Asia
The present article provides an overview of the regulatory requirements to be applied for the premises used for the distribution of medical devices. In particular, the article addresses the aspects related to the storage conditions required to ensure medical devices...
FDA
The article provides an overview of the applicable regulatory requirements in the sphere of labeling for medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article describes in detail one of the regulatory pathways to be used in case of changes to an already marketed medical device – a 30-day supplement. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The new article provides additional details regarding the submission process itself. In particular, it covers the aspects related to the content of the submission and also outlines the scope of changes for which the submissions are required. ...
FDA
The article provides an overview of the applicable regulatory requirements concerning the manufacturing facilities. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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...
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