The Canadian government wants to strengthen its oversight of medical devices, both on the pre-market and post-market sides, partially in response to recent Canadian news reports on safety issues with implantable devices, the country's health minister says.
Health Canada plans to issue an action plan for strengthening its medical device approval in the "coming weeks," the country's health minister announced in a statement responding to a recent string of media reports spotlighting device risks and perceived gaps in government oversight.
The agency is reviewing options for enhancing its pre-market oversight, post-market surveillance and transparency of its regulatory processes, Minister of...
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.
