The new article highlights the approach to be applied concerning counterfeit medical devices, as well as the way the parties involved should handle complaints...

The present article describes in detail the way the least burdensome approach should be applied. In particular, it explains the ideas behind the concept...

The new article describes in detail the good assembly practice principles to be applied for medical devices and also provides additional clarifications regarding the...

The article provides an overview of the regulatory requirements for monkeypox tests intended to address the public health emergency. In particular, the document describes...

The new article provides additional clarifications regarding the regulatory matters related to post-market obligations, and distribution records, and also summarizes the regulatory requirements associated...

The new article describes in detail the responsibilities of the regulating authority concerning the determination of risk associated with medical device studies; and also...

The new article highlights the aspects related to the main principles on which the least burdensome approach is based, and also describes the key...

The new article highlights the main points related to the secondary assembly of medical devices intended to be marketed and used in Australia. In...

The new article describes the responsibilities of institutional review boards (IRBs) when assessing clinical studies related to medical devices, as well as the approach...

The article provides an overview of key points and principles related to the least burdensome provisions.  Table of Contents The Food...

The article provides a brief overview of the regulatory requirements related to various studies medical devices could be subject to.  Table...

The new article describes in detail the requirements associated with the special pathways to be used to make unregistered medical devices available for healthcare...