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Applied Drug Research, Clinical Trials and Regulatory Affairs

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ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

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Review Article

Comparative Study on Law Relating to Orthopedic Implants in India, the United States and European Union with Case Study

Author(s): Lohithasu Duppala* and Kolapalli Venkata Ramana Murthy

Volume 8, Issue 2, 2021

Published on: 27 April, 2021

Article ID: e270421193047 Pages: 13

DOI: 10.2174/2213476X07666210427105549

Price: $65

Abstract

Background: The article provides a brief discussion on the comparative regulations on orthopedic implants in India, the United States, and European Union. Orthopedic implants are type of high-risk medical devices manufactured to substitute or replace a missing or damaged joint or bone or to support a damaged bone or joint and to improve the quality of life of patients. Thus, there is a need to regulate the import, manufacture, clinical investigation, sale, and distribution of orthopedic implants to ensure that all orthopedic implants that were brought to market are safe quality and performance. The orthopedic implants industry is adversely affected by a lack of awareness of proper regulatory practices, lack of awareness of the current regulatory practices, separate consistent standards, separate lawful requirements, and proper guidance on the quality system, etc.

Conclusion: The objective of this article is to harmonize the regulatory requirements at par with the internationally accepted regulations and to develop an ecosystem in the country to boost the Indian orthopedic device sector, and that will make India more productive for orthopedic device development to encourage national and multinational orthopedic implants industries to manufacture their orthopedic implants in India.

Keywords: Orthopedic implants, case study, regulatory practices, India, United States and EU, biological response

Graphical Abstract

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