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Articles Published Processes
12/17/2024 9:21:49 AM | Browse: 86 | Download: 272
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Received |
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2024-07-28 17:18 |
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Peer-Review Started |
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2024-07-28 17:18 |
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First Decision by Editorial Office Director |
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2024-09-25 09:54 |
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Return for Revision |
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2024-09-25 09:54 |
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Revised |
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2024-10-08 18:10 |
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Publication Fee Transferred |
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2024-11-13 11:02 |
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Second Decision by Editor |
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2024-11-12 02:37 |
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Second Decision by Editor-in-Chief |
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Final Decision by Editorial Office Director |
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2024-11-12 09:38 |
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Articles in Press |
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2024-11-12 09:38 |
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Edit the Manuscript by Language Editor |
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Typeset the Manuscript |
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2024-11-25 10:48 |
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Publish the Manuscript Online |
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2024-12-17 09:21 |
| ISSN |
2218-5836 (online) |
| Open Access |
This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/ |
| Copyright |
© The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved. |
| Article Reprints |
For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
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| Permissions |
For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
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| Publisher |
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA |
| Website |
http://www.wjgnet.com |
| Category |
Orthopedics |
| Manuscript Type |
Minireviews |
| Article Title |
Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants
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| Manuscript Source |
Unsolicited Manuscript |
| All Author List |
Vidya Menon |
| ORCID |
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| Funding Agency and Grant Number |
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| Corresponding Author |
Vidya Menon, Assistant Professor, PhD, Law, Gujarat National Law University, Koba, Gandhinagar, Ahmedabad 382426, Gujarāt, India. vidyaphd202055@gnlu.ac.in |
| Key Words |
Johnson & Johnson faulty hip implants; DePuy articular surface replacement hip implants; Medical devices rules 2017; Materiovigilance program of India; Medical device adverse events; Indian medical device regulatory regime |
| Core Tip |
This study provides a comprehensive examination of regulatory inadequacies within India’s medical device sector, focusing exclusively on the Johnson & Johnson hip implant case. It identifies critical deficiencies in the existing legislative framework, insufficient postmarket surveillance, and a lack of effective accountability mechanisms, all of which pose substantial risks to patient safety. The findings underscore the urgent need for systematic reforms, including the implementation of mandatory clinical investigations, the establishment of centralized patient registries, and enhanced collaboration with international regulatory authorities. Addressing these regulatory gaps is imperative for safeguarding public health and restoring confidence in the medical device industry. |
| Publish Date |
2024-12-17 09:21 |
| Citation |
Menon V. Regulatory gaps in India’s medical device framework: The case of Johnson and Johnson’s faulty hip implants. World J Orthop 2024; 15(12): 1124-1134 |
| URL |
https://www.wjgnet.com/2218-5836/full/v15/i12/1124.htm |
| DOI |
https://dx.doi.org/10.5312/wjo.v15.i12.1124 |
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