The Therapeutic Goods Administration (TGA) has moved quickly to assist with the manufacture of vital equipment needed to treat COVID-19 cases.
In a statement, the TGA said it had received an increased number of enquiries from people seeking to develop medical devices, and had published new minimum technical requirements for domestically-manufactured ventilators.
“These requirements ensure the ventilators are suitable for supply and use in Australian hospitals when approved devices are not available during the COVID-19 emergency,” the TGA said.
“Businesses with the capability to manufacture ventilators must ensure they can deliver ventilators in line with these specifications.”
It said it implemented a number of expedited pathways and exemptions from requirement, for inclusion on the Australian Register of Therapeutic Goods (ARTG).
“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 said.
“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.”
It said this process would be coordinated by the TGA Recalls Section, and recalls would be initiated within 24 hours.
“If you are able to manufacture devices or device components we recommend that you register your interest and core competencies on the COVID-19 Manufacturer Response Page,” the TGA said.