Australia is proposing to introduce new medical device software rules that would result in a number of changes for industry. Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.
Australia and Canada have each launched public consultations on the regulation of software in the medtech space.
Australia’s Therapeutic Goods Administration is seeking comments on a document detailing planned regulatory reforms for medical device software –...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
The Food and Drug Administration’s final guidance outlines the agency’s thinking for sponsors submitting de novo requests electronically, which they must starting in October 2025.
