CLAA) central license approval authority.
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| Keyword:
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Medical Device, Regulatory Obligations, Challenges, CDSCO, USFDA, EMA.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.376
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| Download:
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Request For Article
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