The Therapeutic Goods Administration (TGA) is working to keep industry informed with the latest information on medicines and medical devices in light of COVID-19 and information is being updated rapidly.
To stay up to date with the TGA’s regular updates, the regulator has provided a new dedicated Coronavirus (COVID-19): Information on medicines and medical devices webpage, or you can subscribe to a weekly compilation email of new and changed items on the TGA Internet site, as well as same-day notification for media releases.
New web pages from the TGA this week include:
- Manufacturing medical devices for COVID-19 including 3-D printing: Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
- COVID-19 test kits included on the ARTG for legal supply in Australia: A list of tests approved (with conditions) for inclusion on the Australian Register of Therapeutic Goods (ARTG).
- Exemption to enable the domestic manufacture and supply of ventilators: An exemption from some pre-market regulatory requirements is now in place for domestically manufactured invasive ventilators that meet certain specifications and testing requirements published in Ventilator for COVID-19 use in Australia.
- Ventilator for COVID-19 use in Australia: This new specification details the minimum technical requirements for manufactured invasive ventilators when approved devices are not available during the COVID-19 emergency.
- COVID-19 point-of-care tests: Important information about the use of COVID-19 point-of-care tests.
If you do not find what you are looking for on the TGA website, you can contact the Medical Devices Information Unit by emailing: email@example.com or calling 1800 141 144, for further information.