Regulatory

Regulatory update

31 March 2020

  • TGA COVID-19 information for clinicians on ventilators and alternative strategies when in short supply. Read more.
  • TGA issues warning about illegal advertising relating to COVID-19. Read more.
  • MedTech Europe Statement on EU Commission intention to postpone MDR deadline. Read here.

25 March 2020

Industry has been working closely with the TGA to enable faster access to life-saving medical equipment. A number of exemptions and fast-tracking processes have now been put in place:

  • On 22 March 2020, an exemption was enacted to enable faster access to PPE. This will facilitate necessary access to certain kinds of medical devices that are used for the prevention, monitoring, treatment or alleviation of COVID-19. (In practice, disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors, which are designed to be worn by individuals to prevent the transmission of organisms.)
  • A new emergency exemption, Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories. In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these devices.
  • The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG. All COVID-19 tests that are included on the ARTG based on this expedited assessment process are subject to additional non-standard conditions, which makes it easier for the TGA to perform additional post market assessments as experience and knowledge around COVID-19 diagnostic testing grows. The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval.

TGA issues warning about illegal advertising relating to COVID-19

The TGA Regulatory Compliance Branch is increasing its monitoring of non-compliance in relation to products that claim to prevent, treat or cure COVID-19. A media release regarding the illegal advertising of therapeutic goods relating to COVID-19 has been published on the TGA website: https://www.tga.gov.au/media-release/tga-issues-warning-about-illegal-advertising-relating-covid-19.