HSA Revised Guidance on Medical Device Product Registration: Specific Aspects
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
The article outlines the key points associated with registering healthcare products under the existing legal framework.
The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.