Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015
The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The highlights include the establishment of a regulatory authority, the South African Health Products Regulatory Agency, the introduction of a tier-ba...
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doaj-bddc9501c446404ebb7aa554c5d428872020-11-24T21:16:54ZengHealth and Medical Publishing GroupSouth African Medical Journal0256-95742078-51352018-03-01108316817010.7196/SAMJ.2018.v108i3.12820Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015T SaidiT DouglasThe Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The highlights include the establishment of a regulatory authority, the South African Health Products Regulatory Agency, the introduction of a tier-based licensing and registration system, and restriction of bonusing and sampling in the sale of medical devices. The enactment of the new regulations is a positive development for the South African medical device industry. However, the impact of the regulations will depend on implementation. Conditions that will support the success of the regulations include creating a critical mass of skilled personnel and measures that ensure timely registration. South Africa can learn from the experiences and practices of other countries that have introduced medical device regulations in recent years.http://www.samj.org.za/index.php/samj/article/download/12221/8405 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
T Saidi T Douglas |
spellingShingle |
T Saidi T Douglas Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 South African Medical Journal |
author_facet |
T Saidi T Douglas |
author_sort |
T Saidi |
title |
Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 |
title_short |
Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 |
title_full |
Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 |
title_fullStr |
Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 |
title_full_unstemmed |
Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015 |
title_sort |
medical device regulation in south africa: the medicines and related substances amendment act 14 of 2015 |
publisher |
Health and Medical Publishing Group |
series |
South African Medical Journal |
issn |
0256-9574 2078-5135 |
publishDate |
2018-03-01 |
description |
The Medicines and Related Substances Amendment Act, 14 of 2015, has brought significant changes in the regulation of medical devices in South Africa. The highlights include the establishment of a regulatory authority, the South African Health Products Regulatory Agency, the introduction of a tier-based licensing and registration system, and restriction of bonusing and sampling in the sale of medical devices. The enactment of the new regulations is a positive development for the South African medical device industry. However, the impact of the regulations will depend on implementation. Conditions that will support the success of the regulations include creating a critical mass of skilled personnel and measures that ensure timely registration. South Africa can learn from the experiences and practices of other countries that have introduced medical device regulations in recent years. |
url |
http://www.samj.org.za/index.php/samj/article/download/12221/8405 |
work_keys_str_mv |
AT tsaidi medicaldeviceregulationinsouthafricathemedicinesandrelatedsubstancesamendmentact14of2015 AT tdouglas medicaldeviceregulationinsouthafricathemedicinesandrelatedsubstancesamendmentact14of2015 |
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