Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
TGA
Register your medical device in Australia.
List your device in the ARTG through an Australian Sponsor. Conformity evidence, including MDSAP reports and certificates, is assessed by the TGA according to the device and applicable regulatory pathway.
Speak to a specialistThe authority
Therapeutic Goods Administration
TGA
Regulatory authority
Australia
A division of the Department of Health and Aged Care responsible for regulating medicines, medical devices and therapeutic products in Australia.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, declared conformity | Bandages, gauze, basic instruments |
| Class IIa | Low-to-moderate risk | Contact lenses, diagnostic equipment |
| Class IIb | Moderate-to-high risk | Infusion pumps, surgical equipment |
| Class III | High risk | Non-active implants, advanced surgical equipment |
| AIMD | Active Implantable Medical Devices | Pacemakers, implantable defibrillators |
Registration process
How we manage your project
- 01
Australian Sponsor1-2 months
Appoint an Australian sponsor with a local address (mandatory)
- 02
Classification2 weeks
Determine the class under the TG Regulations
- 03
QMS4-8 months
Implement the applicable QMS; MDSAP reports and certificates may form part of the evidence assessed by the TGA, according to the audit scope
- 04
Conformity Assessment2-4 months
TGA conformity assessment or acceptance of a European NB
- 05
ARTG inclusion4 weeks to 6 months
Submit for inclusion in the Australian Register of Therapeutic Goods
- 06
Release for sale1 week
Active ARTG number and eligibility for commercialisation
Total timeframeClass I/IIa: 4 weeks. Class IIb: 6 weeks. Class III and AIMD: 6 months
Local representativeAustralian Sponsor
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Mandatory Adverse Event Reporting and annual ARTG fee |
| Renewal | Indefinite ARTG inclusion with an annual fee |
| Required QMS | ISO 13485; MDSAP evidence assessed by the TGA according to the Australian requirements audited |
How HSC helps
An Australian strategy assessing MDSAP evidence and the requirements for ARTG inclusion.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about TGA
Next step
Ready to start your project in Australia?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist