Australia’s Therapeutics Goods Administration (TGA) has taken numerous actions in recent months to respond to the global outbreak of COVID-19, announcing new exemptions and expedited pathways to ensure rapid registration and supply of medical devices and IVDs needed to combat the pandemic. The regulatory body has also published guidance documents and made important announcements pertaining to device manufacturers and importers.
Expanded exemption from ARTG listing for COVID-19 test kits and other devices
As noted in an earlier blog post, on January 31 the TGA published the Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020, applying to COVID-19 test kits and other devices used to diagnose, prevent, or treat the disease. This exempted such devices from some provisions of the Therapeutic Goods Act 1989, including being listed on the Australian Register of Therapeutic Goods (ARTG), for facilities that were members of the Australian Public Health Laboratory Network (PHLN).
On March 22 the TGA published the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, which repealed the earlier regulation and expanded the scope of the exemption contained therein. Rather than only PHLN members, the exemption now applies to all “accredited pathology laboratories,” which are defined on a TGA information page as “those accredited as medical testing laboratories eligible for claiming to Medicare for approved pathology services.” The exemption will remain in effect until January 31, 2021. A summary of regulatory pathways for COVID-19 test kits can be found here.
New exemptions for face masks and ventilators
Also issued on March 22 was the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020. Effective immediately, this exempts 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, from requirements such as conformity assessment procedures and inclusion in the ARTG. These devices can now be supplied directly to the Department of Health, or another agency of the Commonwealth acting on behalf of the DoH (e.g., state and territory health departments), provided that the person supplying these are under a contract with said agencies. This exemption also remains in effect until January 31, 2021.
The TGA offered further clarification on the scope of this exemption with a statement on March 24. It specified that the exemption does not allow for the general supply of unapproved protective articles. It also explained that the exemption only applies to device that are not already included in the ARTG under the name of the supplier.
Finally, the Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020 was published on April 8. This new emergency exemption applies only to local manufacture of ventilators for use in hospitals or healthcare facilities to treat COVID-19. These devices must meet the requirements and specifications set out in the TGA’s guidance titled “Ventilator for COVID-19 Use in Australia,” and manufacturers must supply required evidence and obtain written permission from the TGA to supply their unapproved ventilators.
Expedited processes in place for approval of needed devices
The TGA announced that it is currently expediting the pre-market approval of new ventilator devices. It also may accept devices that comply with the recently published guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), “Rapidly Manufactured Ventilator System (RMVS) Specification,” with adaptations for certain equivalent Australian standards.
Applications for pre-market approval of disinfectants with claims related to COVID-19 are being expedited as an urgent priority. The TGA also reminded disinfectant manufacturers making claims about effectiveness against COVID-19 to comply with the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019. For testing purposes, manufacturers are to use human coronavirus 229E or murine hepatitis virus as surrogates or consult with the TGA if this is not possible.
A broad initiative was subsequently announced to expedite reviews for all medical devices associated with the detection, prevention, and treatment of COVID-19. Notably, this is separate from the TGA’s established Priority Review Pathway. The TGA encourages Sponsors to immediately contact them after submission of their ARTG application to submit the supporting Technical Files and data for rapid assessment.
Clinical trials and recalls also to be expedited for devices related to COVID-19
The TGA also released a statement that clinical trials related to COVID-19 will be prioritized. Although the Clinical Trial Notification (CTN) scheme does not require evaluation/approval from the TGA before the trial can begin, some Ethics Committees may still require the TGA’s acknowledgement as evidence of submission. Sponsors are therefore advised to contact the TGA’s Clinical Trials team once a CTN form has been submitted for priority processing. For the Clinical Trial Exemption (CTX) scheme, Sponsors are also encouraged to contact the TGA as soon as possible.
The prioritization approach will also be applied to swiftly removing products from the market when necessary, as the TGA announced an expedited recall process for faulty or unauthorized COVID-19 devices. Recalls will be coordinated by the TGA Recalls Section and must be initiated within 24 hours.