HSA
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.
HSA
The article outlines the key points associated with registering healthcare products under the existing legal framework.
HSA
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.
HSA
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
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