Australian Therapeutic Goods Administration (TGA).
Classification Rule 3. Invasive Medical Devices
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Classification Rules 3.1 and 3.2—Invasive Medical Devices
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Rule 3.1 Invasive devices intended to be used to penetrate body orifices
This rule covers devices that enter the body through existing body orifices (for example, ear, mouth, nose, eye) and surgically created stomas. Devices covered by this rule tend to be for diagnostic and therapeutic use in particular specialities (ear, nose, and throat; ophthalmology; dentistry; proctology; urology; and gynaecology).
| Rule 3.1 | Description |
| 3.1(2)(a)Invasive devices that are not connected to an active medical device, and are for transient use—Class I. | Examples: handheld dental mirrors, dental impression materials, exam gloves, prostatic balloon dilation catheters. |
| 3.1(2)(b)(i)Invasive devices that are for short-term use—Class IIa. | Examples: contact lenses, urinary catheters, tracheal tubes, stents, vaginal pessaries, perineal reduction devices. |
| 3.1(2)(b)(ii)Invasive devices that are for short-term use in the oral cavity as far as the pharynx, in an ear canal to the ear drum, or in a nasal cavity—Class I. | Examples: dressing for nose bleeds, dentures removable by the patient. |
| 3.1(2)(c)(i)Invasive devices that are for long-term use—Class IIb. | Examples: long-term urinary catheters, artificial eyes, urethral stents. |
| 3.1(2)(c)(ii)Invasive devices for long-term use in the oral cavity as far as the pharynx or in an ear canal to the ear drum, or in a nasal cavity and are not liable to be absorbed by the mucous membrane—Class IIa. | Examples: orthodontic wire, fixed dental prostheses, fissures sealants. |
| 3.1(3)Invasive device to be connected to an active medical device that is classified as Class IIa or higher—Class IIa. | Examples: tracheostomy tubes connected to a ventilator, powered nasal irrigators, nasopharyngeal airways, heat and moisture exchangers, suction catheters or tubes for stomach drainage. |
Rule 3.2 Surgically invasive devices intended for transient use
This rule covers devices that are to be used continuously for less than 60 minutes and are used to create a conduit through the skin (needles, cannulae), surgical instruments (scalpels, saws) and various types of catheters, suckers.
| Rule 3.2 | Description |
| 3.2(2)Surgically invasive device for transient use—Class IIa. | Examples: suture needles, hypodermic needles and syringes, suckers, surgical swabs, surgical gloves. |
| 3.2(3) Surgically invasive device for transient use to diagnose, monitor, control or correct a defect of the heart, or central circulatory system through direct contact—Class III. | Examples: cardiovascular catheters, angioplasty balloon catheters, coronary artery probes. |
| 3.2(4) A reusable surgical instrument—Class I. | Examples: scissors, artery forceps, tissue forceps, tissue clamps, excavators, osteotomes, chisels. |
| 3.2(5)(a) A surgically invasive device for transient use to supply ionising radiation—Class IIb. | Examples: catheters containing or incorporating radioactive isotopes where the isotope is not intended to be released into the body. |
| 3.2(5)(b) A surgically invasive device for transient use to have a biological effect—Class IIb. | |
| 3.2(5)(c) A surgically invasive device for transient use to be wholly, or mostly, absorbed by the body—Class IIb. | Examples: bone wax. |
| 3.2(5)(d) A surgically invasive device for transient use to administer medicine via a delivery system, and where the administration is potentially hazardous to the patient—Class IIb. | Devices for repeated self-application where the dose and the medicine are critical. Examples: personal insulin injectors (commonly referred to as ‘pens’). |
Rule 3.3 Surgically invasive devices intended for short-term use
This rule covers devices to be used continuously for at least 60 minutes but not more than 30 days and are used in the context of surgery or post-operative care (for example, clamps and drains), infusion devices (cannulae and needles) and catheters of various types.
| Rule 3.3 | Description |
| 3.3(2)Surgically invasive device for short-term use—Class IIa. | Examples: clamps, infusion cannulae, skin closure devices or temporary filling materials, some surgical retractors for example, chest retractors for cardiac surgery. |
| 3.3(3)(a) A surgically invasive device for short-term use to supply ionising radiation—Class IIb. | Examples: brachytherapy devices. |
| 3.3(3)(b) A surgically invasive device for short-term use to undergo a chemical change in a patient’s body (except a device intended to be placed in the teeth)—Class IIb. | Examples: tissue adhesives. |
| 3.3(3)(c) A surgically invasive device for short-term use to administer medicine—Class IIb. | Examples: intravenous cannula. |
| 3.3(4)(a) A surgically invasive device for short-term use to be specifically used to diagnose, monitor, control or correct a defect of the heart, or central circulatory system, through direct contact with these parts of the body—Class III. | Examples: cardiovascular catheters, cardiac output probes and temporary pacemaker leads, thoracic catheters intended to drain the heart, including the pericardium and a carotid artery shunt. |
| 3.3(4)(b) A surgically invasive device for short-term use to be used in direct contact with the central nervous system—Class III. | Examples: neurological catheters, cortical electrodes, connonoid paddles. |
| 3.3(4)(c) and (d) A surgically invasive device for short-term use to have biological effect—Class III. | Examples: haemostatic sponge. |
| 3.3(4)(d) A surgically invasive device for short-term use to be wholly, or mostly, absorbed by a patient’s body—Class III. | Examples: absorbable sutures. |
| 3.3(5) A surgically invasive device for short-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body—Class IIa. Please note: for this clause, a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but that does not enter the gum or bone beyond the tooth. | Examples: dental adhesives used for root canal therapy. |
Rule 3.4 Surgically invasive devices for long-term use and implantable devices
Devices covered by this rule include implants used in orthopaedic, dental, ophthalmic and cardiovascular fields. In addition, soft tissue implants used in plastic surgery are covered by this rule.
| Rule 3.4 | Description |
| 3.4(2)A surgically invasive device for long-term use and implantable devices—Class IIb. | Examples: implantable joint replacements, shunts, stents, nails, plates and screws, intra-ocular lenses, infusion ports, peripheral vascular grafts, bone cements, maxillo-facial implants. |
| 3.4(3) A surgically invasive device for long-term use to be placed in the teeth—Class IIa. | Examples: bridges and crowns. |
| 3.4(4)(a) A surgically invasive device for long-term use to be used in direct contact with the heart, the central circulatory system or the central nervous system—Class III. | Examples: prosthetic heart valves, aneurysm clips, vascular prostheses, spinal stents, vascular stents, CNS electrodes, cardiovascular sutures. |
| 3.4(4)(b) A surgically invasive device for long-term use intended by the manufacturer to have a biological effect—Class III. | |
| 3.4(4)(c) A surgically invasive device for long-term use to be wholly, or mostly, absorbed by a patient’s body—Class III. | Examples: absorbable sutures, bioactive adhesives and implants through the attachment of surface coatings such as phosphorylcholine. |
| 3.4(4)(d) A surgically invasive device for long-term use to undergo a chemical change in the patient’s body (except a device that is to be placed in the teeth)—Class III. | Examples: surgical adhesive. |
| 3.4(4)(e) A surgically invasive device for long-term use to administer medicine—Class III. | Examples: rechargeable non-active drug delivery systems. |
| 3.4(5) A surgically invasive device for long-term use that is intended by the manufacturer to be placed in the teeth and to undergo a chemical change in the body is Class IIa. Please note: for this rule a medical device to be placed in the teeth includes a device that is intended to penetrate a tooth but does not enter the gum or bone beyond the tooth. | Examples: dentine adhesives. |
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