South Africa’s Universal Health Coverage Will Benefit Devicemakers

South Africa’s Department of Health released its plan for a national universal healthcare system that will affect how medical devices are reimbursed. Devicemakers also are expected to benefit from the scheme as new regional clinics are built and medical equipment is purchased. Read More

South Africa New Device Regs Are Now Live

As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics. Read More

South Africa’s MCC Issues Draft Guideline on Quality Manuals

South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Read More

South Africa Releases Draft Regs for Drug-to-Device Transfers

South Africa’s health department released draft regulations for general medicine that include new procedures for transferring a drug registration to a medical device registration. Read More

Kenya’s Nairobi County to Buy More LuViva Devices From Guided

Guided Therapeutics is planning to sell five LuViva advanced cervical scans to the Nairobi County Health Services Sector in Kenya for use in the agency’s cancer screening program. Read More

Tanzania: All Devices Subject to Registration Rules in 2016

Tanzanian health regulators are reminding stakeholders that the second phase of registration for medical devices starts in less than three months. Read More

South African Regulators Seek Feedback on Device, IVD Guidelines

South African health authorities unveil guidelines on devices for comment. Read More

In 2014, the Focus Was All on Regulatory Reform, Quality and Transparency

2014 was a year of major strides in streamlining regulatory processes around the globe. Read More

Industry Mulls South African Government’s Latest Attempt to Regulate Medical Devices

South Africa is taking another stab at regulating medical devices and in vitro diagnostic products, this time via a regulation that would bring them under the purview of the Medicines Control Council. Read More

South Africa Is Stepping Up as Major Source for Isotope

Volcanic eruptions, reactor shutdowns and a push for low-enriched uranium (LEU) have combined to make South Africa a leading source for a widely used diagnostic isotope. Read More