Medical devices Australia

The Global Harmonisation Task Force (GHTF) was conceived in 1992 to address similar issues for medical devices. It has a broader regional base than its pharmaceutical counterparts in that it includes representatives from Canada and Australia in its core group, in addition to those from the EU, US and Japan. In some ways, it also faces a stiffer challenge in that there is more divergence in the regulatory... 

A MRA on standards and conformity assessment between Australia and the EC came into effect from 1999, covering eight industry sectors including GMP inspection and batch certification of medicinal products, and conformity assessment of medical devices. 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

Current details of the regulation of medical devices and diagnostics in Australia may be obtained through the TGA website. 

Diphoterine is a product for chemical spatters on the eye and skin. Prevor Laboratory in France manufactures this odorless, colorless liquid dispensed as an eye wash or skin decontamination spray. It is composed of an aqueous solution to wash many chemical families and pull hydrophilic chemical agents away from the surface of tissues, an amphoteric solution that acts on acids and bases and restores the tissue physiological pH, and a hypertonic solution that stops penetration of corrosive chemicals into tissues. The pH is slightly alkaline (pH 1.2-1.1) and is sterile. Although not classified as such in the USA, it is classified as a medical device in Europe, Canada, Australia, and Brazil (www.prevor.com). 

Many other applications for plasma polymers in the Life Sciences have been dted, often in relation to implantable medical devices or materials, with the goal of concealing the device from the bodies defence mechanisms, or improving cell colonisation of the material, e.g. endothelial cell growth into vascular grafts. A number of excellent studies from the group of Hans Griesser (CSIRO, Australia) describe the use of plasma polymers as substrates to which biomolecules can be immobilised. These immobilisations have been demonstrated to enhance the medium-term acceptability of contact lens materials and may prove relevant to implantable devices. 

The main objective of using an internationally coordinated safety standard such as lEC 60601-1/UL2601-1 is that a medical device could be designed and evaluated for compliance with a single standard and thus can be sold in many different countries without any problem. Currently, the countries that use the lEC 60601-1 standard include Canada, European Union coimtries, Japan, Australia, and South Korea. 

The European Union (EU) attempted a more standardized and rational approach to the classification and regulation of medical devices along broad risk-based categories. Canada and Australia have used a similar approach in their regulation of medical devices. To determine how a new product is regulated in the EU system, an individual first determines classification based upon certain rules . These rules are illustrated in a flow chart which can be read to determine how a device may be regulated, more or less independently of the details of construction or materials. 

Kaolin is a low cost, naturally occurring, white or pale coloured mineral, very widely used in the paper industry but also to a lesser extent in plastics for cable insulation, wire coating, footwear, flooring, pipes, window frames, garden furniture, agricultural film, medical devices and automotive parts. It is mined in North America, Brazil, the CIS, Europe and Australia. 

Governments around the world approve the sale of medical devices in many different ways. In Australia the Therapeutic Goods Administration issues an Australian Register of Therapeutic Goods number to devices cleared for the market. In Canada a device licence is awarded by the Therapeutic Products Directorate. In the European Union, after receiving an EC certificate from a notified body, the manufacturer places the CE mark on the device. In Japan a shounin is issued by the Pharmaceutical and Medical Safety Bureau of the Ministry of Health, Labor and Welfare. In the United States the manufacturer of the device receives a marketing clearance (510(k)) or an approval letter (PM A) from the FDA. 

Vendor information facilitates governments in tracking medical device vendors. In Australia the sponsor must hold an enterprise identification number before being permitted to apply to register or list products. Similarly, in Canada any individual or company wishing to sell medical devices must apply for permission to obtain an establishment licence. The European Union requires a responsible person of the vendor establishment with a physical address in Europe be registered. In Japan, medical device... 

System in March 2007 for use in the US Army, Navy and Air Force. It is also an approved medical device for nerve agent decontamination in the European Union, Australia, and Canada. The efficacy of RSDL to remove and decontaminate CWAs was demonstrated in vivo with guinea pigs and in vitro with chick embryos. 

Two devices are commercially available. Thera-Sphere (glass microsphere MDS Nordion, Kana-ta, Canada) was approved in 1999 by the Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE) for the treatment of unresectable hepatocellular carcinoma (HCC) in patients who can have appropriately positioned hepatic arterial catheters with or without portal vein thrombosis [1]. SIR-Spheres (resin microsphere Sirtex Medical, Lane Cove, Australia) were granted full pre-marketing approval in 2002 by the FDA for the treatment of colorectal metastases in conjunction with intra-hepatic FUDR [2]. Both devices have European approval for liver neoplasia and approvals in various Asian countries. 

Fernando Martin Sanchez holds PhDs in informatics and in medicine. He is chair of Health Informatics at the University of Melbourne, Melbourne, Australia, and the director of the university s Health and Biomedical Informatics Centre. He has more than 100 peer-reviewed publications and his research has been funded by some 30 grants from the European Commission the Spanish Ministries of Health, Science, and Defense and the Australian National Health and Medical Research Coimcil, the Institute for a Broadband Enabled Society, and Department of Health and Ageing. His research interests cover a wide range of topics related to the role of informatics in precision medicine (genomics and exposomics) and participatory health (social media, quantified-self, and mobile apps and devices). 

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