As Health Canada presses on with adopting the Medical Device Single Audit Program, concern is growing that companies will struggle to get certified in time.
Medical device manufacturers operating in Canada are starting to worry that they will not have enough time to meet the country’s deadline for them to become certified under the Medical Device Single Audit Program (MDSAP).
MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program as of Jan. 1, 2019, but there...
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.
