Australia – New guidance published on manufacturer evidence for IVD medical devices
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a...
UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during...
USA – FDA revamps device software premarket submissions guidance
The US Food and Drug Administration (FDA) this week finalized guidance on the content of premarket submission for software functions in medical devices. The...
USA – Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed...
The US Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have formed a partnership aimed at curbing medical device shortages. A 22...
USA – FDA updates Q-Sub guidance ahead of new Pre-Sub draft guidance
The US Food and Drug Administration has updated its final guidance on its Q-Submission program in line with changes negotiated in the recent medical...
Canada – Proposed changes to the Medical Devices Regulations to address future public health...
Health Canada is proposing regulatory amendments to the Medical Devices Regulations (MDR). We're proposing to expand the current provisions under Part 1.1 of the MDR, currently...
USA – AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance
The medtech lobby group AdvaMed has asked the US Food and Drug Administration (FDA) to make changes to its recent guidance on orthopedic non-spinal...
USA – FDA finalizes guidance for containment system used with power morcellators
The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
Australia – Phase out of ISO 13485 certificates for IVD medical devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26...
