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News Bulletin : ADA News Bulletin October 2011
11 OCTOBER 2011 Importing dental products INTO AUSTRALIA committee report OvERvIEW Of THE REGULATORY EnvIROnMEnT An open market which supplies dentists and oral healthcare professionals with a range of products at a competitive price is encouraged in Australia. Underpinning this is the need for confidence that the products supplied by the dental industry are safe and comply with the standards and regulations designed to achieve this outcome. The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries. The objective of the Therapeutic Goods Act (Cth) 1989 is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and of medical devices. For the purposes of the legislation most types of dental equipment and many of the materials used in dental practices are deemed to be medical devices. IMPORTInG PROdUCTS – KEY REGULATORY REQUIREMEnTS Under Australian law most therapeutic goods need to be supplied in accordance with the framework established by the Therapeutic Goods Act (Cth) 1989. This legislation is administered by the Therapeutic Goods Administration (TGA) which regulates the quality, safety and performance of medical devices, e.g., dental equipment that is manufactured, imported and/or supplied in Australia. The TGA has established a classification system for medical devices based upon the risk to the patient, user and environment. The classification allows the TGA to set more complex standards and monitoring regimens for higher-risk medical devices. All types of medical devices (including dental equipment) must appear on the Australian Register of Therapeutic Goods (ARTG). It is the responsibility of each Australian manufacturer or importer to organise the ARTG entry, even if an identical product, i.e., the same product is being imported by another party and already on the ARTG. Some types of equipment, such as X-ray imaging devices, may also need to be installed and operated in accordance with state legislation. IMPORTInG PROdUCTS – KEY STAndARdS REQUIREMEnTS Most types of equipment need to be manufactured in accordance with the relevant product technical standard which may include an International Standard (ISO), Australian Standard (AS), joint Australian/New Zealand Standard (AS/NZS), European Standard (CEN) or an American Standard (ANSI). Manufacturers of medical devices must ensure that their devices comply with all applicable rules and regulations that relate to the operation or supply of their device in Australia, regardless of whether the requirements directly relate to medical regulatory aspects or not. For example, a manufacturer of an electrically powered medical device that uses water must comply with each of the appropriate electrical and water regulatory requirements that apply nationally and in each of the states and territories. Depending on the piece of equipment these technical standards may govern the design, manufacture, installation, calibration and maintenance of equipment. In many cases these standards will be referenced in regulations thus compliance with the standards is mandated by law. There are more than 500 standards relevant to dental equipment and consumables in Australia and it is therefore not practical for ADIA to provide advice as to which standards are relevant to each type of product. Importers should also familiarise themselves with quality system standards. It is necessary for an importer to have on record, or access to, documentation providing an independent assessment that a product meets the required standard(s). THE AUSTRALIAn REGISTER Of THERAPEUTIC GOOdS (ARTG) The ARTG is a computer database of therapeutic goods and in all but a very few cases medical devices must be included before they may be supplied in or exported from Australia. There are around 60,000 products listed on the ARTG. The Therapeutic Goods Act (Cth) 1989 and subordinate legislation sets out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods are covered by the relevant state or territory legislation. For a medical device to be included in the ARTG, the TGA must be satisfied that evidence exists appropriate to the perceived risks of the device to support its safe and effective use, and that an appropriate system is in place for monitoring the ongoing performance and safety of the device. If an importer wants to supply a device that is identical to a device that is already on the ARTG, even if both devices are made by the same manufacturer, an application to include the device on the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia, but also a record of all the sponsors who are legally responsible for the medical devices on the market.
ADA News Bulletin September 2011
ADA News Bulletin November 2011