New medical devices system on track for implementation in 2002

Australia is to adopt a world-leading system of medical device regulation under legislation currently before the Federal Parliament. The Therapeutic Goods Amendment (Medical Devices) Bill 2001 improves medical device safety and brings Australia into line with international best practice by putting into place the principles of the Global Harmonization Task Force.

These principles aim to harmonise international regulatory requirements to ensure consistency between nations, allowing faster consumer access to new medical technologies, better protection of public health through easier resolution of device problems, and the reduction of costs for both consumers and industry through the removal of regulatory duplication.

Under the new system, Australia will move away from a prescriptive regulatory system that recognises unique standards in the form of Therapeutic Goods Orders, with the British Pharmacopoeia as the default standard.

Instead, manufacturers will be able to use TGA 'gazetted' standards, based on international standards, to demonstrate that technical requirements have been met. Industry will benefit from increased flexibility in the way they demonstrate that their devices meet the substantive requirements of safety, performance and quality. However, manufacturers of all medical devices will still be required to meet manufacturing standards and all except those manufacturing the lowest risk devices will be audited and have their systems certified.

The level of regulatory control will be proportional to the degree of risk associated with a medical device, taking into account the benefits offered by use of the device. The calculated level of risk depends on its intended purpose and the effectiveness of the risk management techniques applied during design, manufacture and use. This approach will ensure appropriate management of any risks associated with new and emerging technologies.

Applications for entry onto the Australian Register of Therapeutic Goods (ARTG) will be streamlined using a new electronic lodgement process called the Device Electronic Application Lodgement system, or DEAL. The TGA will be notified of low risk devices through DEAL, enabling sponsors to market these products without undue delay.

An increased emphasis on post-market vigilance, with mandatory reporting requirements for adverse incidents and provisions for tracking of high risk implantable devices, will also improve medical device safety. In a world first, Australia will introduce a mandatory reporting timeframe of 48 hours for adverse events that represent a serious public health threat or concern.

The global model for the regulation of in-vitro diagnostic products (IVDs) is still under development, so IVDs will continue to be regulated under the current system. However, it is expected that these products will be brought into the new regulatory framework within two years.

Products currently on the ARTG will have five years to meet the new requirements. There is also provision for a two-year transition period for specified new products not previously manufactured to a certified quality system.

Extensive consultation with consumers, the medical devices industry and professional groups, employed during the development of the amendment Bill, will continue with the finalisation of detailed requirements to be included in the Medical Device Regulations.