Australia Medical Device Regulations

The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in Australia
Medical Device Definition
A medical device is defined in the legislation as any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related devices (including any diagnostic product for in vitro use) that is intended by the manufacturer to be used, alone or in combination, for human beings for the specific purpose of one or more of the following:
  • diagnosis, prevention, monitoring, treatment, or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;
  • the investigation, replacement, modification, or support of the anatomy or a physiological process;
  • supporting or sustaining life;
  • control of conception;
  • disinfection of medical devices;
  • providing information for medical purposes using in vitro examination of specimens derived from the human body;
  • and does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.
Classification of Medical Device
International Classification Examples Risk Level
Class I Surgical retractors
Tongue depressors
Low risk
Class I - supplied sterile Sterile surgical gloves Low to Medium
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 Surgical lasers
Diagnostic X-ray
Medium to High 
Class III Prosthetic heart valves Absorbable surgical sutures Hip prostheses (for example, replacement of hip joint) Pacemakers High
Premarket Approval Process *
Classification Approval procedure
Class I
  • Notified the TGA of inclusion in the ARTG (Australian Register for therapeutic goods)
  • The device required an application for registration with an applicable fee.
Class IIa
  • Require a formal application for inclusion in the ARTG (Australian Register for therapeutic goods)
  • The TGA will review the application and assess the device for safety, efficacy, and quality. Pay the applicable fee.
Class IIb
Class III
Notes: - Device manufacturers must demonstrate conformity with the relevant standards and regulatory requirements by submitting a Technical File or a Quality Management System (QMS) certification. Once the TGA is satisfied that the device meets the required standards, it will be included in the ARTG
Additional Information
Approval timeline Class I:- 1 month, Class IIa & IIb:- 3 to 6 months, Class III:- Up to 12 months. The approval process can be delayed if additional information or testing is required.
License validity period 5 years
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