Medical devices: product safety and product liability issues

The paper aims to provide an overview of the potential liability of a manufacturer or distributor or other persons in the chain of product distribution for supplying unsafe or substandard medical devices and for any damage caused by a defect in the device. Just like other products, medical devices a...

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Main Author: Amin, Naemah
Format: Conference or Workshop Item
Language:English
English
Published: 2015
Subjects:
Online Access:http://irep.iium.edu.my/44239/
http://irep.iium.edu.my/44239/3/cert.pdf
http://irep.iium.edu.my/44239/1/Dr.Naemah_-_medical_devices.pdf
id iium-44239
recordtype eprints
spelling iium-442392015-08-19T02:40:08Z http://irep.iium.edu.my/44239/ Medical devices: product safety and product liability issues Amin, Naemah K Law (General) The paper aims to provide an overview of the potential liability of a manufacturer or distributor or other persons in the chain of product distribution for supplying unsafe or substandard medical devices and for any damage caused by a defect in the device. Just like other products, medical devices are also subject to the law of product safety and product liability. The discussion on product safety focuses on the requirements of medical device safety under the Medical Device Act 2012 and criminal liability of the manufacturer, importer and distributor including the hospitals and doctors for non-compliance with the law. They may also subject to civil claims by patients under various product liability laws – contract, negligence and Part V and Part X of the Consumer Protection Act 1999. It is thus important for medical practitioners to have a clear understanding of these laws to avoid contravention and legal proceedings. 2015-05-24 Conference or Workshop Item NonPeerReviewed application/pdf en http://irep.iium.edu.my/44239/3/cert.pdf application/pdf en http://irep.iium.edu.my/44239/1/Dr.Naemah_-_medical_devices.pdf Amin, Naemah (2015) Medical devices: product safety and product liability issues. In: MLSM Regional Medico-legal Conference 2015, 23rd-24th May 2015, The Royale Chulan, Kuala Lumpur. (Unpublished)
repository_type Digital Repository
institution_category Local University
institution International Islamic University Malaysia
building IIUM Repository
collection Online Access
language English
English
topic K Law (General)
spellingShingle K Law (General)
Amin, Naemah
Medical devices: product safety and product liability issues
description The paper aims to provide an overview of the potential liability of a manufacturer or distributor or other persons in the chain of product distribution for supplying unsafe or substandard medical devices and for any damage caused by a defect in the device. Just like other products, medical devices are also subject to the law of product safety and product liability. The discussion on product safety focuses on the requirements of medical device safety under the Medical Device Act 2012 and criminal liability of the manufacturer, importer and distributor including the hospitals and doctors for non-compliance with the law. They may also subject to civil claims by patients under various product liability laws – contract, negligence and Part V and Part X of the Consumer Protection Act 1999. It is thus important for medical practitioners to have a clear understanding of these laws to avoid contravention and legal proceedings.
format Conference or Workshop Item
author Amin, Naemah
author_facet Amin, Naemah
author_sort Amin, Naemah
title Medical devices: product safety and product liability issues
title_short Medical devices: product safety and product liability issues
title_full Medical devices: product safety and product liability issues
title_fullStr Medical devices: product safety and product liability issues
title_full_unstemmed Medical devices: product safety and product liability issues
title_sort medical devices: product safety and product liability issues
publishDate 2015
url http://irep.iium.edu.my/44239/
http://irep.iium.edu.my/44239/3/cert.pdf
http://irep.iium.edu.my/44239/1/Dr.Naemah_-_medical_devices.pdf
first_indexed 2023-09-18T21:02:55Z
last_indexed 2023-09-18T21:02:55Z
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