What is this role? This is a new regulatory compliance role introduced by the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. This is the first time a role of this type is officially recognised and must be appointed by the manufacturer. This is a separate role to that of the Authorised Representative. How to comply? Article 15 in the MDR and IVDR is entirely dedicated to the definition of the requirements, tasks and duties of the Person Responsible for Regulatory Compliance. It requires that manufacturers have at......
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Understanding MDSAP
Posted by:admin
November 13, 2018
in:EU, FDA, Medical Technology Regulation, News, TGA, Uncategorized
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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Time is up for the manufacturers and sponsors of IVD devices in Australia. July 1st 2015 is the deadline for the transitional period to ensure compliance with the new regulatory framework which was introduced in 2010....
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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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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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The establishment a joint therapeutic products regulator between Australia and New Zealand will no longer continue. Recently the Australian and New Zealand governments announced their agreement to cease the Australia New Zealand Therapeutic Products Agency (ANZTPA). After conducting a comprehensive review of progress and assessment of the costs, it was determined that the mutual Agency was not going to benefit either country....
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The following announcement was made in October by the Therapeutic Goods Administration: ‘New regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies.’ Fiona Nash, The Assistant Minister for Health, announced that, under the Government’s Industry Innovation and Competitiveness Agenda, new regulations will be introduced to allow Australian manufacturers to obtain market approval for most medical devices using conformity assessment certification from European notified bodies. This change will benefit Australian manufacturers by providing them with process flexibility and......
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Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical device also includes in vitro diagnostic (IVD) devices. If you are lost in the regulatory maze, don’t panic, KD&A can help you out. The Medical device regulatory framework is complex and varies significantly from device to device and region to region. KD&A has more than 21 years of experience working hand in hand with manufacturers, sponsors and distributors through the......
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The world of medical device regulation is a complicated one. There is a lot of guidance documents available, but it’s very difficult to tell which will be useful and practical in the early stages of understanding the Australian regulatory framework. KD&A have put together a list of what we consider to be our vital five Therapeutic Goods Administration (TGA) guidance documents. Here they are: The Australian Regulatory Guidelines for Medical Devices (ARGMD). This is the go to document for all TGA medical device related information. Broken up into 3 sections, this......
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This year will see the introduction of many new or revised harmonised standards relating to medical devices. Harmonised standards are used by medical device and IVD manufacturers to demonstrate compliance with Regulations and Directives. They provide a guide for manufacturers to demonstrate compliance and take the guess work out of the selecting suitable testing, materials, design features, etc....
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