M2M HL7 SPL Testing Completion Confirmation Form
The TGA requires medical device sponsors, manufacturers, or agents to complete and submit a confirmation form demonstrating that their organisation has completed M2M HL7 SPL testing in accordance with the validation procedure outlined in the M2M HL7 SPL User Guide for AusUDID compliance.
Manufacturers and sponsors placing medical devices on the Australia market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗