The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical...

The article provides an overview of the regulatory framework for additional notifications related to medical devices. Table of content The Food...

The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and...

The article addresses the aspects related to the authority’s expectations associated with the respective program. Table of content The Food and...

The article highlights the key points related to the regulatory status of boundary products in Australia. Table of content The Therapeutic...

The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant...

The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting. Table...

This article highlights the aspects related to the approach to be applied when determining whether a notification is required. Table of...

The article addresses the aspects related to the fees payable by the interested parties and also provides definitions of the most important terms and...

The article highlights the key points associated with the regulatory framework for specific categories of medicinal products. Table of content ...

The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the...

The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for...