IP SPOTLIGHT MAY 18

AUSTRALIA’S EMERGENCY USE PATHWAYS FOR MEDICAL DEVICES

Medical devices and in vitro diagnostic medical devices (IVDs) are regulated by the Therapeutic Goods Administration (TGA) in Australia. The standard process for approval includes providing evidence of conformity assessment from the TGA, or acceptable overseas regulator, to obtain an Australian Register of Therapeutic Goods (ARTG) listing number (which is TGA approval). In response to the COVID-19 outbreak, the TGA has implemented emergency exemptions that allow for the importation and sale of some devices intended to assist in reducing the transmission of infection between individuals (particularly patients and health care professionals) and COVID-19 IVD test kits without the normal registration requirements, or with expedited registrations. The exemptions only apply in relation to goods that are not already included in the ARTG.

EMERGENCY EXEMPT IONS FOR VENT I LATORS The new emergency exemption is also applicable to ventilators that are not already included on the ARTG and can demonstrate compliance with minimum technical requirements. The exemption does not permit the general supply of these ventilators to healthcare facilities or consumers outside the context of the COVID-19 emergency. CL I N I CAL TR I AL PROCESSES The TGA has announced the prioritisation of clinical trials related to COVID-19, along with relevant advice/ instructions for Sponsors. The TGA also specified that certain variations to a Clinical Trial Notifications (CTN) caused by COVID-19 conditions (e.g., change to the trial start/finish date) do not need to be notified.

These exemptions will remain in effect until 31 January 2021.

EMERGENCY EXEMPT IONS FOR COV I D-19 TEST K I TS IVDs for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19 can now be supplied more broadly to “accredited pathology laboratories” under the exemption conditions. However, this does not permit the general supply of unapproved IVDs, including serological rapid tests intended for use at the point-of-care, to any other laboratories/clinics. EMERGENCY EXEMPT IONS FOR FACE MASKS AND OTHER PROTECT I VE ART I CLES Disposable face masks, gloves, and gowns, as well as protective eyewear (goggles, glasses, or visors), that are designed to be worn by individuals to prevent the transmission of organisms for use in a clinical setting are now exempt from certain provisions of the Therapeutic Goods Act 1989. However, non-sterile protective or safety apparel/ equipment for use at home, or for occupational use do not fall within these exemptions.

PENELOPE FARBEY Senior Associate

Australia has a rich history of innovation when it comes to medical technologies. And now, in this time of greatest need, that culture of innovation is empowering manufacturers to move rapidly to meet the challenges before them. An innovation journey, culminates in the creation of IP rights. A vital asset that needs to be protected and managed throughout commercialisation. Wrays has a dedicated team of medical technology experts guiding manufacturers and innovators.

Click here to discover more about how they can assist.

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