TGA Release Additional IVD Guidance
New IVD requirements (Regulations implemented on July 1, 2010) have brought a number of challenges for IVD manufacturers and sponsors in Australia. To assist, the TGA have released a number of guidance documents, the most recent being ‘What a sponsor needs to know about conformity assessment and manufacturer’s evidence’.
The guidance document is intended to describe the conformity assessment process in detail, along with providing specific instructions relating to manufacturer’s evidence.
Despite the release of guidance documents, IVD manufacturer and sponsors still have their work cut out to ramp up regulatory actions and comply with the new TGA requirements. If your organisation could do with some assistance to complete activities, or require guidance on the Regulations, contact KD&A for a quote.
All IVD specific TGA guidance documents can be found on the TGA website.