Apr 13, 2023
Africa
The new article addresses the aspects related to specific rules for medical devices with a measuring function or the ones intended to be sterile. The document also describes the general approach to be followed when applying classification rules. Table of Contents The...
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Apr 6, 2023
Africa
The document highlights the key points related to the current classification rules for different types of medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a...
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Aug 23, 2022
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...
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Aug 21, 2022
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...
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Aug 16, 2022
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...
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