HSA Revised Guidance on Medical Device Product Registration: Overview
The article outlines the key points associated with registering healthcare products under the existing legal framework.
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.
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
The new article highlights the aspects related to the general principles of clinical evaluation.
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.