Updated: 09/25/02

Australia introduces a new regulatory system.

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Introduction

The Australian medical devices industry plays an important role in Australia's health sector and in 2001 was a US$1.1 billion industry. Australia is among the world leaders in ensuring high standard international regulation and is one of the five members of the Global Harmonization Task Force (GHTF) for medical devices along with the U.S., Canada, the European Union and Japan.

A formal arrangement for regulating medical devices commenced in Australia in 1987 in response to concerns about the many medical devices coming onto the market as a result of technological advances and the increasing role of devices in health care. Before any medical device can be supplied in Australia, details must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA). There are approximately 24,000 product entries in the ARTG for medical devices. The Therapeutic Goods Act of 1989 regulates the supply of therapeutic goods in Australia, with the intention of protecting health care workers and the Australian public by ensuring the safety, quality and efficacy of therapeutic goods used in Australia, whether the goods are produced in Australia or elsewhere.

Companies should be aware that a new harmonized system governing the supply of medical devices in Australia will come into effect from October 5, 2002. After that time, all new medical devices will be required to comply with the new harmonized requirements, except a small group of products (which will have until October 4, 2004, to meet the new requirements).

This new regulatory system is based on the guidelines of the Global Harmonization Task Force (GHTF) and the European Community (EC) requirements, and will directly affect Australian importers, exporters and manufacturers of medical devices. More details on these changes are included below.

Current System

Under Australia's current regulatory system (http://www.health.gov.au/tga/docs/html/dr4.htm), all medical devices made available for sale in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) as either "registrable" or "listable" devices (see below), unless specifically exempted. Medical devices fall into three categories for purposes of inclusion in the ARTG: registrable, listable and exempt. Medical devices considered critical, such as cardiac pacemakers, powered drug infusion systems, and HIV and hepatitis C in vitro diagnostic kits, are REGISTRABLE devices. These products are evaluated comprehensively for their quality, safety and efficacy before they are permitted to be supplied on Australia's market. Most other devices are LISTABLE, and are given a briefer assessment to check conformity to manufacturing, labeling and quality standards.

In the case of U.S. companies wishing to supply the Australian market, an Australian sponsor must make application to the TGA on their behalf. This sponsor is usually the distributor. Once a product is listed on the ARTG, sponsorship can be transferred, if required. For example, if a U.S. company wishes to change from Distributor A, who had been the sponsoring company for registration on the ARTG, to Distributor B, then a transfer of sponsorship form would need to be completed. This may not be done without the knowledge of Distributor A. The change of sponsor process does not affect the listing or registration of the product on the ARTG.

The TGA has a monopoly on assessing compliance with the legislation, and is required to cover some costs through fees and charges to industry. Schedules of application fees can be obtained from the TGA's website.

Good Manufacturing Practices

The Therapeutic Goods Act requires that the standard of manufacture of imported products be taken into consideration for registration and listing. Under the Act, the term "manufacture" includes all or any of the steps of compounding, processing, assembling, packaging, labeling, sterilization, testing and release for sale. The sponsor can either supply an "acceptable form of evidence" or agree to pay the costs of an Australian auditor, if Good Manufacturing Practice (GMP) audit is considered necessary. For therapeutic goods (or components thereof) imported into Australia, the TGA recognizes suitable certification resulting from other countries GMP audits as equivalent TGA certification.

For U.S. manufacturers, evidence of an acceptable U.S. FDA audit may be submitted (note: the inspection must have been a "full" FDA establishment inspection, and must have been completed within the past three years); or a current Device Manufacturers License issued by the Food and Drug Branch of the California Department of Health. The TGA's website (see below) contains extensive information on GMP requirements and prospective suppliers to the Australian market are advised to review this material.

As many applications for listing or registration on the ARTG are either delayed or rejected due to inadequate evidence of GMP compliance, the TGA has enabled sponsors to request a clearance assessment of the GMP evidence for an overseas manufacturer prior to actually submitting an application. This involves submission of a clearance form for each manufacturing site. A fee may be payable for this service, if the GMP Audit and Licensing Section is required to liaise with other overseas bodies to confirm the status of the manufacturer. This completed form, with the GMP Audit and Licensing Section ruling on its acceptability, may then be submitted as part of an application by the sponsor as evidence of GMP compliance.

Listing or Registration Applications

The application for listable or registrable therapeutic devices (valid for original submissions or modifications) can be obtained from TGA's website at link http://www.health.gov.au/tga/docs/pdf/devform.pdf. In addition, an Enterprise Details Form should be completed by or for each enterprise in cases where the application is the enterprise's first in Australia, or its address or authorized representatives have changed since the previous application (the Enterprise Details Form may accompany applications for registration, listing or clinical trial, or may be sent separately). Applications are assigned to the TGA's Business Management Unit, and are assigned a Therapeutic Goods Application Identification Number (TGAIN), which should be cited in any inquiries concerning a particular application.

Clinical Trials

Where required (as in the case of certain registrable devices), clinical investigations must conform to standards set forth in the World Medical Association's Helsinki Declaration on clinical research involving human subjects. Resulting data must be presented in accordance with ISO 14155.

Labeling

Labels must be in English and must include the name of the therapeutic device; the name and address of the manufacturer or sponsor; the batch and serial number; and (for devices packaged with other devices or substances) the name and quantity of the other goods or substances included in the same package with the subject device. (Labeling requirements are modified accordingly for sterile devices and implantable devices).

Coming Soon - Proposed New Harmonized Regulatory System

The new harmonized system governing the supply of medical devices in Australia will come into effect from October 5, 2002. After that time, all new medical devices will be required to comply with the new harmonized requirements, except a small group of products. Products that are currently exempt will have until October 4, 2004, to meet the new requirements. To reduce confusion, during the transition period devices introduced to the market under the current system will be denoted as "therapeutic devices," while those introduced under the new system will be referred to as "medical devices."

The purpose of the change is to harmonize the Australian system with international regulatory practices. Legislation to amend the Therapeutic Goods Act was introduced in the Australian Parliament in March 2001. The bill incorporates principles of safety, performance, and vigilance, as recommended by the Global Harmonization Task Force for medical devices (of which Australia is a member, along with the United States, Canada, the European Union and Japan). Australia's 1998 Mutual Recognition Agreement with the European Union has led the way toward a more "harmonized" regulatory system, and the new Australian regulatory model incorporates elements of EU regulatory requirements, although not the EU's private sector ("Third Party") evaluation system. While major elements of the current legislation will be retained, the changes will introduce different medical device classifications and pre-market assessment requirements.

The proposed new system includes:

Expression of the essential requirements for medical devices;

Some minimum requirements for "exempt" Class I devices;

A more comprehensive pre-market assessment of new technologies, high-risk active devices and implantable devices;

Greater reliance on international standards; and

More powerful mechanisms for requiring sponsors to monitor report device problems, with greater emphasis on post-market activities, such as vigilance.

Periodic inspections of manufacturers' quality systems and labeling and advertising requirements are not expected to change significantly from the current system. The new system will facilitate the electronic entry of applications for inclusion of devices in the ARTG, using the new Device Electronic Application Lodgement system (DEAL). The main changes relate to medical device classification, pre-market assessment requirements and post-market device problem reporting.

a) Device Classification

Under the soon to be implemented regulatory regime (see below for more details), most medical devices will be classified into one of five classes: Classes I, IIa, IIb, III and Active Implantable Medical Devices (AIMDs). As of this writing, the placement of in-vitro diagnostic medical devices in the new system is still under consideration.

Many devices classified "exempt" from inclusion in the ARTG under the current regime will become Class I (for example, non-powered hospital furniture and simple non-sterile, non-powered surgical and dental instruments). In addition, some devices, classified "listable" under the current regime (such as thermometers, gauze dressings and stethoscopes), will also become Class I devices. Other "listable" medical devices (such as hearing aids, dental filling materials and oxygen meters) will become Class IIa devices. Higher-risk devices, including some classified "listable" and most of those classified "registrable" under the current system, will become Class IIb and III devices.

All classes will be required to demonstrate conformity with safety and performance requirements. Class IIa, IIb, III and AIMD devices will require quality systems verification. Class III devices and AIMDs will be subject to the most extensive pre-market assessments.

A brief description of the five new classes follows:

Class I - Low risk: These devices are non-invasive & simple or invasive & transient use/reusable, etc., e.g., stethoscopes, examination gloves, dentures, wound dressings and simple surgical implements.

Class II - Intermediate risk: Devices in this class are subdivided into Class IIa and Class IIb, depending on the level of invasiveness.

Class IIa devices are non-invasive for channeling or body fluid modifiers; special dressing; invasive & short term use; diagnostic active; device hospital and household/ commercial grade disinfectants, e.g., infusion tubing, polymer film dressing, urinary catheters, suture needles.

Class IIb devices include 'healing' wound dressings; surgically invasive; implantable; active; contraceptives; blood bags, etc., e.g., hemodialysers, insulin pens, bone cement, intra-ocular lenses, anaesthetic machines.

Class III - High risk: These devices include the surgically invasive, including medicine and animal-derived products, e.g., all active implantable devices, cardiovascular catheters, absorbable sutures, heart valves and collagen implants.

AIMD - Active implantable medical devices, equivalent to in risk to Class III.

Further information on the classification rules can be obtained from the TGA website: http://www.health.gov.au/tga/docs/html/devregdr.htm. These Australian rules are similar to the EC rules.

Provision will be made for applications for entry on the ARTG to be lodged electronically using the Device Electronic Application Lodgement system (DEAL). All medical devices currently approved for use in Australia will have five years (until October 4, 2007) to comply with the new requirements.

b) Premarket Assessment

The ARTG will remain the central point of control for the legal supply of medical devices. Medical device in all classes will comply with a minimum requirement for safety and performance, and will be included in the ARTG. The level of assessment is commensurate with the level and nature of the risks posed to consumers. Class IIa, IIb, III and AIMD devices will require quality systems. Class III devices and AIMD will be subject to the most extensive premarket assessment in the new system. Class I devices will be subject to manufacturer self-assessment, while Class III devices will require TGA assessment. (Note: Under the current system, less than 5% of devices are registrable and thus subject to detailed pre-market evaluation for quality, safety and efficacy.)

c) Postmarket Requirements

The postmarket requirements regarding medical devices have been expanded under the new system. These requirements address the following:

Evidence of conformity;

Manufacture (with manufacturers assessed for conformance via a manufacturing quality system, subject to verification via periodic inspections);

Labeling and standards (failure to comply with essential requirements renders a product liable to be withdrawn by the regulatory authority);

Vigilance system (mandatory reporting system for all events associated with the performance of a device leading to death or serious deterioration in the health of a patient or user).

Sponsors must advise the TGA of serious device incidents within 10 days and non-serious incidents within 30 days. As is the case now, the responsibility for the safety and performance of medical devices will remain with the sponsors and manufacturers.

In addition, there will be new requirements regarding device tracking, which is not currently covered in the Therapeutic Goods Act 1989. There will be provision made in the legislation to track specific high-risk devices to the hospital level. Devices to be tracked are yet to be determined, but could include such items as active implantable cardiac devices, prosthetic heart valves, silicone gel-filled prostheses and implantable devices of biological origin.

Further information can be obtained from the TGA website: http://www.health.gov.au/tga/devices/devices.htm

Contacts

Therapeutic Goods Administration: For detailed information on medical regulations and the Therapeutic Goods Administration, including downloadable forms and information on the new regulatory regime, U. S. firms may wish to visit the medical device page of the Therapeutic Goods Administration website at http://www.health.gov.au/tga/devices/devices.htm; or contact:

The Information Officer
Conformity Assessment Branch
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia
Tel: 61-2-6232-8438
61-2-6232-8686 (inquiries regarding status of medical device listing applications)
61-2-6232-8777 (inquiries regarding status of medical device registration applications)
Fax: 61-2-6232-8676
Email: cab.medical.device.information@health.gov.au

Standards: Australian standard specifications and codes provide the basis for uniformity in design, safety, performance, purchase and application of equipment in health care facilities and institutions. In line with Standards Australia policy, these standards are based to the maximum extent possible on relevant international standards and take account of safe practices well established in Australia. Details on Australian Standards may be obtained from:

Standards Australia
PO Box 1055
Strathfield NSW 2315
Australia
Tel: 61-2-9746-4700
Fax: 61-2-9746-8450
Website: www.standards.com.au

Health Statistics: The Australian Institute of Health and Welfare is Australia's national agency for health and welfare statistics and information. The Institute works with many government and non-government bodies across the nation to generate reliable, regular and current facts and figures on the health and welfare of Australians. It publishes reports and discussion papers, drawing on a wide range of data collections, and also develops and publishes standards and classifications for health and welfare statistics.

Australian Institute of Health and Welfare
6A Traeger Court, Fern Hill Park, Bruce ACT, Australia
GPO Box 570, Canberra ACT Australia 2601
Tel: 61-2-6244-1000
Fax: 61-2-6244-1299
website: www.aihw.gov.au

The U.S. Commercial Service in Australia
Contact: Ms. Monique Roos, Commercial Specialist
Level 59, MLC Centre, 19-29 Martin Place
Sydney NSW 2000
Australia
Tel: 61-2-9373-9210
Fax: 61-2-9221-0573
Email: monique.roos@mail.doc.gov
Website: www.commercialservice.com/australia