Australia Emergency Use Pathways for Medical Devices

Medical devices and IVDs are regulated by the Therapeutic Goods Administration (TGA) in Australia. The standard process includes providing evidence of conformity assessment from the TGA, or acceptable overseas regulator, to obtain an Australian Register of Therapeutic Goods (ARTG) listing number (TGA approval). The approval process timeframes vary based on device classification and generally range from a few weeks to several months.

In response to the COVID-19 outbreak, the TGA has emergency exemptions that allow for the importation and sale of some devices, including COVID-19 IVD test kits, and products without the normal registration requirements, or expedited registrations, where applicable.

Regulations, guidance, and resources

The exemption routes are based on and described further in the following legislation and guidance:

Device types and eligibility criteria

Emergency Exemptions for COVID-19 Test Kits

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2020 enables accredited pathology laboratories to continue using their own tests, or tests already approved for diagnostic use, in screening donors of blood, tissues, organs, etc. for COVID-19. Notably, these tests are Class 4 in-house IVDs and normally must be included in the ARTG.

The TGA believes that while enough COVID-19 IVDs have been included on the ARTG there is still a lack of commercially-available tests for screening donors for COVID-19, and accredited pathology laboratories may use their own tests for this purpose.​

The emergency exemption will be in effect until 30 June 2021.

"Accredited pathology laboratories" are "those accredited as medical testing laboratories eligible for claiming to Medicare for approved pathology services."​​​


Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

The TGA has provided information on the expedited assessment for inclusion of COVID-19 tests as Class 3 IVDs in the ARTG. In addition to the ARTG application and review process/requirements, the special conditions for the ARTG inclusion imposed for these tests are discussed, including some conditions specific to serology-based point-of-care tests and rapid antigen tests.

This information should be reviewed together with the TGA's Legal Supply of COVID-19 Test Kits page.

All COVID-19-related applications are expedited as a matter of priority. 

Emergency Exemptions for Face Masks and Other Protective Articles

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 are now exempt from certain provisions of the Therapeutic Goods Act 1989, including the Essential Principles, conformity assessment procedures, and inclusion in the ARTG. These devices can now be supplied directly to the Department of Health (DoH), 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​ will remain in effect until 31 January 2021.

NOTE: The exemption does not permit the general supply of these items by sponsors to healthcare facilities or consumers. Further, the exemption only applies to devices that are not already included in the ARTG in the name of the supplier.

Additionally, the TGA is currently supporting the inclusion of products that may be used in the COVID-19 response (including those that are not included in the exemption) in the ARTG ​as a priority. 


Guidance on Personal Protective Equipment (PPE)

PPE with claims for therapeutic use (e.g., surgical and examination masks intended to ​reduce or prevent the transmission of disease or micro-organisms), or intended for use in a clinical​ setting, are regulated as medical devices and must be included in the ARTG. However, non-sterile protective or safety apparel/equipment for use at home, or for occupational use, are declared to not be therapeutic goods under the Therapeutic Goods (Declared Goods) Order 2019.​


Guidance on Registration of Thermometers

The guidance for thermometers and other temperature measuring medical devices includes advice on classification, conformity assessment, and the ARTG application process, and re-emphasizes that the TGA is currently prioritizing all COVID-19-related reviews. The TGA will process these applications as an urgent priority.​


Regulation of Hand Sanitisers

The TGA has excluded specified hand sanitizer formulations from TGA regulation where they meet the particular ingredients and exact formulations, and comply with specified manufacturing practices, advertisement and labeling conditions. In addition, manufacturers are required to test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping. These requirements are outlined in the Therapeutic Goods (Excluded Goods – Hand Sanitisers) Determination 2020.

This exclusion will facilitate the urgent and continued supply of hand sanitisers for healthcare facilities and consumer use. The products will continue to be regulated as consumer goods under Australian Consumer Law.

The TGA also published an Advertising Claims and Hand Sanitizers page, which reminds advertisers that therapeutic use claims that directly or indirectly refer to COVID-19 are​ prohibited, regardless of this exclusion.​

 

Get free AU regulatory updates on COVID-19

 

Regulation of Cleaners and Disinfectants

Currently, applications for pre-market approval of disinfectants with claims related to COVID-19 are being expedited as an urgent priority.

Products intended to clean or disinfect medical devices are regulated as medical devices in Australia and require ARTG listing. Liquids, sprays, wipes, and aerosols intended to disinfect/sterilize medical devices are Class IIb, while cleaners that do not claim to be a disinfectant or sterilant are Class I.

Hard-surface disinfectants with specific claims (e.g., kills, or is active against, viruses) are also regulated and must be included in the ARTG. Others are exempt from ARTG listing but must still comply with relevant requirements for exempt disinfectants.

General cleaners and sanitizers that do not have disinfectant claims are not regulated by TGA, unless they are used on medical devices.

The TGA also reminds disinfectant manufacturers making claims against COVID-19 to comply with the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, as well as the TGA's instructions for disinfectant testing​ and the use of surrogate viruses for ​efficacy testing.


Surrogate Viruses for Use in Disinfectant Efficacy Tests

The TGA has specified​ that manufacturers who wish to claim ​efficacy against COVID-19 for a hard-surface disinfectant or a disinfectant that is a medical device can use the following surrogate viruses: Human Coronavirus 229E and Murine Hepatitis Virus. However, if these viruses cannot be used, companies are instructed to contact the TGA (contact information linked above) for consideration of other surrogate human or animal coronaviruses​.


Expedited Review for Ventilators

The TGA released information for clinicians regarding ventilators, which indicates that the TGA is currently expediting the pre-market approval of new ventilator devices. Further, the TGA may accept devices that comply with the recently published guidance from the UK Competent Authority (MHRA), Rapidly Manufactured Ventilator System Specification, with adaptations for certain equivalent Australian standards.


Guidance on Ventilators and Other Respiratory Support Devices

The TGA released guidance for healthcare facilities who wish to source additional equipment for treatment of COVID-19 in the event ventilators become insufficient. The guidance provides additional information regarding alternatives to purpose-made ICU ventilators, in addition to the guidance page titled "Information for Clinicians on Ventilators and Alternative Strategies When in Short Supply."


COVID-19-related Specimen Collection Swabs

The TGA released guidance for specimen collection swabs, which are medical devices and must be included in the ARTG. The TGA is prioritizing applications of collection swabs related to COVID-19. Collections swabs may be Class I, Class I sterile, Class IIa, or Class 1 (IVD) devices, depending on their sterility, intended purpose, etc. Guidance specific to 3D-printed collection swabs is included, as well.


Clinical Trial Processes

The TGA has announced the prioritization of clinical trials related to COVID-19, along with relevant advice/instructions for Sponsors.

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 an online CTN form has been submitted and the relevant fee has been paid for priority processing​.

The TGA also specifies that certain deviations/variations to a CTN caused by COVID-19 conditions (e.g., change to the trial start/finish date) do not need to be notified. ​

For the Clinical Trial Exemption (CTX) scheme, Sponsors are also encouraged to contact the TGA as soon as possible in order to prioritize the ​evaluation.​


Pathway Overview

ARTG applications for COVID-19 IVD tests are being expedited. The standard registration pathway applies; however, the sponsor is encouraged to inform TGA of the lodged ARTG application so that it may be prioritized.

Face masks and other protective articles can now be supplied without an ARTG listing directly to the Department of Health (DoH), or another agency of the Commonwealth acting on behalf of the DoH, if under contract with said agencies.

Updated on 11 September 2020.

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