SciELO - Scientific Electronic Library Online

 
vol.108 issue3Regulating the South African sport supplement industry: 'Whey' overdueMaternal near-miss audit in the Metro West maternity service, Cape Town, South Africa: A retrospective observational study author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand

Article

Indicators

Related links

  • On index processCited by Google
  • On index processSimilars in Google

Share


SAMJ: South African Medical Journal

On-line version ISSN 2078-5135
Print version ISSN 0256-9574

Abstract

SAIDI, T  and  DOUGLAS, T S. Medical device regulation in South Africa: The Medicines and Related Substances Amendment Act 14 of 2015. SAMJ, S. Afr. med. j. [online]. 2018, vol.108, n.3, pp.168-170. ISSN 2078-5135.  http://dx.doi.org/10.7196/samj.2018.v108i3.12820.

The Medicines and Related Substances Amendment Act 14 of 2015 has brought significant changes in the regulation of medical devices in South Africa (SA). The highlights include the establishment of a regulatory authority - the SA Health Products Regulatory Authority - the introduction of a tier-based licensing and registration system, and the restriction of bonusing and sampling for the sale of medical devices. The enactment of the new regulations is a positive development for the SA medical device industry. However, the impact depends on the implementation of these regulations. Conditions that will support the success of the regulations include creating a critical mass of skilled personnel and measures that ensure timely registration. SA can learn from the experiences and practices of other countries that have introduced medical device regulations in recent years.

        · text in English     · English ( pdf )

 

Creative Commons License All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License