Mediqol

The Therapeutic Goods Administration (”the TGA”) has recently published an overview of its intended new regulatory requirements that will apply to in vitro diagnostics. Having read through the documentation it appears that the major points are:

• IVD’s will be regulated as a subset of medical devices and will be subject to a risk based classification system (4 classes)
• Class 1 products will be self-certified by the manufacturer. The TGA will accepted certification from a recognised regulatory body for Class II and III products. Class IV products (high public health risk) will require a TGA conformity assessment
• Once a product is approved and being sold in Australia manufacturers will have post market responsibilities
• There will be a transition period of four years