Canada
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
HSA
Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue opportunities. However, expanding operations and reaching new countries can be highly challenging for these...
HSA
The article provides a general overview of the existing legal framework for advertising healthcare products allowed for marketing and use in Singapore.
HSA
The new article describes in detail the key aspects related to the advertising activities in the context of medical devices intended to be marketed in Singapore.
FDA
The new article provides additional clarifications regarding various testing methodologies to be used when assessing the thermal effect caused by medical devices when used for the intended purpose, as well as the risks associated with it.
FDA
The new article outlines specific aspects associated with the evaluation of medical devices impacting the tissue temperature including, inter alia, the ones related to computational modeling as one of the assessment methods to be used.
