Australia – Therapeutic Goods Administration – TGA Medical Device Classification
TGA Medical Device Classification Rule 5 – Special Rules
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Rule 5.1 Devices incorporating a medicineThis rule covers medical devices that incorporate a medicinal substance including stable derivatives of human blood and blood plasma that assists the function of the device.
|5.1(2)A device incorporating a substance that if used separately would be a medicine and has an ancillary action on the body—Class III.|
Please note: for this clause any stable derivative of human blood or human plasma is considered to be a medicine.
|Examples: antibiotic bone cements, condoms with spermicide, heparin-coated catheters, dressings incorporating an antimicrobial agent where the purpose of such an agent is to provide ancillary action on the wound.|
Rule 5.2 Devices for contraception or prevention of sexually transmitted diseasesSome devices covered by this rule may perform both functions, for example, condoms.
|5.2(1)A device for contraception or the prevention of sexually transmitted diseases—Class IIb.||Examples: condoms, contraceptive diaphragms.|
An implantable or invasive device for long-term use—Class III.
|Examples: contraceptive intrauterine devices (IUDs), surgically implanted contraceptive devices.|
Rule 5.3 Devices intended for disinfecting, cleaning, rinsing, etc.(TGA Medical Device Classification)
This rule covers various contact lens fluids and substances or equipment to disinfect another medical device. It does not cover devices that clean by a physical action only.
|5.3(1)A device specifically for disinfecting, cleaning, rinsing or hydrating contact lenses—Class IIb.||Examples: contact lens solutions, comfort solutions.|
A device specifically for disinfecting another medical device—Class IIb.
Please note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class I (see Rule 2.1).
|Examples: disinfectants for haemodialysis devices or endoscopes, sterilizers to sterilize medical devices, washer disinfectors.|
Rule 5.4 Non-active devices intended to record x-ray diagnostic imagesA non-active medical device to record x-ray diagnostic images such as x-ray films, photo stimulable phosphor plates is Class IIa.
Rule 5.5 Devices containing non-viable animal tissues or derivatives, or microbial or recombinant tissues, cells or substances(TGA Medical Device Classification)
This rule covers devices that contain or are made of animal tissues that have been rendered non-viable or derivatives from such tissues also being non-viable, or microbial or recombinant tissues, cells or substances.
|5.5(1)(a)Devices that contain animal tissues or derivatives that have been rendered non-viable are Class III.|
Please note: this rule does not apply to a device that only contains animal tissues that have been rendered non-viable and the device is only intended by the manufacturer to come into contact with intact skin—see Rule 2.1.
|Examples: biological heart valves, porcine xenograft dressings, catgut sutures, implants, dressings made from collagen. Examples: leather straps associated with limb prostheses.|
|5.5(1)(a)Devices that contain tissues, cells or substances of microbial or recombinant origin are Class III, even if the device is only intended to come into contact with intact skin.||Examples: intra-ocular fluids, meniscal joint fluid replacement, anti-adhesion barriers, tissue fillers based on hyaluronic acid derived from bacterial fermentation processes.|
Rule 5.6 Devices that are blood bags(TGA Medical Device Classification)
|A device that is a blood bag is Class IIb.Please note: if the blood bags have a function greater than storing purposes and include systems for preservation other than anti-coagulants then other rules (for example, Rule 5.1) may apply.||Examples: blood bags (including those containing or coated with an anticoagulant).|
Rule 5.7 Active implantable medical devices
|5.7(1)An active implantable medical device is classified as Class AIMD||Example: pacemakers.|
|5.7(2)An implantable accessory to an active implantable medical device—Class III.||Example: electrode leads associated with pacemakers, defibrillators, nerve stimulators.|
|5.7(3)An active device to control, monitor or directly influence the performance of an active implantable medical device—Class III.||Example: clinician’s programming device for pacemakers, patient control device for nerve stimulation devices.|
Rule 5.8 Medical devices for export only(TGA Medical Device Classification)
A device that is intended by the manufacturer for export only is classified as Class I.
Rule 5.9 Devices that are mammary implantsA device that is a mammary implant is classified as Class III.
Information & Training.
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- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
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