
HSA Revised Guidance on Medical Device Product Registration: Class A and B
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 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 new article provides additional details regarding specific aspects associated with remote regulatory assessments.
The article outlines the key points associated with registering healthcare products under the existing legal framework.
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.