The Therapeutic Goods Administration (TGA) has implemented a number of expedited pathways and exemptions from requirement, for inclusion on the Australian Register of Therapeutic Goods (ARTG) for medical devices required for the COVID- 19 pandemic.
- Expedited COVID-19 medical device application process
- Exemption to enable the domestic manufacture and supply of ventilators
- Exemption for coronavirus (COVID-19) medical devices
The expedited pathways and exemptions allow for the supply to Australian facilities where they are required urgently and to fulfil the need for test kits, mask and ventilators.
The TGA has also established an expedited Recall pathway to ensure that products that are found to not meet the requirements of these exemptions, or are faulty to be quickly removed from the Australian market. This process will be coordinated by the TGA Recalls Section, and recalls will be initiated within 24-hours.
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