On October 3, the TGA announced a revision to the URPTG, which is accompanied by a 3 month “familiarisation period” before taking effect on 15th January 2018. We take a look at the new expectations TGA has of manufacturers and sponsors. What would you do – are you prepared for a recall?
Archives for November 2017
China’s CFDA released draft regulation changes in October with far reaching proposals including faster Clinical trial approvals and abolition of Type Testing. At the same time CFDA is getting tougher in postmarket supervision. This could all be law by Chinese new Year.
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US FDA releases draft guidance on expedited review for breakthrough devices – and they want access to your wordprocessor and to chat a lot by phone!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.