When countries with well-developed health systems scrambled to purchase life-saving ventilators at the start of the COVID-19 crisis, it illustrated just how serious the pandemic would be. Working on a war footing, governments from Australia to China, Europe and the US asked the industry to produce ventilators and personal protective equipment at speed. Companies from gin distilleries to car manufacturers valiantly answered the call to make medical devices to meet global demands. Behind the scenes, however, managing the risks created by this unprecedented situation has been challenging.
Emergency Use Authorisations (EUAs) in the Asia Pacific region, such as Australia, China, Japan and South Korea have allowed anyone wanting to manufacture or market devices such as ventilators, personal protective equipment and COVID-19 tests to apply for temporary approval, bypassing the standard authorisation process, which can take up to a year depending on the product class. However, it can be more commitment and product liability than consumer manufacturers bargained for in an area they are unfamiliar with. As the legal manufacturers of the medical devices, the onus is on them to stay on top of all the associated regulatory burdens, such as conducting market surveillance on the product for its entire lifespan and maintaining it regularly.
For established medical device manufacturers, the desire to answer calls for help may not have created new risks, but it has raised the stakes, with the global supply chain under strain as production ramps up and fresh regulatory complexities become apparent. Even when COVID-19 eventually goes into retreat, the industry will still have its work cut out ensuring the equipment built during an emergency is not used when healthcare systems resume normal service.
Read the “Making Medical Devices During a Pandemic” report to find out more about the liabilities faced by consumer manufacturers pivoting to help in the fight against COVID-19, and the challenges - some of which will linger even after the pandemic is over - that confront specialist manufacturers.
Read more reports in the ‘Life Science in the era of pandemics’ series:
This content is brought to you by Chubb Insurance Malaysia Berhad, Registration No. 197001000564 (9827-A) (“Chubb”) as a convenience to readers and is not intended to constitute advice or recommendations upon which a reader may rely. Any references to insurance cover are general in nature only and may not suit your particular circumstances. Chubb does not take into account your personal objectives, financial situation or needs and any insurance cover referred to is subject to the terms, conditions and exclusions set out in the relevant policy wording. Please obtain and read carefully the relevant insurance policy before deciding to acquire any insurance product. A policy wording can be obtained at www.chubb.com/my, through your broker or by contacting any of the Chubb offices or Chubb agents. Chubb makes no warranty or guarantee about the accuracy, completeness, or adequacy of this content. It is the responsibility of the reader to evaluate the quality and accuracy of material herein.
© 2022 Chubb. Not all coverages available in all jurisdictions. Chubb® and its respective logos, and Chubb. Insured.℠ are protected trademarks of Chubb.
We help you stay ahead and informed with these helpful tips and tricks