The article highlights the aspects related to the regulatory status of the changes related to medical devices allowed...

The new article highlights the aspects related to the requirements for the entities involved in conformity assessment and...

The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses....

The new article highlights the aspects related to the obligations and responsibilities of medical device manufacturers and their...

The document highlights the key points associated with the licensing requirements for medical device establishments. ...

Medical Device Regulatory Professional...

Medical Device Regulatory Professional...

The new article addresses the aspects related to the quality management system in the context of medical devices...

The new article addresses the aspects related to device-specific requirements, and also describes the procedures to be followed...

The new article provides an overview of the regulatory requirements for the clinical evaluation of medical devices based...

The document provides an overview of the regulatory approach to be applied with respect to medical devices based...

Medical Device Regulatory Professional...