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Understanding MDSAP

MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration (TGA) – Australia • Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil • Health Canada (HC) – Canada • Food and Drug Administration (FDA) – US • Ministry of Health and Labour and Welfare (MHLW) – Japan The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit......

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The Importance of Risk Management

Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA......

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Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

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Why is regulatory strategy so important?

The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a......

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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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