Africa
The article describes in detail the application process to be followed concerning changes to legally marketed medical devices. Table of Contents The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of healthcare...
Africa
The new article describes in detail the aspects related to changes to the software used in medical devices, as well as materials and labeling. Table of Contents The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere...
Africa
The present article describes in detail the decision-making process to be followed when determining the regulatory nature of the changes and further steps to be taken. In particular, the document addresses the aspects related to the changes to the design of a medical...
Africa
The new article provides additional details regarding un-permissible changes to medical devices as set forth under the applicable legislation and also outlines the key points related to the change type assessment decision trees. Table of Contents The Tanzania...
Africa
The new article provides additional details regarding the types of changes to medical devices, their features, and the regulatory approach to be applied. Table of Contents Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the...
Africa
The article provides an overview of the regulatory requirements related to changes to medical devices already placed on the market. Table of Contents The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of...
