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TGA reforms: A blueprint for TGA's future

25 September 2014

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Medical devices

Current regulatory arrangements of medical devices

The TGA regulates the quality, safety and performance of medical devices supplied in Australia, using a regulatory framework which allows inclusion of medical devices in the ARTG. The fundamental components of the framework set out requirements for safety and performance of a medical device and a classification system based on the risk the device presents to the patient, the user and the environment.

Medical devices are classified according to the intended purpose of the medical device and the degree of risk involved for the patient and user. The device classifications are determined through the Therapeutic Goods (Medical Devices) Regulations 2002, and take into account factors such as the degree of invasiveness in the human body, the duration and location of use and whether the device relies on a source of energy. The level of pre-market assessment of medical devices is commensurate with the risk classification. The lowest risk devices (Class I) including things like tongue depressors and bandages can be automatically included in the ARTG based on declarations given by the sponsor. The level of evidence required for higher risk devices increases with increasing risk classification.

The regulatory framework for medical devices includes provision for post-market monitoring by the TGA including checking evidence, conducting periodic inspections of a manufacturer's quality management systems and technical documentation (including documentation held by a sponsor), and imposing specific requirements for manufacturers and sponsors to report, within specified timeframes, adverse incidents involving their medical devices.

In addition to this, the TGA receives expert orthopaedic input on hip, knee and shoulder arthroplasty devices through the independent expert advisory committee, the Orthopaedic Expert Working Group (OEWG).

The National Joint Replacement Registry (NJRR), created through an arrangement with the Commonwealth Department of Health, also provides post-market surveillance on joint replacement procedures carried out across Australia to ensure ongoing safety and efficacy of the medical devices implanted.

The Registry contains the most complete set of data relating to hip and knee replacement in Australia. The data is used to inform surgeons, other health care professionals, government bodies, including the TGA, orthopaedic device companies and the community.

Issues

The current entry of products onto the ARTG allows for several devices from one sponsor to be included under a single device description. These individual devices may not appear distinctly on the ARTG. This makes it difficult to identify if a particular device is in fact listed on the ARTG or not, and makes it difficult to identify the products in the event of a recall of the device.

There have also been community concerns that have arisen with some joint replacement implants. This has led to calls to increase the pre-market scrutiny of these and other high risk prostheses.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Medical devices.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

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