Medical Device Regulation Resources
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is...
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.
HSA
The article provides a general overview of the approach to be followed when preparing a submission associated with a medical device intended to be placed on the market in Singapore.
HSA
The new article clarifies the scope of information to be included in the submission to ensure all the essential matters are adequately addressed, the submission is complete, and the authority has all the necessary information to make the regulatory decision.
