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KD&A in Sydney

KD&A have established an office in Sydney to better assist in the development and support of clients in Eastern Australia. KD&A is an Australian company specialising in medical device regulatory affairs with offices in both Adelaide and Sydney. KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets, both Australian and international. KD&A have significant experience with a vast range of medical devices and regulatory processes. We pride ourselves on providing high success rates and quality customer service. Our ability to understand what practical regulatory......

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TGA Extend Reclassification Transition Deadline

The TGA have announced an extension to the deadline for the reclassification of hip, knee and shoulder joints. The due date for final transition has been extended by one year to 30 June 2015. There will be no annual charges applied for transitioned Class III joint implants until after 30 June 2015, and reclassification applications submitted by 30 June 2015 are not subject to mandatory audit requirements or related audit fees (reclassification applications may be selected for discretionary audit, for which no fees apply). Why the extension? The TGA indicate that the......

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Risk Assessment - ISO 14971

Risk assessment is a key component of Technical Documentation for medical devices. The risk assessment process ensures that medical device manufacturers suitably consider and mitigate the potential risks associated with the use of their device as part of the product development and eventual certification process. KD&A recommend that the internationally recognised standard ISO 14971 be used to assist manufacturers in the process risk assessment and mitigation. Risk mitigation can come in many forms – however there is a general hierarchy of mitigation activities:   Design Device design should consider the intended purpose......

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TGA Time Frames - How Long Should You Wait?

Are you waiting to hear from the TGA about your new medical device or IVD application? Maybe it’s an application audit response…. read on for more information about TGA time frames… There are two categories of time frames used within the Australian medical devices regulatory framework. These are as follows: 1.        Legislated time frames: these are times that are specified within the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002. 2.        Target time frames: these are anticipated time frames that......

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TGA Reclassification Deadline Drawing Closer

The TGA announced the reclassification of hip, knee and shoulder joint implants (total and partial) in 2012. The announcement required medical device manufacturers and sponsors to update their product certification and Australian Register for Therapeutic Goods (ARTG) inclusion – transitioning from a Class IIa/IIb to a Class III.  A transition period was granted however this is due to conclude on the 30th June 2014. As described in our news story dated September 2012, reclassification applies to a number of products. The GMDN codes associated with affected devices on the Australian Register for Therapeutic......

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Building Technical Documentation Effectively

Product development is an all consuming process, taking considerable time and effort. An important activity associated with product development is the building of Technical Documentation to support your medical device for regulatory submissions. Technical Documentation is used describe a medical device and specify how a manufacturer has demonstrated that the product is safe and performs as they intend it to (in normal conditions). Building Technical Documentation is a complex and detailed task. Some key factors, which feed into Technical Documentation, to consider in the early stages as part of product development are......

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Planning is Key for Regulatory Success

Planning is a recognised and vital step in the development of any medical device…. planning of design, manufacture, customer requirements … the list goes on. However regulatory requirements are often disregarded until submissions for certification is required. The regulatory framework surrounding medical and IVD devices is complex – insufficient planning from the beginning can result in significant delay and cost for manufacturers and distributors who haven’t factored regulatory requirements into their overall plan.  Whether we like it or not, regulatory compliance is a vital piece of the pie when it comes to......

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KD&A - How Can We Help you in 2014?

KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance. Regulatory Strategy Development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market. Quality Management......

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