So you’ve found a new medical device that is just what Australia needs? Follow these steps to better understand the regulatory requirements for selling medical devices in Australia. Before we...
The TGA have released a proposal paper introducing changes which could shake things up for Australian and overseas medical and IVD device manufacturers. The paper explores changes which could affect...
The Mutual Recognition Agreement between Australia and the European Union (EU), the EC MRA, facilitates medical device sponsors (entities or individuals who place medical devices on the market in Australia)...
The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing an early warning system for...
In light of the recent PIP breast implant adverse events and other significant device recalls, the GHTF has finalised a new standard called N87 (based on a previous guidance document...
From July 1 2012, hip, knee and shoulder joint implants will be classified as Class III medical devices according to the Therapeutic Goods (Medical Device) Regulations 2002. The change comes...
The Mexican healthcare product regulatory body, Cofepris, has been working to development and release new requirements and agreement for therapeutic goods in Mexico. The changes are described below:
Three new MEDDEV documents have been released. The documents are a fantastic resource for medical device manufacturers placing product on the market or carrying out other related activities in the...
It has been reported by law firm Sidley Austin that a new rule has been issued by the Chinese State Food and Drug Administration (SFDA) which is designed to simplify...
The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be potentially implemented in the...