Medical devices and IVDs (collectively termed medical technology) used in the diagnosis and treatment of disease and disability, as well as offering improvements in quality of life in humans, are regulated in many countries or regions around the world. In an increasing number of countries, legislators and policy-makers are developing or revising national systems for the regulation of medical technology.
SAMED recognizes that regulations have an impact on the medical technology market and determine the access of patients and clinicians to medical technology. Regulations also determine the level of investment in research and development in innovative technologies, local manufacturing and the attractiveness of a market. Regulators have a duty of care to the South African health system to ensure a fair and efficient regulatory environment that supports access to innovative and needed technologies by patients. SAMED acknowledges the right of the South African government to implement measures regulating medical technology including measures governing those who design, manufacture, market, use and/or distribute medical technology in South Africa.
SAMED supports reasonable, appropriate and proportionate government policies intended to ensure the safety, performance, and quality of medical technology so that they may contribute to protecting and improving public health.