Brazil IVD Requirements – Aligned with GHTF Principles
Brazil’s regulatory agency, Anvisa, has introduced reforms to simplify classification processes for IVD products. From the 18th of May 2012 IVD manufacturers will be subject to
In-house IVDs – TGA Release New Guidance
The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, relea
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
EU publish much awaited draft regulation for e-labelling of medical devices
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into fo
