The government has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 to amend the current regulations on post-market surveillance of medical devices placed on the market in Great Britain (“PMS Regulations“). The draft statutory instrument was notified to the World Trade Organization and made available on their website …
The Therapeutic Goods Act 1989 sets out the criteria for the inclusion of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG), the process for securing authorisation from the Therapeutic Goods Administration (TGA), and requirements for advertising, labelling and product appearance. Medical devices that incorporate or are comprised of …
Datascope/Maquet/Getinge is recalling the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may shutdown unexpectedly due to electrical failures in the Power Management Board or Solenoid Board (Power Source Path). Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate …