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dag56 replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 5 months ago
After doing some research, I chose to pick an area where design controls were not in place. Within the African continent, only 7% of the 46 sub-Saharan countries had a regulatory policy, National Medicines Regulatory Authorities (NMRA), in place (2005). The rest of the countries in the continent have either minimal regulatory policy in place (estimated at 63%) and the remaining 30% had no design control regulations whatsoever. However a number of organizations have since been established to encourage a normalization of policy throughout the continent. These include: African Organization for Standardization (ARSO), The African Network for Drugs and Diagnostic Innovation (ANDI), African Union (AU) and United Nations Economic Commission for Africa (UNECA).
More recently, as of June 1st 2017, the South Africa established its first regulatory system for medical devices and in vitro diagnostics. The new independent state-owned regulatory entity is called the South African Health Products Regulatory Authority (SAHPRA) and will regulate both drugs and devices.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221680/
http://www.fdanews.com/articles/182314-south-africa-new-device-regs-are-now-live
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326589/