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Tips for transitioning to ISO 13485:2016

Transition planning is critical As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important to consider the resources and time required to update your Quality Management System (QMS) as well as regulator assessment times. In addition, companies must also define the project so that there is clear understanding of the specific processes that need the most work and the impact that this work has on any other requirements. Planning considerations We recommend......

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The CE Mark matters in medical markets

Selling any product into the European market can be simplified if a manufacturer can show that it complies with appropriate regulations. For medical device manufacturers, this compliance is vital.  Regulatory strategy planning is a critical step in the development and marketing of any medical device so it is important to understand the regulatory requirements of target markets, which can be quite different from country to country. It is equally important to have a clear understanding of the intended use, indications and claims for a device as these influence how to classify or......

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Meeting Medical Software Regulatory Requirements

The development of a sound regulatory strategy is an essential starting point for medical device and in-vitro diagnostics (IVD) manufacturers. Regulatory strategy planning is critical to ensure compliance with all legislation and standards, particularly because the regulatory environment can vary from country to country. When developing a strategy, there are several factors that must be considered including customer needs and the nature of a particular target market. What changes software into a medical device? The definition of a medical ‘device’ also tends to vary by country so a good starting point is......

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The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?

In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News these regulations are likely to be adopted by late 2016 or early 2017. Will these regulation changes impact the Australian Manufacturer? It depends. The Australian Department of Health, Therapeutic Goods Administration (TGA) announced in 2014, “Commencing on 5 November 2014, Australian medical device manufacturers are able to use conformity assessment certification from European notified bodies when making applications to the TGA.” This was good news for......

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One submission for multiple markets a future reality?

The International Medical Device Regulators Forum (IMDRF) was created in February 2011 as a forum of medical device regulators from different regions around the world with the aim to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization. The IMDRF members are Australia, Brazil, Canada, China, Europe, Japan, Russia, and USA.The latest development of the IMDRF is the creation of a Table of Contents (ToC) intended to provide a harmonised international electronic submission structure for the evaluation......

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EU New Medical Device Regulation 2016

The EU new Medical Device Regulation (MDR) could be ready for adoption as early as by the end of 2015. Although it is more realistic to think the new regulations will be ready to be implemented in early 2016, it is important that all Australian manufacturers and exporters to the EU are aware of the changes currently taking place with the medical device regulations in the EU. The new MDR proposes to replace the current Medical Device and IVD Directives. The main points that are currently being evaluated by the European Commission......

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TGA Annual Invoicing Time – Avoid ARTG Cancellations

If you are a medical device sponsor, you would have received or you are about to receive the TGA annual charge invoice. It is important to ensure all your details are up to date with the TGA and that the payment of the invoice is done no later than September 15th to avoid cancellations of your ARTG Certificate. If you qualified in the past for the Low Value Turnover (LVT) scheme, from July 1st 2015 the scheme was replaced by the Annual Charge Exemption (ACE) scheme. The TGA pre-qualified certain entries that......

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TGA Joint Replacements Refunds on Related Ancillary Devices

After the reclassification of hip, knee and shoulder joint replacement from Class IIb to Class III medical devices on 1 July 2012, there was a 3 year transition to complete the reclassification process. The reclassification in Australia was modelled on the reclassification of these implants in the EU as Class III implants. During the Australian transition, it became apparent that there were differences in interpretation of the classification rules within the EU itself. And since many manufacturers rely on European certification to support market entry in Australia, it was agreed that clarification......

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New TGA Business Site

In an effort to improve the current customer experience with the TGA ebs site, the TGA has developed a new customer friendly portal that promises to improve the on-line experience for manufacturers, sponsors and TGA agents. The new site is being launched on Tuesday 28 April 2015 and will be called TGA Business Services. There will be a series of upgrades that will be slowly implemented. The first upgrade will allow eBS clients to access a user-friendly site that will allow them to: Access and manage their contact details and other information,......

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