DRAP
The new article describes in detail the relevant inspection process, highlighting the key points to be considered by the parties involved.
HSA
The new article provides an overview of the activity controls introduced to ensure operations conducted by medical device manufacturers (software developers) align with the relevant regulatory requirements.
HSA
The new article provides recommendations and clarifications on a broad range of matters with a primary focus on the ones related to cybersecurity considerations for software medical devices intended to be marketed and used 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.
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.
