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
Australia offers two primary regulatory pathways for medical device and IVD approval under the TGA Medical Device Regulations: the Abridged Route and the TGA Conformity Assessment Route. Each path is designed to accommodate different prior approvals and device readiness levels.
Abridged Route
The Abridged Route is a faster assessment process for devices already recognized overseas regulatory approvals. This pathway reduces review timelines, making it an efficient option for manufacturers with prior certifications.
Eligible approvals for the abridged route include:
- CE Mark
- FDA Approval
- Certification under the Medical Device Single Audit Program (MDSAP)
- Approvals from Singapore, Malaysia, or India
Manufacturers can streamline their journey to TGA approval and market access by leveraging these existing certifications.
TGA Conformity Assessment Route
If the abridged route is not an option, manufacturers must follow the TGA Conformity Assessment Route. This involves a comprehensive and systematic review by the Therapeutic Goods Administration (TGA). Key elements of the conformity assessment include:
- Examination of technical documentation to ensure compliance with the TGA’s essential principles.
- Review of the manufacturer’s quality management system (QMS).
- Verification that the medical device or IVD meets all regulatory requirements for safety and performance ensures that the product adheres to Australia’s rigorous standards, paving the way for market approval.
Why Consider Australia for Medical Device Market Entry?
Australia’s participation in global regulatory frameworks, such as MDSAP, and its recognition of approvals from other jurisdictions make it an attractive market for manufacturers. With existing certifications, entry can be faster and more efficient, allowing you to capitalize on opportunities in this growing healthcare market.
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