Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991

This Order is also known as Appendix 19 of DR4*.

*On 4 October 2002 a new regulatory system was implemented for medical devices under the Therapeutic Goods Act 1989. DR4 is the guidance document for the old regulatory system for therapeutic devices. DR4 is still applicable to: Devices incorporating human materials; Hospital, household and commercial grade disinfectants; Menstrual tampons; Devices that remain on the ARTG under the old system. DR4 is of no relevance to medical devices regulated under the new system. Therefore any new devices to be marketed in Australia will have to meet the new requirements, excluding the above-mentioned devices.

Commonwealth of Australia

Therapeutic Goods Act 1989

Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991

STG1/1991

[This copy of the Order incorporates amendments made in August 1992 by the Therapeutic Goods (Groups) Order No. 1 of 1992]

I, STUART HAMILTON, Secretary to the Department of Community Services and Health, make the following Order under subsections 16 (2) and (3) of the Therapeutic Goods Act 1989 and section 4 of the Acts Interpretation Act 1901.

Dated 15th February 1991

Secretary

Citation

1. This Order may be cited as the Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991.

Commencement

2. This Order commences on the day that the Therapeutic Goods Act 1989 commences.

Interpretation

3. In this Order, unless the contrary intention appears:

• "accessories", in relation to powered drug infusion systems, include infusion sets, drip detectors and power sources;
• "Australian Device Group" means the therapeutic devices classified as a group in the publication "Australian Device Groups":
  1. published by, and available from, the Department of Community Services and Health; and
  2. as in force on the day on which this order commences;
• "design parameters", in relation to an intraocular lens, are the following parameters of change for both a right or left handed version of the same model of lens
  1. a change in overall lens diameter in the range +/- 1.0mm or addition of a new overall size in the range +/- 1.0mm to a series of sizes available under a model designation where the changes are between an upper limit of 14.5mm and a lower limit of 11.0mm (ciliary sulcus fixation) or 10.5mm (capsular sac fixation);
  2. the addition of notches, loops or rounded ends to haptics;
  3. a change in haptic angulation, in the range 0 to 10 degrees (optic angulated posterior to the haptics);
  4. a change in haptic configuration, material or calibre that has no significant effect on the mechanical properties of the lens if the change is verified by relevant tests that include:
     1. decentration; and
     2. compression force; and
     3. compressed tilt; and
     4. optical tilt; and
     5. compression force decay; and
     6. compressed contact area;
  5. a change in the dioptric power range in the range +4 to +34 dioptres;
  6. a change in the optic diameter, resulting in an increase of 2mm or less (up to 7.5mm) or a decrease of 2mm or less (down to 5.5mm);
  7. the addition, deletion or moving or position holes of the optic - unless they infringe on the central 4.25mm of the optic;
  8. the addition of a ridge on the posterior surface of the optic (unless the ridge infringes on the central 4.25mm of the optic) or modification of optic for weight reduction purposes;
  9. a change in the optic shape factor or a change in the optic circumference from circular to another shape that is not the first change of that type.
• "diagnostic goods for in vitro use" has the same meaning as in the Regulations;
• "formulated therapeutic devices" are therapeutic goods presented in dosage form and recognised as therapeutic devices for the principal purpose of their use;
• "human origin", in relation to diagnostic goods for in vitro use, means that the devices contain, or are manufactured using, material or substances derived from human tissues;
• "implantable", in relation to therapeutic devices, means that the device is designed to be implanted into the tissues or body cavities of a person, other than the teeth, for a period not less than 30 days;
• "implantable cardiac pacing system leads" means leads that are accessories to implantable pulse generators, implantable defibrillators, implantable cardioverters or implantable antitachycardia devices;
• "intraocular lens" means an implantable device used to replace or augment the natural lens inside the eye for the purpose of improving the optical performance of the eye;
• "listed" means listed in the Australian Register of Therapeutic Goods maintained under section 17 of the Act;
• "medicated therapeutic device" means a therapeutic device that is represented to achieve, or is likely to achieve, a purpose of its use, but not the principal purpose of its use, as a result of chemical action in or on the body of a person;
• "parent lens" means a registered intraocular lens from which a modified lens is derived;
• "powered drug infusion system" means powered equipment for the purpose of administering to humans by controlled automatic means, a flow of therapeutic substances over a period of time but does not include:
  1. simple and metered dose syringes; or
  2. infusion giving sets that do not have an automatic means of controlling delivery; or
  3. renal dialysis systems; or
  4. extracorporeal bypass systems;
• "principal manufacturer" means the manufacturer who carries out the total manufacture of a product or, if more than one manufacturer is involved, the manufacturer nominated by the sponsor to be the principal manufacturer;
• "prosthetic heart valve" means an implantable device that replaces a defective natural heart valve and is intended to preserve the cardiac valve functions;
• "registered" means registered in the Australian Register of Therapeutic Goods maintained under section 17 of the Act;
• "the Act" means the Therapeutic Goods Act 1989;
• "therapeutic devices of human or animal origin" means therapeutic devices (other than denatured coral products) that:
  1. contain or are manufactured using material or substances derived from human or animal tissues; and
  2. are intended for use in or on the body of a person;
• "the Regulations" means the Therapeutic Goods Regulations.

Therapeutic goods that are to be treated as single therapeutic goods

4.

[Clauses 4(1), 4(2), 4(3) and 4(4) were deleted by Therapeutic Goods (Groups) Order No. 1 of 1992]

• (5) Therapeutic devices that:

  1. are eligible to be listed; and
  2. are not diagnostic goods for in vitro use:
     1. that are for home use; or
     2. that are supplied as pharmaceutical benefits; or
     3. that are for use in the diagnosis of infection with Human Immunodeficiency Virus; and
  3. have the following characteristics or circumstances in common:
     1. the sponsor; and
     2. the principal manufacturer; and
     3. classification in the same Australian Device Group; and
     4. supply in the same state of sterility, whether sterile or non-sterile; and
  4. are not subject to different standards; and
  5. if the devices are medicated therapeutic devices - contain the same therapeutically active components in their final formulation; and
  6. if the devices are formulated therapeutic devices - contain the same principal substance upon which the action of the devices depend;

  are to be treated as single therapeutic goods for the purposes of Part 3 of the Act.

• (6) Therapeutic devices that:

  1. are eligible to be registered; and
  2. have the same sponsor; and
  3. have the same principal manufacturer; and
  4. are classified in the same Australian Device Group; and
  5. if the therapeutic devices are implantable polymethylmethacrylate posterior chamber intraocular lenses - have the same composition and do not differ by more than the specified design parameters in relation to a parent lens; and
  6. if the therapeutic devices are implantable cardiac pacing system leads, including leads for pulse generators, defibrillators, cardioverters, and antitachycardia devices - differ only in the length of the leads; and
  7. if the therapeutic devices are prosthetic heart valves - differ only in the size of the valves; and
  8. if the therapeutic devices are of human or animal origin - differ only in size;

  are to be treated as single therapeutic goods for the purposes of Part 3 of the Act.

• (7) Therapeutic goods that are:

  1. eligible to be registered; and
  2. a powered drug infusion system; and therapeutic goods that are:
  3. eligible to be registered; and
  4. accessories of the powered drug infusion system referred to in paragraph (7)(b);

  are to be treated as single therapeutic goods for the purposes of Part 3 of the Act if the system and the accessories:

  5. have the same sponsor; and
  6. have the same principal manufacturer; and
  7. are classified in the same Australian Device Group