FDA
The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
Czech Republic
The article describes in detail the aspects related to the responsibilities of the parties involved in the distribution process.
HSA
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
FDA
The new article highlights the key points related to the specific aspects of selecting proper predicates to demonstrate compliance with the applicable regulatory requirements for the medical device in question is subject to.
BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
