Australia
The article provides a comprehensive overview of the requirements to be followed by a party responsible for a recall when preparing and issuing a sponsor’s customer letter to ensure all the critical safety-related information is appropriately communicated to the addresses.
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 describes the approach to be applied with respect to mandatory recalls initiated in order to avoid the customers’ exposure to healthcare products that could potentially be harmful when used for the intended purpose.
Australia
The new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from a regulatory standpoint.
Australia
The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
