The TGA has developed an Online Assessment Tool and Online Notification Form for sponsors and agents of non-IVD medical devices included in the ARTG with a need to transition to the new EU MDR to allow continued supply of medical devices in Australia. The use of the Online Assessment Tool and Online Notification Form is optional and not a regulatory requirement.
Please refer to the EU MDR Transition – Online assessment tool and notification form user guide for further information to assist you determine what actions you may need to take because of transition to EU MDR Conformity Assessment documents.
Submission of large files
For sponsors seeking to submit large files in relation to their applications, GovTEAMS has been identified as an appropriate temporary solution to submit large dossiers to the TGA electronically. Please send an email to esubmissions@health.gov.au to request access.
Note that sponsors can have multiple users on the GovTEAMS platform. As their access is setup individually per user, they will need to email esubmissions@health.gov.au for access to their already setup company folder.