RegDesk News/Info
The article outlines the key points associated with the classification rules for medical devices.
AI
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
HPRA
The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
Bahrain
The article provides an overview of the approach to be followed in the context of the transition to the new EU-wide regulatory framework for medical devices.
Australia
The new article provides additional details on the application process to be followed by the entities interested in designation as conformity assessment bodies, as well as the assessment process associated thereto.
