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.
HSA
The article provides a general overview of the regulatory framework for product registration submissions, including the relevant procedures for applying for marketing approval in Singapore.
TMMDA
The article highlights the critical points related to the legal framework for medical device testing, control, and calibration.
Australia
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
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