Australia and Oceania The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
Africa The article describes in detail the regulatory requirements related to the procedure of medical device establishment license renewal in South Africa based on the respective documents. Table of Contents The South African Health Products...
Ethiopia The article provides an overview of the guidelines issued by the Ethiopian authority concerning the way medical devices should be placed on the market. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the...
FDA The present article describes the aspects related to material characterization, removing manufacturing material residues, and sterilization. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
Ethiopia The second article addresses certain specific matters related to periodic management reviews, complaints handling, and also the actions to be taken for returned medical devices. Table of Contents The Ethiopian Food and Drug Authority (EFDA), a country’s...
