FDA The new article addresses the aspects related to the factors for Safer Technologies Program (STeP) entrance and review process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Ethiopia The article provides an overview of the regulatory requirements for medical device labeling introduced in Ethiopia. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare...
FDA The article provides an in-depth review of the regulatory requirements for facet screw systems. Table of Contents The Food and Drug Administration (FDA or the Agency), has published a guidance document dedicated to the performance...
Asia The article provides an overview of the regulatory requirements related to change notification for medical devices that are already placed on the market. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency...
FDA The new article describes in detail the core principles of the Safer Technologies Program introduced by the FDA to improve the regulatory framework for certain types of medical devices. Table of Contents The Food and Drug...
Africa The article provides an overview of the Kenyan regulatory requirements in the sphere of post-market surveillance for healthcare products. Table of Contents The Pharmacy and Poison Board, a division of the Kenyan Ministry of Health,...
