register

News & Trends - MedTech & Diagnostics

TGA on shortages of surgical masks and gowns

Health Industry Hub | March 25, 2020 |

The demand for surgical masks, surgical and isolation gowns, and surgical suits may overtake the supply available to healthcare organisations during the COVID-19 pandemic.

Masks had already been in short supply after months of Australian bushfires. The COVID-19 crisis and shortage of masks has led some pharmacies and online businesses charging exorbitant prices for these.

In response to this increased demand, the Department of Health, Office of Health Protection (OHP) and the Therapeutic Goods Administration (TGA) has prepared the following information to assist healthcare organisations as they update their operating procedures during the outbreak.

The presentation and claims made regarding face masks and gowns will determine how these products are regulated by the TGA.

Register FREE and join 20,000+ industry professionals who receive the latest industry news, innovations and insights from Health Industry Hub; the ONLY one-stop-hub connecting Australia’s Pharma, MedTech and Biotech industry professionals.

Face masks or gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.

If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.

The TGA and Office of Health Protection (OHP) are collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid longer term shortages of these products.

Customer engagement during COVID-19. Health Industry Hub combines expertise in delivering digital health content and measuring engagement with 20+ years industry experience. Created by industry for industry. Contact us.


News & Trends - Pharmaceuticals

Is the government is gearing up to release the long-awaited response to The New Frontier report?

Government’s long-awaited response to The New Frontier report unveiled after two-year wait

Health Industry Hub | December 1, 2023 |

Pharma News: The Albanese Government has tabled its response to the House of Reps inquiry and The New Frontier report […]

More


News & Trends - Pharmaceuticals

Gilead welcomes HIV Taskforce report and celebrates the 'unsung heroes'

Gilead welcomes HIV Taskforce report and celebrates the ‘unsung heroes’

Health Industry Hub | December 1, 2023 |

Pharma News: On World AIDS Day, the National Association of People with HIV Australia (NAPWHA) and Gilead Sciences Australia have […]

More


News & Trends - Pharmaceuticals

AbbVie secures PBS listing of first therapy for Crohn's disease in seven years

AbbVie secures PBS listing of first therapy for Crohn’s disease in seven years

Health Industry Hub | December 1, 2023 |

Pharma News: AbbVie’s Rinvoq (upadacitinib), a once-daily tablet, has been officially listed on the Pharmaceutical Benefits Scheme (PBS) for adult […]

More


ESG

New report calls on policy integration of sustainability in medical device and pharmaceutical registrations and funding

New report calls on policy integration of sustainability in medical device and pharmaceutical registrations and funding

Health Industry Hub | November 30, 2023 |

ESG: Increasing pressures from diverse stakeholder groups, spanning policymakers, investors, customers, and employees, have elevated Environmental, Social, and Governance (ESG) […]

More


This content is copyright protected. Please subscribe to gain access.