title: A medical device regulatory framework - case study: South Africa.
abstract: 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.
authors.affiliation: Healthcare Technology Management at University of Cape Town, South Africa. poluta@cormack.uct.ac.za
authors.forename: Mladen A
authors.initials: MA
authors.lastname: Poluta
mesh_terms: D018795:Device Approval / Q000592:standards*; D004389:Durable Medical Equipment; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies; D019317:Evidence-Based Medicine; D014943:Global Health; D006801:Humans; D017146:Models, Organizational; D011358:Product Surveillance, Postmarketing; D013019:South Africa