Following a prolonged and very public debate about the price of implantable devices in private hospitals in Australia, an agreement has been reached between the Australian Federal Government and the medical device industry that will give certainty to manufacturers selling devices in the Australian market. The agreement has a downside in that $300 million of […]
There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
As Indian Central Drugs Standard Control Organization counts the days to the January 2018 start date for the new Indian Medical Device regulations, the Asian Harmonisation Working Party meet in New Delhi from 4-8 December. We will be there.
US FDA releases draft guidance on expedited review for breakthrough devices – and they want access to your wordprocessor and to chat a lot by phone! We take a look at how FDA wants to roll up its sleeves and work with device developers.
On 25 October, the US FDA released final guidances on when a changes to hardware or software require a new 510(k). The new guidances provide a wealth of detail and lots of flow charts. Underneath it all there’s strong reliance on formal ISO 14971 risk assessment – which should mean much greater consistency in need to file new 510(k) and need for Conformity Assessment review in Europe and other GHTF model markets.
CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?