News


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) when it comes to performance and testing.  The IVD regulation is reasonably new (having come into force in 2010) and new IVD manufacturers are still in the process of better understanding requirements. The ACMD is a statutory advisory committee established by the Therapeutic Goods Regulations 1990. The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific......

Continue Reading


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 Medicines and Healthcare products Regulatory Agency (MHRA) has issued a guidance document to provide device manufacturers with an overview of requirements described in Regulation 207/2012. The Regulation defines IFU as information provided by the manufacturer to inform the user of the device of its safe and proper use, of its intended performances and of any precautions to be taken as outlined in the Directives......

Continue Reading


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 (IVF)/Assistive Reproductive Therapies (ART) devices, in addition to medical devices.  The guidance remains for the most part unchanged, however the inclusion of IVF/ART devices results in changes to the incident reporting criteria for manufacturers. The guidance also explores the difficult task of defining indirect harm and serious deterioration of patient health for IVF/ART device manufacturers. MEDDEV 2.12-1, revision 8 is applicable from July 2013. Ensure your......

Continue Reading


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 Australia. Before we start, remember KD&A can assist you with all of the actions listed below, visit our Product Registration page for more information.  FIRST THINGS FIRST Ensure the device manufacturer will work with you to obtain Therapeutic Goods Administration (TGA) Australian Register for Therapeutic Goods (ARTG) inclusions (which allows you to put the device on the market. We recommend you get this in writing.......

Continue Reading


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 which could affect all companies entering the Australian market, particularly new medical devices which are higher risk (IIb, III and AIMD). In an attempt to improve control of devices and improve transparency, the following has been proposed. Mandatory Application Audits (MAA) changes. The potential overhaul includes two key actions; Expanding the list of devices requiring MAA which falls in line with recent changes to the......

Continue Reading


Early Warning Mechanisms for Australia and New Zealand

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 adverse event and recall situations. The system is one of many projects being worked on as part of the creation of one regulatory agency, the Australian New Zealand Therapeutic Products Agency (ANZTPA)....

Continue Reading


GHTF Release New Standard

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 GHTF/SG2/N54:2006). The new standard outlines a system for medical device manufacturers and competent and regulatory authorities to exchange information regarding medical device adverse events electronically....

Continue Reading


Hip, Knee and Shoulder Joint Reclassification – TGA Announce Regulation Changes

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 after the Therapeutic Goods Administration (TGA) consultation paper, Reforms in Medical Devices Regulatory Framework, was released in late 2010. Australia is not the only country to make such changes, a number of overseas countries have reclassified these products in an aim to improve safety and quality for patients....

Continue Reading