Dear stakeholder

The purpose of this letter is to remind you that from 4 October 2004, some previously excluded devices will be regulated as medical devices under the Therapeutic Goods Act 1989 (see attachment 1 for examples).

Background

On 4 October 2002 the TGA implemented a new regulatory system for medical devices. Australia's new medical devices regulatory system is based on:

• a set of risk based classification rules by which medical devices are classified into one of five categories, Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), Class III (high risk), and Active Implantable Medical Device (high risk);
• a set of essential principles for safety and performance that must be met by all medical devices;
• conformity assessment procedures used to demonstrate medical devices conform with the essential principles;
• a requirement for manufacturers of medical devices to have a quality management system in place for the manufacture of medical devices. This quality management system has to be assessed by an external regulatory agency for all devices, except the lowest risk category (Class I non-sterile and non-measuring);
• the presumption that a medical device conforms with the essential principles if compliance with nominated harmonised standards can be demonstrated; and
• post-market monitoring by both the manufacturer/sponsor and the TGA.

The transitional arrangements for the implementation of the new regulatory system included a two year transition period for devices that met the definition of a medical device but were excluded under the Therapeutic Goods (Excluded Goods) Order of 1998 (the Order).

The two-year transition period for excluded goods ends on 4 October 2004. All previously excluded products that meet the definition of a medical device will have to be included on the Australian Register of Therapeutic Goods (ARTG) and meet the above requirements.

Amendments to the Excluded Goods Order

On 4 October 2004 the Therapeutic Goods (Excluded Goods) Order of 1998 (Excluded Goods Order) will be repealed and replaced with the Therapeutic Goods (Excluded Goods) Order No. 1 of 2004. The key changes in relation to previously excluded medical devices are the removal of the following clauses:

• Clause 3(k) "non-implantable devices, equipment or apparel intended for use in: improving comfort, enhancing relaxation, exercising or improving physiological fitness, modifying anatomical physique, improving appearance, muscle or skin tone, easing minor aches and pains, fatigue or tiredness (due to normal ageing or day to day activities), or stimulating circulation (via exercise or the application of heat or massage";
• Clause 3(p) "non-invasive locators of, or stimulators for, "acupoints" or "energy meridians"";
• Clause 3(q) "devices that emit, measure or absorb, or claim to emit measure or absorb, vibrations, waves, particles or energy for which health benefit claims are made, the principles of which have not been scientifically validated"; and
• Clause 4(9) "Jewellery and objects or adornments with reputed remedial or therapeutic powers".

This means that where these products fit the definition of a medical device, ie a manufacturer makes therapeutic claims for these devices they will be regulated as medical devices.

Manufacturers of medical devices to which the above clauses apply, will be required to undertake the relevant conformity assessment procedures for manufacturing under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 and demonstrate their medical devices meet the Essential Principles for safety and performance. Sponsors will need to include the medical devices on the ARTG.

Aids for the disabled

Aids for the disabled is a very broad category of devices, many of which are custom made, ranging from modified household utensils, such as bent spoons, to sophisticated computerised technologies. Intensive TGA regulation of many very low risk products would be unwarranted and intrusive with little benefit to the safety of the user. However, the need for all such products to meet basic safety and performance criteria embodied in the essential principles is generally accepted by the sector.

The issue requires further discussion and development before it can be progressed. The 2004 Order therefore retains the current exclusion for "household and personal aids, or furniture and utensils, for people with disabilities" until further industry consultation can occur.

Recommended action

Sponsors and manufacturers of goods affected by these changes need to contact the TGA for advice and assistance regarding the regulatory requirements for medical devices and submit applications to include the goods onto the ARTG.

Further information and guidance documents are available on the TGA website at www.tga.gov.au/devices/devices.htm or the medical devices information line on 1800 141 144.

Yours sincerely

Peter Liehne
Assistant Secretary
Medical Devices
September 2004

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Attachment 1

Some examples of medical devices which are currently in the Excluded Goods Order but which will fall into Class I once the Order is amended are:

Excluded
Acupuncture pressure point equipment
Jewellery with reputed remedial or therapeutic powers
Magnetic therapy equipment
Multi-wave oscillation equipment
Electrodermal screening equipment
Crystal therapy devices
Ionising devices
Electric current therapy equipment
Sound frequency therapy equipment
Thermographic therapy equipment