HSA
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...
Asia
The article addresses the aspects related to elements of the submission template associated with the device description and information about the product to be provided by the applicant for the authority to be able to conduct a review. Table of Contents The...
Asia
The new article addresses aspects related to the way conformity to the applicable Essential Principles should be demonstrated and also outlines the key points to be considered when providing a general device description. Table of Contents The Health Sciences Authority...
Asia
The present article provides an overview of the most important aspects related to submissions for in vitro diagnostic medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
Asia
The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to...
