Australia Updates Guidance on Export Certificates for Medical Devices: What EU Manufacturers Need to Know
The Therapeutic Goods Administration (TGA) in Australia has released an updated version (January 2026) of its guidance on how to apply for Certificates of Free Sale and Export Certificates for medical devices, including IVDs and Other Therapeutic Goods (OTGs). While the core regulatory principles remain unchanged, the revised document introduces clarifications that may affect non-Australian manufacturers exporting through Australian sponsors.
Key Highlights for Manufacturers
1. Certificates tied to ARTG inclusion
A Certificate of Free Sale is only available for devices that are listed for supply and export on the Australian Register of Therapeutic Goods (ARTG).
An Export Certificate is issued when a device is registered as Export Only—and therefore not available for supply in Australia.
2. Manufacturers must match ARTG data
The manufacturer details on the certificate are pulled directly from the ARTG. If a sponsor submits a list with products from multiple manufacturers, the manufacturing section will be excluded from the certificate front page.
3. Country of import not automatically included
The importing country is no longer included by default. Manufacturers or sponsors must email the TGA prior to issuance to request that the importing country be added to the certificate.
4. Updated formatting and process requirements
Devices are limited to five per certificate front page. Larger lists must be submitted as a schedule on company letterhead, following a specific format (Microsoft Word, portrait orientation, etc.).
Applications must be submitted by the sponsor or authorised agent only, along with a declaration confirming ARTG accuracy and lawful supply status.
5. Turnaround time and delivery
Processing time remains 10 working days, with options for electronic or hard copy delivery. Applicants requesting both formats will be charged two fees.
Why This Matters for EU Manufacturers
If you're an EU-based manufacturer using Australian sponsors to support market access in the Asia-Pacific region, it's crucial to ensure:
Your devices are correctly listed in the ARTG (with current and consistent details).
Your sponsor is informed of any specific import country requirements.
Any accompanying documentation is fully aligned with TGA formatting rules to avoid delays or rejections.
Access the full guidance below.
