New Australian law on IVD framework to apply from 1 July
This article was originally published in RAJ Devices
The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements1-3.
You may also be interested in...
Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.
Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.
The UK’s Health Research Authority has agreed in principle to implement a new policy that aims to drive a lasting change in clinical trial transparency. Not everyone is convinced.