A medical device regulatory framework - case study: South Africa.

The regulation of medical devices is well-established in industrialized countries, with increasing global standardization and harmonization. In developing and resource-poor countries, however, there is a much greater degree of variability and implementation. For such countries, this paper suggests a comprehensive and integrated regulatory framework approach using the South African health technology policy framework as a basis for comparison and benchmarking. It is hoped that this compact model, which covers a wide range of HTM-related aspects, will be useful to governments and their partners, amongst other role-players.