Therapeutic Goods Administration (TGA) Introduce Online Medical Device Incident Reporting (MDIR) System

The TGA have introduced a new online MDIR System for sponsors and manufacturers which is accessible via their eBusiness system (also used to submit applications). The eBusiness system can only be accessed by companies who have completed a TGA Client Details Form to establish themselves with the TGA (and have the necessary eBusiness username and password).

The System is designed to improve ongoing reporting and monitoring for adverse events which have been reported to the TGA using the online adverse event incident reporting form (acessible here or from an eBusiness account). The new system allows medical device manufacturers and sponsor to lodge reports, update reports and provide additional information. All information is immediately received by the TGA when added to the system and can be validated prior to submission.

For further information regarding the system, refer to the TGA MDIR User Guide. Contact KD&A for assistance in establishing a Post Market Surveillance System which meets both your organisation’s requirements and the TGA’s regulatory requirements.