The Therapeutic Goods Administration (TGA) – the national regulator for medical devices in...
Medical Device Regulations Blog
The FDA has issued its long awaited final guidance outlining how it intends to interpret the...
The European Commission has published an initiative to ensure that active products without a...
The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed the appointment...
The Medical Device Coordination Group (MDCG) - a working group of the European Commission, recently...
One of the fundamental questions in medical device regulations (MDR) is whether a product is...
Software as a medical device (SaMD) manufacturers operating in the UK should note the new...
The Medical Device Single Audit Program (MDSAP) was created in 2012 by the International Medical...
The European Commission has published a second series of amendments to the original lists of...