The medical device industry is eager to explore regulatory proposals to introduce Unique Device Identification (UDI) in Australia. However, when it comes to implementation of a system, medtech firms claim they should be given enough time to clear non-UDI-compliant products from their inventory in distribution channels.
Industry has welcomed regulatory proposals to introduce a Unique Device Identification (UDI) system for medical devices in Australia, but says that when it comes to implementation companies should be given enough time to deplete their inventory of non-UDI-compliant products in distribution channels.
The Therapeutic Goods Administration in January launched a public consultation seeking comments on its plans to
US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
