Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
Australia
The article outlines the roles and responsibilities of the parties involved in recalls and related activities to be taken to ensure the safety and proper performance of medical devices and other healthcare products allowed for marketing and use in the country.
Australia
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
Australia
The article provides an overview of the legal framework for labeling requirements applicable to medical devices intended to be marketed and used in Australia.
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
