Product Liability - Australia

Regulatory Framework
Regulatory Guidelines for Medical Devices
Essential Principles of Safety and Performance
Effect on Manufacturers

On March 26 2008 the federal government, through the Therapeutic Goods Administration, announced plans to develop a consolidated reference document detailing the Australian regulatory guidelines for medical devices. It is intended that the regulatory guidelines will replace the existing guidance documents and information sheets for medical devices. The Therapeutic Goods Administration anticipates that the consolidation project will be completed by the end of 2008. Further information on the consolidation process can be found on the Therapeutic Goods Administration website.(1)

Regulatory Framework

The objective of the Therapeutic Goods Act 1989, which came into effect on February 15 1991, is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and medical devices available to the Australian community.

The regulatory framework for therapeutic goods is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from unnecessary regulatory burden and ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

Essentially, therapeutic goods must be entered in the Register of Therapeutic Goods before they can be supplied in, or exported from, Australia.

The Therapeutic Goods Act (and regulations and orders made under the act) sets out the requirements for inclusion of therapeutic goods in the Register of Therapeutic Goods, including the advertising, labelling, product appearance and appeal guidelines. Some provisions, such as those on the scheduling of therapeutic goods and their safe storage, are covered by relevant legislation in the Australian states and territories.

The Therapeutic Goods Administration is a unit of the Department of Health and Ageing and is responsible for administering the provisions of the act and the regulatory regime.

A new regulatory framework for medical devices was introduced in October 2002, with a five-year transition period ending on October 4 2007. An important feature of the new regulatory framework was the need for all medical devices supplied commercially in Australia prior to October 4 2007 to transfer to the new regulatory framework and meet current internationally accepted requirements for performance, quality and safety of medical devices. There were no provisions to transfer automatically registered or listed therapeutic goods in the Register of Therapeutic Goods into the new included medical devices category in the register (ie, ‘grandfathering’ provisions).

The new requirements for medical devices are set out in Chapter 4 of the act and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Regulatory Guidelines for Medical Devices

The Therapeutic Goods Administration is in the process of developing a plain English consolidated reference document detailing the regulatory requirements for medical devices, which will eventually replace the existing guidelines and information sheets for medical devices.

As each section of the consolidated document is prepared, it will be released for industry and public comment, with a four-week deadline. The consultation process for the first draft section, “Essential principles of safety and performance”, closed on April 24 2008. The existing guidance material, however, will remain current until it can be fully replaced by the regulatory guidelines.

Essential Principles of Safety and Performance

The initial draft section of the regulatory guidelines contains an overview of the relevant essential principles of safety and performance which medical devices supplied in Australia must meet, but does not prescribe the manner in which a manufacturer must prove that it has met these essential principles.

Six general essential principles apply to all medical devices:

• The use of the device must not compromise the clinical condition or safety of a patient or the safety and health of users or any other person;
• The device’s design and construction must conform with safety principles with regard to the generally acknowledged state of the art;
• The device must be suitable for its intended purpose;
• The device must be designed and produced in a way that ensures that if it is used within its expected lifetime, is regularly maintained and calibrated in accordance with the manufacturer’s instructions and is not subjected to stresses outside those experienced by the device during normal use, the characteristics and performances outlined in the first three essential principles are not adversely affected;
• The characteristics and performance of the device (if used for its intended purpose) must not be adversely affected by transport or storage carried out in accordance with the manufacturer’s instructions; and
• The benefits to be gained from the use of the device for its intended purpose must outweigh any undesirable side effects arising from its use.

There are a further eight essential principles regarding design and construction to apply to medical devices on a case-by-case basis:

• The chemical, physical and biological properties of the device and materials used in it must be appropriate, given its intended use;
• The device must be designed, produced and packaged in such a way that any risks of infection or contamination to a patient or any person involved in its use, transport or storage are minimized;
• The device’s design, construction and environmental properties must be appropriate with regard to its intended performance and any other device or equipment with which it is used, and the risks associated with leaching, ingress or egress of substances out of, or into, the device must be minimized;
• Devices with a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements (within the limits indicated by the manufacturer and having regard to the device’s intended purpose);
• The design and production of the device must minimize the risk of exposure of a patient, the user or any other person to radiation;
• Medical devices connected to or equipped with an energy source must be designed and produced in a way that minimizes electrical and other safety risks to patients, users and any other persons;
• The instructions and information provided with medical devices must be appropriate with regard to the device, its intended purpose and the training and knowledge of potential users of the device; and
• There must be clinical evidence, appropriate for the use and classification of the device, demonstrating that it complies with the applicable provisions of the essential principles.

The draft provides a plain English explanation of each essential principle and examples of ways in which manufacturers of medical devices may demonstrate compliance with each principle.

Instead of narrowly prescribing the evidence which manufacturers must provide, it is proposed that manufacturers may demonstrate that a medical device complies with the essential principles in a number of ways, including:

• a documented and detailed risk analysis;
• the results of testing the medical device;
• literature searches;
• a copy of the label and instructions for use demonstrating that information requirements have been met;
• an expert opinion; or
• a design dossier.

Effect on Manufacturers

Manufacturers should have already taken steps to ensure that any medical devices supplied in Australia are entered in the Register of Therapeutic Goods and comply with the Australian regulatory framework.

The stated intent of the new regulatory guidelines is to provide flexibility for sponsors and manufacturers of medical devices supplied in Australia and to cater for technological advances and changes by not dictating how a manufacturer must prove that it has met the essential principles.

It is hoped that the new regulatory guidelines will make it easier for manufacturers to understand and comply with the Australian regulatory framework for medical devices.

Manufacturers must comply with the requirements of the existing Therapeutic Goods Administration guidance material until it has been fully replaced by the regulatory guidelines.

For further information on this topic please contact Stuart Johnston, Moira Saville or Tania Noonan at Mallesons Stephen Jaques by telephone (+61 2 9296 2000) or by fax (+61 2 9296 3999) or by email (stuart.johnston@mallesons.com or moira.saville@mallesons.com or tania.noonan@mallesons.com).

Endnotes

(1) See www.tga.gov.au.