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Some IVDs and Radiology devices to be exempt from FDA 510(k)

The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devices with well established safety and effectiveness profiles. In a draft guidance document, the agency has listed 30 different device types that it intends to exempt from 510(k) notification requirements through the appropriate regulatory processes. Stakeholders had until October 2011 to submit feedback on the guidance, which includes devices for which FDA believes that a less stringent oversight would not compromise public health and safety. These include......

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EU publish much awaited draft regulation for e-labelling of medical devices

The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into force during 2012. The proposed regulation sets out conditions under which instructions for use in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professionals users and for which use by other persons is not reasonably foreseen. While acknowledging the benefits of e-labelling, the commission states that the possibility of providing instructions......

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TGA Release Update Regarding Proposed Regulatory Framework Reforms

The TGA proposed regulatory reforms during October 2010 in response to the Australian Government Health Technology Assessment Review (HTA) and after considerable consultation further information has been released. The announced reforms will have an effect on almost all medical device manufacturers and sponsors placing medical devices on the market in Australia. Read on to see how the reforms affect you....

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US Food and Drug Administration (FDA) Issue New Regulatory Guidance

The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical device. This guidance replaces the 1997 guidance document and is important to those considering making changes to a previously approved device....

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Health Canada Makes Changes to Medical Device Establishment Licensing Framework

Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medical devices into Canada. Specifically, it serves as the method by which medical device companies selling on the Canadian market demonstrate to Health Canada that their product meets all of the applicable regulatory requirements. This includes procedural documentation, handling of complaints, storage and delivery of devices, and installation and servicing of devices (if applicable). KD&A can develop documentation in conjunction with your organisation to ensure the Health Canada regulatory......

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Six Essential Web Resources, Australian Medical Device & IVDs

The internet is a vast resource and hunting through available information can be time consuming  – making it difficult for you to find what you need, when you need it. As an Australian medical device or IVD manufacturer or sponsor there are some key websites which allow you to have valuable and reliable information at your fingertips.  The sites below are worth adding to your favourites list.   The Therapeutic Goods Administration website acts as an excellent resource, providing information such as the Australian Regulatory Guidelines for Medical Devices and IVD guidance......

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TGA Launches NEW Improved WEBSITE  - Find documents and guidance more easily

On 4 May 2011 the TGA is going to launch its new website.  A site map and navigation guide have been released by the TGA to assist users, these documents can be found at http://www.tga.gov.au/newsroom/media-2011-website-110406.htm. The  TGA information email service is also undergoing change, including more frequent emails and a new format....

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