Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 168-170 |
| Number of pages | 3 |
| Journal | SAMJ : South African Medical Journal |
| Volume | 108 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 2018 |
| Externally published | Yes |
Funding
This work is based on research supported by the SA Research Chairs Initiative of the Department of Science and Technology and the National Research Foundation of SA (grant no. 98788). Author contributions. TS and TD conceived and designed the study. TS drafted and TD edited the manuscript. Both authors participated in the analysis of the literature and approval of the final article. Funding. This work is based on research supported by the SA Research Chairs Initiative of the Department of Science and Technology and the National Research Foundation of SA (grant no. 98788). Conflicts of interest. None.
| Funders | Funder number |
|---|---|
| SA Research Chairs Initiative | |
| National Research Foundation | 98788 |
| National Research Foundation Singapore | |
| Department of Science and Technology, Ministry of Science and Technology, India |
