IVD Point of Care Tests Go Under the Spotlight
The Therapeutic Goods Administration (TGA) ACMD (Advisory Committee on Medical Devices) recently held a meeting to review the requirements for IVD Point of Care Tests (class 3 IVDs
European Union Commission Release New Vigilance Guidance
The EU Commission have released revision 8 of MEDDEV 2.12-1: Guidelines on a Medical Device Vigilance System. The updated version includes guidelines for In Vitro Fertilisation (IV
Electronic Age: UK MHRA Issue Guidance On eIFU Requirements
The EU regulation on electronic Instructions for Use (IFU) (Regulation 207/2012) came into force on March 1st 2013. In response to the implementation of electronic IFUs, the UK Med
TGA Release Proposal Paper: Are Tighter Controls and Alternative Options for Conformity Assessment Ahead?
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
Regulatory Requirements: A Simple Guide for Australian Medical Device Distributors
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 Austral
