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 European Union (EU) during 2015/2016. These requirements echo changes made to the Therapeutic Goods (Medical Device) Regulations 2002 as amended which are specific to IVDs....
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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......
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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....
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The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The document is aimed at ensuring the legal framework is adhered to and that the message received by consumers from therapeutic goods manufacturers is factual and evidence based....
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Brazil’s regulatory agency, Anvisa, has introduced reforms to simplify classification processes for IVD products. From the 18th of May 2012 IVD manufacturers will be subject to new regulations which are aligned with the Global Harmonisation Task Force (GHTF) principles and therefore similar to the world’s major IVD markets. The new system is characterised by 9 classification rules which are based on the following 5 criteria:...
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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....
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The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and resolving product recall situations. Despite its importance, the term recall is currently not harmonised. The term has different meanings depending on region which can result in confusion for regulatory authorities and users worldwide. The Global Harmonisation Task Force (GHTF) has released a draft guidance document which may just pave the way for harmonised terminology, clarifying things for all medical device manufacturers....
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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......
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The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers. The regulatory bodies ANMAT (Argentina), ANVISA (Brazil), INVIMA (Colombia) and CECMED (Cuba) have recently signed an agreement as a result of an initiative which was passed during the Pan-American Health Organisation (PAHO/OPS) September/October 2010 summit. The details of the mutual agreement are to be defined during 2012 and it is hoped that the agreement will be operative from 2013. The four regulatory bodies will work independently to......
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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......
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