Software as a Medical Device – Upcoming Changes to the Australian Regulations
With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...
Keeping it Clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods
The COVID-19 pandemic has seen a marked increase in the production of hand sanitisers. Depending on the composition, intended use and any claims made in relation to their use, hand...
China restricts export of COVID-19 supplies to approved products only
In response to alarming reports of defective COVID-19 test kits, face masks and other emergency supplies, China has taken swift action to restrict the export of medical products which are...
TGA expedites COVID-19 approvals, while keeping up business as usual for other devices
The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
Expedite! Emergency device regulatory approvals in a pandemic
These are difficult times – and we need fast, really fast, regulatory reviews. So how does this work – how have regulators adapted to the COVID-19 pandemic? What new and...
Six uncomfortable regulatory truths in a pandemic
These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia
Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers...