TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Overview
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
The new article describes in detail the first three steps of a recall process, which include obtaining information and distribution status, conducting a risk analysis, and deciding on the type, class, and level of recall.
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
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
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
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