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...
Ethiopia
The new article describes in detail certain specific aspects related to the labeling for medical devices intended to be marketed and used in Ethiopia, including the way the labeling should be placed and the information it should contain. ...
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
Asia
The article provides a brief overview of Pakistan’s regulatory requirements in the sphere of importation and exportation of medical devices and highlights the key points to be considered by medical device manufacturers and other parties involved in placing medical...
FDA
The new article describes in detail the aspects related to the intended use of medical devices and the ways it should be considered when evaluating substantial equivalence. Table of Contents The Food and Drug Administration (FDA or...
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