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Australia Medical Device Regulations

Agency
The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in Australia.
Medical Device Definition
A medical device in Australia means the following:
(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
(c)  a system or procedure pack.
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
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
  • 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.
Class IIb
Class III
Notes:- Conformity assessment can be conducted by the TGA or by a recognised overseas regulatory body, including notified bodies in Europe and the United States' Food and Drug Administration (FDA).
The TGA has only recently 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 or testing is required.
License validity period 5 years
Fees Class I (Sterile) : $1098, Class I (Measuring function) : $1098, Class I (Other) : $575,
Class IIa : $1098, Class IIb : $1098,
Class III : $1416.
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