Apr 22, 2020

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the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, which repealed the earlier regulation and expanded the scope of the exemption contained therein.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.

 

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Guidance documents available for various device manufacturing concerns

The TGA published guidance documents on the following subjects:

  • Manufacturers' obligations for manufacturing medical devices and their component parts, including by 3D printing, in response to the COVID-19 emergency: Notably, the TGA advises companies interested in manufacturing devices or parts to register their interest and core competencies on the Advanced Manufacturing Growth Centre (AMGC)'s COVID-19 response page. Custom Made devices (such as those that are 3D printed for a specific patient based on a diagnostic image) do not need to be included in the ARTG.
  • Personal protective equipment (PPE) (e.g., face masks, gowns, and gloves): 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 in Australia 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.​ Several examples of masks and other PPE products are provided, with commentary on the applicable regulatory categorization in Australia.
  • Re-processing single-use products: The TGA notes that many single-use products are not appropriate for re-use, and there are risks associated with re-processing that should be considered. Also, companies that re-process single-use medical devices will be considered manufacturers and must therefore apply appropriate conformity assessment procedures and inclusion in the ARTG. Additionally, the TGA, together with the Office of Health Protection (OHP), released a page titled "Advice on surgical masks and gowns during COVID-19," with additional details on these products​.​
  • Additional equipment for treatment of COVID-19 in the event ventilators become insufficient: The guidance provides 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," which has also been updated to include all recent developments and additional advice on ventilators and their alternatives.
  • Thermometers: The guidance 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. Sponsors do not need to contact the TGA to request an expedited review; the TGA will automatically process these applications as an urgent priority.​
  • Labeling obligations: The legal manufacturer's name and address must appear on the device's label, Instructions for Use (IFU), and other information provided with the device. The Sponsor's name and address must also be provided on the device itself, or if not practicable, then on the packaging label or IFU, so that the user can readily identify the Sponsor. The guidance further outlines the required information in the label as per Essential Principle 13.3. All information​ must be provided in English.

Other TGA announcements relating to COVID-19

In addition to the numerous documents and information pages alluded to above, the TGA released other announcements regarding its operations and the regulation of medical devices intended to combat the COVID-19 pandemic:

  • Overseas inspections and audits suspended: Due to the travel restrictions put in place in response to the ongoing COVID-19 pandemic, the TGA has announced the suspension of all overseas GMP inspections and QMS audits until further notice. The TGA stated that there is no impact to domestic QMS audits, at present, but they will provide further updates if the status changes​.
  • Warning regarding advertising: In February, the TGA issued a warning to industry reminding companies that "claims such as preventing the spread of coronavirus (for example, through the use of face masks or disinfectants)... are considered to be therapeutic​ use claims." Furthermore, “promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation,” and "advertising must not be inconsistent with any current public health campaigns.” COVID-19 IVDs are not exempt from the Australian advertising framework, and advertisements cannot be directed to consumers.
  • COVID-19 testing in Australia: The TGA published information related to IVD testing for COVID-19 in the country. Notably, the TGA has decided to impose additional conditions on the supply of approved serology tests intended for use at the point-of-care. These tests may only be supplied to certain customers specified by the TGA (including accredited pathology laboratories and legally ​registered medical practitioners, among others). The TGA has also published a list of COVID-19 test kits currently included on the ARTG, with details such as the location of use and type of test.​
  • Additional information on point-of-care serology tests: The TGA subsequently published further information on point-of-care serology IVD testing for COVID-19, noting that there is significant variation in how these tests are being used across Australia. While Western Australia and South Australia have introduced certain prohibitions on the supply of point-of-care tests, other areas are permitting their use under certain conditions. Because the currently available point-of-care serology tests only detect IgM and/or IgG antibodies, they can neither determine if a person is infectious, nor detect if a person has been infected recently (within the last week or so). The TGA advises that there is significant risk relating to misinterpretation of results, for instance due to the possibility of false positives and false negatives. The TGA provides a number of recommendations for offering point-of-care testing for COVID-19​.

Related resources on Australian medical device regulation:

 

Author

  • Timothy Herr

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