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Australia’s Therapeutic Good Administration has begun a postmarket review of all continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators including positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices on the Australian Register of Therapeutic Goods (ARTG).
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021.
Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey.