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.
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.
The new article describes in detail special regulatory requirements concerning software medical devices utilising Artificial Intelligence technology to ensure the specific risks associated with it are duly addressed.
The article provides a general overview of the existing legal framework for advertising healthcare products allowed for marketing and use in Singapore.
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.
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.
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