www.fdanews.com/articles/124022-tga-devicemakers-should-prepare-for-adoption-of-new-standards
TGA: Devicemakers Should Prepare for Adoption of New Standards
January 27, 2010
Devicemakers manufacturing therapeutic products in Australia should implement a quality risk management system that is fully documented
and monitored for effectiveness by July, the Therapeutic Goods Administration (TGA) says. The recommendation is one of several included in a TGA presentation posted
on the agency website to prepare for new guidelines for good manufacturing practices.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor