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January 16, 2026
Approximately 5 minutes
Application for Certificate of Free Sale or Export Certificate – Medical Devices (TGA)
Application for Certificate of Free Sale or Export Certificate – Medical Devices (TGA)
Overview
The TGA issues certificates to confirm that a medical device is lawfully included in the Australian Register of Therapeutic Goods (ARTG) and may be supplied in Australia (or meets equivalent standards if not supplied locally). These certificates are often required by importing countries for customs clearance or regulatory registration.
Common uses:
- Certificate of Free Sale (CFS): Confirms free availability in Australia.
- Export Certificate: General attestation of compliance or ARTG status.
Who Can Apply
- The Australian sponsor named in the ARTG entry.
- Authorised representative acting on behalf of the sponsor.
- Manufacturer (in limited cases, with sponsor authorisation).
Eligible Devices
- Devices currently included in the ARTG (active inclusion).
- Device must be compliant with all conditions of inclusion.
- Certificates are not issued for devices that are:
- Cancelled or suspended from the ARTG.
- Subject to unresolved safety concerns or recalls.
Required Information and Documents
Applicants must provide:
- ARTG entry number(s).
- Device name, classification, and GMDN code.
- Sponsor details and ABN.
- Destination country and purpose of certificate.
- Specific certificate type requested.
- Supporting documents (if requested):
- Current ARTG extract.
- Declaration of Conformity.
- Evidence of conformity assessment (for higher classes).
Application Steps
- Log in to the TGA Business Services (eBS) portal.
- Navigate to the medical device export certificate application form.
- Complete all mandatory fields and attach supporting documents.
- Pay the applicable fee (standard or priority service).
- Submit the application electronically.
- TGA reviews for completeness and compliance.
- Certificate issued electronically (PDF with electronic signature).
Processing Time and Fees
- Standard processing: Approximately 20 working days.
- Priority/expedited service available for additional fee (faster turnaround).
- Fees are listed in the current TGA fee schedule (non-refundable if application incomplete).
Important Notes
- Certificates reflect status at the time of issuance; subsequent ARTG changes require a new application.
- TGA does not guarantee acceptance by foreign authorities.
- Providing false or misleading information may result in refusal, revocation, or penalties.
- Keep records of issued certificates for traceability and audits.
Detailed instructions, form fields, supporting document requirements, fee details, processing timelines, and frequently asked questions are available in the TGA application form for Certificate of Free Sale or Export Certificate for medical devices. Source: Application for Certificate of Free Sale or Export Certificate – Medical Devices - TGA
This process enables efficient export compliance while maintaining the integrity of Australian regulatory oversight for medical devices.
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