FDA
The document highlights the key points related to the requests for information to be submitted under the existing legal framework.
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.
EU
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
HSA
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.
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