Saidi T, Douglas T S
Division of Biomedical Engineering, Department of Human Biology, University of Cape Town, South Africa.
S Afr Med J. 2018 Feb 27;108(3):168-170. doi: 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. 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.
2015年第14号《药品及相关物质修正法案》给南非医疗器械监管带来了重大变革。亮点包括设立了监管机构——南非卫生产品监管局，引入了基于层级的许可和注册制度，以及限制医疗器械销售中的回扣和抽样行为。新法规的颁布对南非医疗器械行业来说是一个积极的发展。然而，法规的影响将取决于实施情况。有助于法规成功实施的条件包括培养足够数量的专业人才以及采取确保及时注册的措施。南非可以借鉴近年来出台医疗器械法规的其他国家的经验和做法。
