Australia – Therapeutic Goods Agency.
Classification Rule 4 – Active Medical Devices
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An active medical device is defined in the Therapeutic Goods (Medical Devices) Regulations 2002 as being a medical device that is intended by the manufacturer:– to depend on 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
– to act by converting this energy; but
– 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.
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Rule 4.1 Active medical devices—general
This rule applies to active medical devices that are not covered by a specific rule.| Rule 4.1 | Description |
| An active device is Class I, unless the device is classified at a higher level under another rule in Schedule 2 of the Regulations. | Examples: examination lights, surgical microscopes, diagnostic devices for thermography, active devices for recording, processing or viewing of diagnostic images, dental curing lights. |
Rule 4.2 Active medical devices for therapy
Active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or disability.This rule covers devices that are electrical equipment used in surgery, devices used in specialized treatments and stimulation devices.
| Rule 4.2 | Description |
| 4.2(1)An activemedical device for therapy to administer energy to a patient, or exchange energy to or from a patient—Class IIa. | Examples: electrical—magnetic and electromagnetic energy muscle stimulators, external bone growth stimulators, TENS devices, electrical acupuncture thermal energy—cryosurgery equipment, heat exchangers mechanical energy—powered dermatomes, drills and dental hand pieces light—phototherapy for skin treatment and for neonatal care sound—hearing aids. |
| 4.2(2)An active device to administer or exchange energy in a potentially hazardous way, having regard to the nature, density and site of application of the energy—Class IIb. | Examples: kinetic energy—lung ventilators thermal energy—infant incubators, warming blankets for unconscious patients, blood warmers, heat exchangers used in intensive care electrical energy—high-frequency electrosurgical generators, electrocautery, external defibrillators, electroconvulsive therapy equipment coherent light—surgical lasers ultrasound—lithotriptors, physiotherapy ultrasound devices ionizing radiation—radioactive sources for after-loading therapy, therapeutic cyclotrons, linear accelerators, therapeutic X-ray sources. |
| 4.2(3)An active device to control or monitor, or directly influence the performance of an active medical device for therapy of the kind in the previous entry—Class IIb. | Examples: external feedback systems for active therapeutic devices, after-loading control devices. |
Rule 4.3 Active medical devices for diagnosis
Active medical device for diagnosis means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to supply information for the purpose of detecting, diagnosing, monitoring or treating physiological conditions, states of health, illness or congenital deformities.This rule covers devices that are used in ultrasound diagnosis and capture of physiological signals and devices used in diagnostic radiology.
Please note: Active devices for diagnosis are classified as Class I, in accordance with Rule 4.1, unless they are specifically covered by any of the clauses in Rule 4.3.
| Rule 4.3 | Description |
| 4.3(2)(a)A device to supply energy that will be absorbed by a patient’s body (except a device that illuminates the patient’s body in the visible spectrum)—Class IIa. | Examples: magnetic resonance equipment, pulp testers, evoked response stimulators, diagnostic ultrasound. |
| 4.3(2)(b)A device to be used to image in vivo distribution of radiopharmaceuticals in patients—Class IIa. | Examples: gamma cameras, positron emission tomography, single photon emission computer tomography. |
| 4.3(2)(c) A device used for direct diagnosis or monitoring of vital physiological processes of a patient, excluding devices mentioned in the previous entry—Class IIa. | Examples: electrocardiographs, electroencephalographs, cardioscopes with or without pacing pulse indicators, electronic thermometers. |
| 4.3(3)(a)A device to monitor vital physiological parameters of a patient, and the nature of variations monitored could result in immediate danger to the patient—Class IIb. Please note: For this clause ‘variations monitored’, is taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm. | Examples: intensive care monitoring systems, biological sensors, blood gas analysers used in open-heart surgery, cardioscopes and apnea monitors including those in home care. |
| 4.3(3)(b)A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology—Class IIb. | Examples: diagnostic x-ray sources, linear accelerators. |
| 4.3(3)(c) A device to control, monitor or directly influence the performance of a device in the previous entry—Class IIb. | Examples: auto exposure control systems, radiotherapy afterloading controls systems. |
Rule 4.4 Active medical devices intended to administer or remove medicines, etc. from a patient’s body
This rule covers drug delivery systems and anaesthesia equipment.| Rule 4.4 | Description |
| 4.4(1)An active device to administer or remove medicine, body liquids or other substances—Class IIa. | Examples: suction equipment, feeding pumps, jet injectors for vaccination. |
| 4.4(2)An active device to administer or remove medicine, body liquids or other substances in a way that is potentially hazardous to the patient, having regard to the substances, the part of the body concerned, and the characteristics of the device—Class IIb. | Examples: infusion pumps, ventilators, anaesthesia machines, anaesthetic vaporisers, dialysis equipment, blood pumps for heart-lung machines, hyperbaric chambers, pressure regulators for medical gases, medical gas mixers, moisture exchangers in breathing circuits, nebulisers where the failure to deliver the appropriate dosage form could be hazardous. |
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- FDA cGMP’s. EU MDR’s / MDD’s.
- 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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- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
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- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
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- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
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