TGA Transitions to Electronic Process for Device Certificates
Sponsors of medical devices now have a new process to apply for a certificate of free sale or an export certificate in Australia, the Therapeutic Goods Administration (TGA) announced Tuesday.“Some sponsors have recently experienced issues when attempting to have certificates of free sale and export certificates notarised and endorsed,” the regulatory authority said. The newly implemented application process allows for sponsors to submit applications and receive these certificates from TGA electronically “in an effort to immediately address these issues.”
These documents are requested by certain countries for a sponsor to certify that its device is freely sold on the Australian market and is approved for export from the country. Applications for a certificate of free sale or an export certificate are subject to a fee of $180 each, as of June.
To apply for either certificate, eligibility is dependent on three main criteria: being the sponsor of the device, a current inclusion in the Australian Register of Therapeutic Goods (ARTG) and an exemption set forth in provisions of the 2002 Therapeutic Goods Regulations.
Sponsors are encouraged to first contact foreign governments as the certificates “aim to meet the needs of the importing country,” the regulatory authority clarified.
TGA intends to complete reviews of these application types within 10 business days. Yet the process “may take longer if there appear to be discrepancies” between an application and ARTG inclusion data for the relevant products oo it the application is voluminous in nature.
Certain other limitations apply, including the rejection of applications for certificates of free sale for products listed as export-only devices in the ARTG. Another potential reason relates to the global system for identifying and classifying devices—the Global Medical Device Nomenclature (GMDN). GMDN codes must be included in applications and match those on ARTG certificates.
GMDN use has been further encouraged in recent years as part of the ongoing push for global regulatory harmonization. This includes several planned changes to the electronic filing system for device submissions to the US Food and Drug Administration, set for launch in the coming months.
In 2015, TGA also launched a pilot for electronic evaluations of premarket submissions using the International Medical Device Regulators Forum’s (IMDRF) Table of Contents (ToC). Health Canada, meanwhile, announced a transition to IMDRF’s ToC and the GMDN earlier this year.
TGA