Applying for Export Certificates for Medical Devices – TGA Process

Purpose of Export Certificates

Export certificates help manufacturers and sponsors meet regulatory requirements in importing countries by certifying:

• The device is included in the Australian Register of Therapeutic Goods (ARTG) and lawfully supplied in Australia, or
• The device complies with Australian regulatory requirements equivalent to those of the importing country (for devices not supplied in Australia).

Common types include:

• Certificate of Free Sale (CFS) – confirms free sale in Australia.
• Certificate to Foreign Government (CFG) – attests to compliance with Australian requirements.
• Other formats requested by specific countries.

Eligibility Requirements

• The device must be either:
  • Included in the ARTG (with current inclusion), or
  • Manufactured under full quality assurance system (ISO 13485 or equivalent) and meet Australian conformity assessment procedures (even if not yet in ARTG).
• Sponsor/applicant must be the Australian sponsor or authorised representative.
• Device must comply with all relevant Australian Essential Principles and standards.

Application Process

• Submit application via TGA Business Services portal.
• Provide:
  • ARTG entry number (if applicable).
  • Device details (name, classification, GMDN code).
  • Conformity assessment evidence (e.g., Declaration of Conformity, certificate from conformity assessment body).
  • Request for specific certificate format/type.
  • Importer/country details if required.
• Pay applicable fee (varies by certificate type and urgency).
• TGA assesses application for completeness and accuracy.

Processing and Issuance

• Standard processing: typically 20 working days.
• Priority/expedited service available for additional fee.
• TGA issues electronic certificate (PDF) with electronic signature.
• Certificate validity usually 2 years or linked to ARTG inclusion expiry.

Important Notes

• Certificates confirm status at issuance date; changes to ARTG entry may require new certificate.
• TGA does not guarantee acceptance by foreign authorities.
• Sponsors must maintain compliance; TGA may revoke or refuse issuance if non-compliance found.
• For devices not in ARTG, additional documentation (e.g., QMS certificate) required.

Detailed eligibility criteria, certificate types, required documents, application checklists, fee schedule, processing timelines, and country-specific notes are provided in the TGA guidance on applying for export certification for medical devices. Source: Applying for export certification for medical devices - TGA

This process facilitates international trade of Australian-regulated medical devices while maintaining regulatory integrity.