The Mexican healthcare product regulatory body, Cofepris, has been working to development and release new requirements and agreement for therapeutic goods in Mexico. The changes are described below:...
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Three new MEDDEV documents have been released. The documents are a fantastic resource for medical device manufacturers placing product on the market or carrying out other related activities in the European Union. The documents are as follows:...
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It has been reported by law firm Sidley Austin that a new rule has been issued by the Chinese State Food and Drug Administration (SFDA) which is designed to simplify clinical trial requirements for manufacturers of Class II medical devices. The rule is hoped to streamline regulatory review processes and timelines for eligible Class II medical devices....
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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The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices.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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