Australia
Australia is a highly regulated market for medical devices, with strong demand for innovative products and a risk-based approval system. The sector is valued at approximately AUD 8.5 billion, with an annual growth rate of 5%.
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Regulatory Framework
The competent authority is the Therapeutic Goods Administration (TGA).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in English. |
| Local Sponsor | Required for foreign manufacturers. |
| Certifications | ISO 13485. CE, FDA, and Free Sale Certificate facilitate the process. |
| Biennial Technical File Update | Mandatory for Class III and AIMD devices. The update must be carried out by the local sponsor and approved by the TGA, which may request audits or additional reviews to ensure compliance with regulatory requirements. |
Challenges and Operational Advice
- Detailed regulations: The system aligns with international standards but includes local specifics.
- Sponsor requirement: Foreign manufacturers must appoint an authorized representative in Australia. The sponsor must be a registered entity in the country, with experience in regulatory procedures and TGA compliance. The sponsor is also responsible for updating the technical file and managing communication with the regulatory authority.
Why Choose ISEMED
- International Expertise
Qualified support for the Australian market. - Complete Management
Assistance with TGA compliance and device registration.
FAQ
- Is a local sponsor required? Yes.
- Documentation language? English.
- License duration? Biennial technical file update for Class III and AIMD devices.