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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In preparation for the merge of the Australian Therapeutic Goods Administration (TGA) and New Zealand (NZ) Medsafe, Medsafe have published a change the existing process for defining medical devices and pharmaceuticals in NZ. Medsafe has released the Medicines Amendment Act of 2013 which alters the existing Medsafe system to align more closely with Australia’s framework for determination and classification from 1 July 2014. As part of this change, Medsafe have developed product categorisation guidelines to reflect the updated definitions and guidance manufacturers. Medsafe now distinguishes devices from drugs based on mode of......
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The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US with the aim of developing a consistent approach for a regulatory framework for medical software to be shared among the AHWP. Singapore has been a primary contributor to the paper which provides an overview of requirements in place for medical device software in larger jurisdictions such as Australia, the US, EU, Japan, and Canada. In a story published by Clinica, Peter Linders,......
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Malaysia has a well established regulatory system for medical devices governed by the Health Sciences Authority (HSA). The market has a reputation for being difficult to enter from a regulatory perspective – often deemed time consuming and complicated. Clinica recently published a story on ‘cracking the market’ in Malaysia, using the words of experience from Dr Henningsen, who has first-hand experience of accessing the market in Singapore. Dr Henningsen described the regulations as: complex – but well documented; meticulous – but not unreasonable; and offering a slow e-system – but it works.......
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The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012. The Pilot Program is now due to begin in 2014 and will bring a new era for medical device manufacturers. The global approach to consistent audit requirements is hoped to facilitate improved monitoring of devices and reduce burden for manufacturers. The MDSAP is designed to ensure a single audit of a medical device manufacturer will provide efficient and thorough coverage of the diverse international regulatory requirements of......
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Formal decisions which will shape the future regulatory landscape of the EU are yet to be made by officials. Significant change is on the horizon however it is difficult to say when and how this will play out. Information being released shows the EU remains indecisive however the concepts of a centralised regulatory body and two regulations to replace the Medical Device Directive, IVD Directive and Active Implantable Device Directive are well and truly looking likely. Stay tuned for further updates as the EU grind slowly towards to a safe and efficient......
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New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should an adverse event occur with a supplied device. Medsafe advise, recall actions are serious matters. They are also not isolated matters. Between 1-Jul-2012 and 30-Jun-2013 Medsafe was advised of 705 medical device market actions, resulting in 101 recalls, 173 corrective actions, and 25 alerts. The balance of actions related to devices where the affected lots/batches/versions were not supplied in New Zealand, or where the device......
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The TGA have announced that a component of the medical device reforms outlined in the TGA blueprint will not go ahead. The initiative to record all devices included under a device kind/type Australian Register for Therapeutic Goods (ARTG) inclusion was designed to improve medical device traceability and identification. The proposal required Sponsors to nominate the names of all individual devices included under one ARTG. Feedback received by the TGA showed strong support from consumers however industry were less positive about the change. In an update published in early August, the TGA indicate......
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REALISE. COMMERCIALISE. OPTIMISE. PATHWAYS TO ACHIEVING MEDICAL DEVICE COMMERCIAL SUCCESS. COMMERCIALISE “By failing to prepare, you are preparing to fail” Benjamin Franklin This workshop will help you: Avoid commercial failure by understanding critical drivers for success Plan an effective pre and post commercialisation strategy Plan and prioritise your regulatory submission Hit the ground running to commercialise your device. Full day workshop, catering provided. Cost: $395 (GST inclusive). Dates and locations are listed below. BRISBANE: Thursday 1st August 2013, Ashurst, Level 38, Riverside Centre, 123 Eagle Street MELBOURNE: Tuesday 6th August 2013, Ashurst,......
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