HSA Guidance on Medical Device Product Registration: Overview
The article provides a general overview of the critical points associated with the registration procedures for healthcare products intended to be marketed and used in Singapore.
The article provides a general overview of the critical points associated with the registration procedures for healthcare products intended to be marketed and used in Singapore.
The new article provides an overview of the medical device registration process in general. Also, it describes in detail the approach to be followed for registration of Class A and B products.
The new article describes the regulatory requirements concerning high-risk products – Class C and D medical devices.
The new article describes the key steps and requirements associated with pre-market product registration in the context of software medical devices intended to be marketed and used in the country.
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.