FDA
The new article describes in detail the matters related to the evaluation of substantial equivalence under the 510(k) premarket notification framework. In particular, the article describes the aspects related to predicate devices – similar medical devices...
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
Asia
The second article provides additional details regarding the responsibilities of the parties involved in clinical trials and the most important aspects associated thereto. Table of Contents Turkey has published a new regulation on clinical trials...
Asia
The first article provides an overview of the general provisions of a new draft regulation on clinical trials for medical devices. Table of Contents The Turkish regulating authority has published a draft regulation on clinical trials for medical devices....
Ethiopia
The new article provides additional details regarding the documents required when importing medical devices in Ethiopia, as well as the information these documents should contain. Additionally, the article describes the procedures to be followed when importing medical...
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