Australia Considers Role of Third-Party CABs

Australian officials are considering whether the country’s devicemakers that market products domestically should be able to use third-party conformity assessment bodies (CABs) to show adherence to product and quality standards. Currently, the Therapeutic Goods Administration must assess applications for domestic products and certain high-risk devices, such as drug-eluting coronary stents and tissue-based devices. Australian industry says that requirement gives foreign companies an unfair advantage.
International Medical Device Regulatory Monitor