FDA
The article describes in detail the aspects related to the way in which comparison to a similar medical device already placed on the market is to be provided, and also on the labeling requirements to be fulfilled to ensure all the important information related to the...
Africa
The new article addresses the aspects related to specific rules for medical devices with a measuring function or the ones intended to be sterile. The document also describes the general approach to be followed when applying classification rules. Table of Contents The...
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
FDA
The new article describes in detail the aspects related to the applicability of recommendations provided in the guidance in terms of medical devices and regulatory pathways. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Saudi Arabia
The new article highlights the aspects related to the requirements applicable to the entities providing medical maintenance services, and also the services in the sphere of technical consultation. Table of Contents The Saudi Food and Drug Administration (SFDA), a...
