Representation for foreign manufacturers
Australian Sponsor requirement
A foreign manufacturer must appoint a sponsor if they want to supply devices in Australia. The sponsor must be a resident of Australia or be an incorporated body conducting business in Australia. This could be your distributor, but appointing an independent third party gets more control of registration and provides more flexibility in changing distributors or appointing multiple distributors for better market penetration.
Your sponsor should:
- Apply to the TGA to have therapeutic goods included in the ARTG
- Notify the TGA of any incidents and performance issues
- Assist the TGA and the manufacturer with investigations
- Maintain distribution records for products supplied to Australia
- Include their name and address on the labels and IFU
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Additional Regulatory Requirements
Required Registration Documentation
The required documentation depends on the registration route and risk class. Overall, you need to consider the following documents:
- Labels, instructions for use (IFU), packaging
- Patient information leaflet
- Cards for implantable medical devices, if applicable
- Device classification assessment
- Risk management reports
- Clinical evidence plan and reports
- Validation and Verification Test Reports
- QMS certification (e.g., MDSAP certificate or TGA Certificate)
- Australian Declaration of Conformity (different templates for every risk class)
- Australian Essential Principles Checklist
- Australia-specific post-market surveillance requirements
Regulatory Routes for Australia
Abridged route
Australia has recognized certain overseas regulatory approvals, allowing for a faster device assessment process and decreasing overall review timelines. Products covered under the scope of a CE mark, FDA approval, and certified under MDSAP follow a faster assessment pathway than those without. Approvals from Singapore (expedited and abridged route), Malaysia, and India can also be lodged for TGA approval.
TGA Conformity Assessment route
Is an abridged route not possible for you? You will have to undergo a full TGA review. This is a systematic and ongoing examination of evidence and procedures to ensure that the medical device, or IVD, complies with the TGA's essential principle. The TGA will review your technical documentation and quality management system to obtain approval.
Australia TGA Medical Device Regulations make this country an interesting market to enter if regulatory approvals are owned in other jurisdictions.
Registration Validity
Medical Device Approval Australia
For submissions with Class Is, Im IIa, and IIb that rely on MDSAP, CE, or US FDA, the registration will remain valid if the supporting certifications are still active and within the expiry date of the respective certification.
For the TGA conformity assessment certificate, a validity of five years applies.
Regulatory timelines and fees
How long does it take to enter
the Australian medical device market?
The review times depend on the risk class and the completeness of the documentation that is provided to the TGA, and if your device is subject to auditing but the overall timelines are as follows:
- Class I: 24 hours to 4 weeks
- Class Is, Im, IIa, and IIb: 2-4 months
- Class III and AIMD: 6-8 months
- Full TGA Conformity Assessment: 18-24 months