an active medical device (other than an implantable medical device) that is intended by the manufacturer:

1. either:
   1. to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
   2. to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
2. to remain in place after the procedure.

1. a medical device that is intended by the manufacturer:
   1. to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and
   2. to act by converting this energy; but
2. does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted

a substance:

1. that is recommended by its manufacturer for:
   1. dermal application; or
   2. application to the mucous membranes of a person or an animal:
      1. to kill micro organisms; or
      2. to prevent the growth of micro organisms to a level that causes or may cause clinical infection; and
2. that is not represented to be suitable for internal use.

a quantity of a product that is:

1. uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
2. made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle

therapeutic goods consisting wholly or principally of one or more designated active ingredients, each or which has a clearly established identity and

1. a traditional use OR
2. any other use prescribed in the regulations

Schedule 14 of the Therapeutic Goods Regulations 1990 defines the following as 'designated active ingredients':

1. an amino acid
2. charcoal
3. a choline salt
4. an essential oil
5. plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
6. a homoeopathic preparation
7. a microorganism, whole or extracted, except a vaccine
8. a mineral including a mineral salt and a naturally occurring mineral
9. a mucopolysaccharide
10. non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
11. a lipid, including an essential fatty acid or phospholipid
12. a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
13. a sugar, polysaccharide or carbohydrate
14. a vitamin or provitamin

a medicinal product where the primary pack or the container includes at least two kinds of medicinal products and does not contain any medical devices. The medicinal products must be for use as a single treatment or as a single course of treatment, and it is necessary that the medicines be combined before administration or that they must be administered in a particular sequence

Examples:

• a strip or blister pack containing tablets or capsules with differing formulations to be taken in a specified order
• a primary pack containing an active ingredient in one vial and a diluent in another vial
• a primary pack containing separate containers of different formulations for use as part of a single regimen of treatment

a medical device that:

1. is specifically made in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and
2. is intended to be used only in relation to a particular individual

includes information on:

1. appropriate uses of the therapeutic goods
2. the method of administration or use of the goods
3. the frequency and duration of treatment for each indication of the goods
4. the use of the goods by persons of particular ages or by persons having particular medical conditions

a substance:

1. that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
2. that is not represented by the manufacturer to be suitable for internal use

medicine that:

1. is manufactured in Australia for export only, or imported into Australia for export only; and
2. is listable goods only because it is so manufactured or imported (and not for any other reason)

a medicine that, in comparison to a registered medicine:

1. has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine; and
2. has the same pharmaceutical form; and
3. is bioequivalent; and
4. has the same safety and efficacy properties

all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):

1. that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and
2. that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form

a preparation:

1. formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and
2. prepared according to the practices of homoeopathic pharmacy using the methods of:
   1. serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or
   2. serial trituration in lactose

(also see Homoeopathic preparations)

a medical device (other than an active implantable medical device) that is intended by the manufacturer:

1. to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
2. to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
3. to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure

in relation to a medical device to which Chapter 4 of the Therapeutic Goods Act 1989 applies, means included in the ARTG

Note: For medical devices to which Chapter 4 applies, see section 41BJ of the Act.

of a kind of medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:

1. the information provided with the device; or
2. the instructions for use of the device; or
3. any advertising material applying to the device

Kits are listed as either medicine or device kits. A package and therapeutic goods in the package together constitute a kit for the purposes of the Therapeutic Goods Act 1989 if:

1. the package and the therapeutic goods are for use as a unit; and
2. each item of the therapeutic goods consists of goods that are registered or listed or are exempt goods in relation to Part 3-2; and
3. the package and therapeutic goods do not constitute a composite pack or a system or procedure pack.

also see Medical devices packaged together

means a display of printed information:

1. on or attached to the goods; or
2. on or attached to a container or primary pack in which the goods are supplied; or
3. supplied with such a container or pack

In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement.

To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles which includes relevant Codes of GMP and Quality Systems.

1. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations.
2. If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person's name, does one or more of the following using ready-made products:
   1. assembles the device;
   2. packages the device;
   3. processes the device;
   4. fully refurbishes the device;
   5. labels the device;
   6. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:
      1. the labelling on the device;
      2. the instructions for using the device;
      3. any advertising material relating to the device.
3. However, a person is not the manufacturer of a medical device if:
   1. the person assembles or adapts the device for an individual patient; and
   2. the device has already been supplied by another person; and
   3. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:
      1. the labelling on the device;
      2. the instructions for using the device;
      3. any advertising material relating to the device.

• Certificate of GMP Compliance
• GMP Certificate of Manufacturing Facility
• Certificate of GMP Compliance of a Manufacturer

1. therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal
2. any other therapeutic goods declared by the Secretary, for the purposes of the definition of therapeutic device, not to be therapeutic devices

also see Summary classification of medicines

is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device

Refurbishment of a medical device may involve the following actions:

• stripping the device into component parts or sub assemblies
• checking parts of the device for suitability for reuse
• replacing component parts or sub assemblies of the device that are not suitable for reuse
• assembling reclaimed or replacement component parts or sub assemblies of the device or another used device
• testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications
• identifying an assembled device as a refurbished device

refers to one or more of the following activities carried out on single use devices to supply for reuse:

• Assembly the device; or
• Packaging the device; or
• Processing the device; or
• Fully refurbishing the device; or
• Labelling the device; or
• Assigning the device a new intended purpose by means of information supplied by on or in the labelling; the instructions for use or advertising material

In the process, the person responsible for undertaking these activities on a single use device has:

• Changed the intended purpose of the device;
• Certified the device is suitable for reuse; and
• Assumed the legal liability for the quality, safety and performance of the device

means the medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used on another patient.

Some single-use devices are marketed as non-sterile which require processing to make them sterile and ready for use. The manufacturer of the device will include appropriate processing instructions to make it ready for use

in relation to an advertisement or generic information, means:

1. mainstream media within the meaning of Section 42B of the Act OR
2. cinematograph films OR
3. displays about goods, including posters
   1. in shopping malls (except inside an individual shop)
   2. in or on public transport
   3. on billboards

in relation to therapeutic goods, means:

1. a person who exports, or arranges the exportation of, the goods from Australia; or
2. a person who imports, or arranges the importation of, the goods into Australia; or
3. a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

4. exports, imports or manufactures the goods; or
5. arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

therapeutic goods are tampered with if:

1. they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
2. the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

Manufacturing Technical Expert Reference Group. There are six reference groups:

• Blood and Tissues Manufacturing Technical Expert Reference Group
• Complementary Medicines Technical Expert Reference Group
• Medical Devices Technical Expert Reference Group
• Non-Sterile Medicines Technical Expert Reference Group
• Pharmacy Manufacturing Technical Expert Reference Group
• Sterile Medicines Technical Expert Reference Group

For medical devices that are supplied sterile:

• the device has been placed into a wound or body cavity and comes into contact with blood or body fluids; or
• has been opened but cannot be reprocessed because the manufacturer did not provide instructions on how to reprocess the device if the package is opened or damaged.

For medical devices that are supplied non-sterile:

• the device has been applied for its intended purpose.

of a patient, means a process that is necessary to sustain life and the indicators of which may include any 1 or more of the following:

1. respiration
2. heart rate
3. cerebral function
4. blood gases
5. blood pressure
6. body temperature