IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 60601 group of medical electrical equipment safety standards. A commonly used standard, 60601-1 is an important tool for manufacturers when demonstrating compliance with the Essential Principles and Essential Requirements. Standards selection and compliance is an important component of device development, manufacture and testing. Some changes debated and included in the third edition of 60601-1 are as follows: The scope of 60601-1 has been expanded......
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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......
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Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medical devices. Medtech experts from around Europe have collaborated to produce a report in which they argue that it is time to introduce randomised clinical trials (RCTs) in the EU for high risk medical devices (these are defined as innovative Class III medical devices and innovative implantable medical devices).The authors also propose centralising the evaluation process of these products....
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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 In a draft guidance document, the agency has listed 30 different device types that it intends to exempt from 510(k) notification requirements through the appropriate regulatory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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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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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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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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Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The joint scheme will reduce regulatory burden for industry in both Australia and New Zealand....
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The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&A can provide an effective and reliable solution....
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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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