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
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) to use CE Marking certificates as evidence of conformity to Australian regulatory requirements for some medical devices. Since being signed in 1998, the Agreement has provided a much shorter path to market in Australia for most CE Marked medical devices. However, the EC MRA has recently undergone changes which restrict previously covered devices. Changes came into affect on January 1 2013 and......
Continue Reading
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
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
At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force (GHTF)) a number of progressions were made. The Forum includes international medical device regulators from Australia, Brazil, Canada, Europe, Japan and the USA and has an aim to strategically accelerate international medical device regulatory convergence. It is hoped that this will provide medical device manufacturers with a more efficient path to certification worldwide. As indicated above, the Forum has fundamentally similar objectives to the......
Continue Reading
An online system for the reporting of problems associated medical devices (adverse event reports) is now available to industry and consumers. The Therapeutic Goods Administration’s (TGA) new reporting system consists of online forms which can be accessed from the links below....
Continue Reading
The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, released on 1 July 2010. The guidance is easy to understand and is a must read for Australian in-house IVD manufacturers....
Continue Reading
On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a number of products that were not on the Australian Register for Therapeutic Goods (ARTG). This comes as stern reminder for all therapeutic goods manufacturers and suppliers that regulatory requirements should be a key component of business practice in Australia. The decision shows that the Federal Court can and will impose significant penalties on therapeutic goods manufacturers and suppliers who import or supply......
Continue Reading
The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. The reforms are designed to improve the transparency and efficiency of therapeutic goods regulation and will affect almost all manufacturers and sponsors of therapeutic goods in Australia. The government’s blueprint includes the following: Plans to focus on improving communication and engagement with the community with the intention of becoming a well known and understood regulatory agency. Plans to establish an Australian Therapeutic Goods Advisory Council......
Continue Reading
The ACMD stands for the Advisory Committee on Medical Devices, a committee which provides independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on safety, quality and performance of medical devices supplied in Australia including issues relating to premarket conformity assessment and post market monitoring. The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990 and the members are appointed by the Minister for Health and Ageing. ACMD review applies to most Class III medical device conformity assessment applications and their advice can have......
Continue Reading