![TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Roles](https://www.regdesk.co/wp-content/uploads/2024/04/TGA-on-recalls-roles.jpg)
May 20, 2024
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.
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![TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Mandatory Recalls](https://www.regdesk.co/wp-content/uploads/2024/04/TGA-on-recalls-mandatory-recalls.jpg)
May 20, 2024
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.
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![TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 8-10](https://www.regdesk.co/wp-content/uploads/2024/04/TGA-on-recalls-step-8-10.jpg)
Apr 26, 2024
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
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![TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Types and Classes](https://www.regdesk.co/wp-content/uploads/2024/04/TGA-on-recalls-types-and-classes.jpg)
Apr 26, 2024
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.
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![TGA Guidance on Conformity Assessment Certification Applications](https://www.regdesk.co/wp-content/uploads/2024/03/TGA-on-conformity-assessment-applications.jpg)
Apr 12, 2024
Australia
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
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![TGA Consultation on CDSS Software Regulation: Overview](https://www.regdesk.co/wp-content/uploads/2024/04/TGA-on-CDSS-software-overview.jpg)
Apr 8, 2024
Australia
The article highlights the critical points related to the regulatory status of certain software products.
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