GHTF Release New Standard
In light of the recent PIP breast implant adverse events and other significant device recalls, the GHTF has finalised a new standard called N87 (based on a previous guidance docum
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
What Does Recall Really Mean? The GHTF Aim to Provide Clarity
The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and resolv
