FDA
The new article provides additional recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
FDA
The article provides an overview of the existing legal framework and also describes the key concepts related to the matter.
HSA
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.
HSA
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.
HSA
The new article describes the regulatory requirements concerning high-risk products – Class C and D medical devices.
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