Australia Medical Device Regulations

Regulatory Agency

The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in Australia.

Medical Device Definition

Medical Device:

(a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:

(i) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;

(iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;

(iv) control or support of conception;

(v) in vitro examination of a specimen derived from the human body for a specific medical purpose;

And that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

(aa) any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or

(ab) any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or

(b) an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or (ab); or

Medical devices with a measuring function: For the Regulations (Therapeutic Goods (Medical Devices) Regulations 2002, a medical device has a measuring function if the device is intended by the manufacturer to measure:

(a) quantitatively a physiological or anatomical parameter; or

(b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.

Accessory: in relation to a medical device, means a thing that the manufacturer of the thing specifically intended to be used together with the device to enable or assist the device to be used as the manufacturer of the device intended.

System or procedure packs: Two or more goods (including at least one medical device) are a system or procedure pack if:
(a) all of the goods are to be interconnected or combined for use in a medical or surgical procedure; or
(b) all of the goods are packaged together for use in a medical or surgical procedure.

Active Medical Device:
(a) means a medical device that is intended by the manufacturer:
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
to act by converting this energy; but
(b) 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.

Active Medical Device for Diagnosis: 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, illnesses or congenital deformities.

Active Medical Device for Therapy: 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 handicap.

Medical Device Classification System

International Classification	Risk Level	Examples
Class I	Low risk	Surgical retractors Tongue depressors
Class I - supplied sterile	Low to Medium	Sterile surgical gloves
Class I - with a measuring function		Medicine cup with specific units of measurement
Class IIa		Dental drills; ultrasound machines; digital or infrared thermometers
Class IIb	Medium to High	Surgical lasers Diagnostic X-ray
Class III	High	Prosthetic heart valves Absorbable surgical sutures Hip prostheses (for example, replacement of hip joint) Pacemakers

Regulatory Approval Process

Classification	Approval procedure
Class I	A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods (ARTG). For very low risk devices, a sponsor can self-certify that their product meets the Essential Principles A Manufacturer Evidence application is not required for Class I non-sterile, non-measuring medical devices. for Class I non-sterile, non-measuring devices, you must submit the manufacturer's Declaration of Conformity with your application for inclusion in the ARTG.
Class IIa, IIb, III	Require a formal application for inclusion in the ARTG (Australian Register for therapeutic goods) an independent body must thoroughly assess the device and provide documents to show that the device meets the Essential Principles. If the device is a high risk device (Class III or an Active Implantable Medical Device) the application must be selected for audit. The TGA will review the application and assess the device for safety, efficacy, and quality. Pay the applicable fee.

Notes: Conformity assessment can be conducted by the TGA or by a recognized overseas regulatory body, including notified bodies in Europe and the United States' Food and Drug Administration (FDA).Now sponsors can provide conformity assessment documents issued
by notified bodies designated by a member state of the European Union to support an application for inclusion in the ARTG.
Overseas evidence that can be considered:
1. Certificates issued by Notified Bodies designated by the medical device regulators of European union member states.
2. Decisions of the United States Food and Drug Administration (FDA)
3. Approvals and licenses issued by Health Canada
4. Pre-market approvals from Japan
5. Registrations of the Singapore Health Sciences Authority (HSA)
6. Certificates and reports issued under the Medical Device Single Audit Program (MDSAP)
7. ISO 13485 certificates
The TGA started accepting US FDA 510k approvals to support applications for some implantable medical devices, and these applications are subjected to further scrutiny by TGA to ensure that devices that use this pathway are meeting the requirements.

Additional Information

Approval timeline	Class I: 2 months, Class IIa & IIb: 1 to 2 months, Class III: 2 to 3 Months. The approval process can be delayed if additional information, audit or testing is required.
License validity period	Once the device is included in the ARTG database, the sponsor must make annual payments for the renewal of the registration. Payment must be made at the end of each fiscal year.
Fees	Class I (Sterile) : $602, Class I (Measuring function): $602, Class I (Other): $602, Class IIa: $1150, Class IIb: $1150,Class III: $1483.

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