The TGA are working towards the deadline of 30 July 2014 to finalise the reclassification of total or partial hip, knee and should joints. In another step towards this deadline,...
As part of medical device framework reforms, the TGA seem to be dramatically increasing the number audits completed on medical device applications for inclusion on the Australian Register for Therapeutic...
The TGA have implemented two new website functions to provide better access to device information. Details are below. Adverse Event Database (DAEN) In a response to the need for more...
To manufacture and sell a medical device in Australia, you must hold certification from the Therapeutic Goods Administration (TGA). Depending on the risk level of the device you manufacture, requirements...
REALISE. COMMERCIALISE. OPTIMISE. PATHWAYS TO ACHIEVING MEDICAL DEVICE COMMERCIAL SUCCESS. COMMERCIALISE “By failing to prepare, you are preparing to fail” Benjamin Franklin This workshop will help you: Avoid commercial failure...
REALISE. COMMERCIALISE. OPTIMISE. PATHWAYS TO ACHIEVING MEDICAL DEVICE COMMERCIAL SUCCESS This workshop will benefit those involved in medical devices & IVDs in Australia across the full lifecycle – from concept...
Medical devices and IVDs are almost always supplied with labelling, instructions for use and packaging – which often includes a web address and other marketing materials. The Therapeutic Goods Administration...
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) when it...
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 Medicines and...
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 (IVF)/Assistive Reproductive Therapies (ART)...