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.
Australia
The new article describes certain specific aspects related to the regulatory framework for the designation of conformity assessment bodies in terms of regulatory requirements applicants should meet.
Great Britain
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
