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
