TGA Release New Adverse Event Reporting Mechanism for Medical Devices

An online system for the reporting of problems associated medical devices (adverse event reports) is now available to industry and consumers. The Therapeutic Goods Administration’s (TGA) new reporting system consists of online forms which can be accessed from the links below.

• Report a medical device adverse event (medical device user)
• Report a medical device adverse event (sponsor/manufacturer)

Sponsors and manufacturers should note that once their medical device adverse event report has been submitted, any follow-up or final reports still have to be submitted by email, fax or mail. The TGA is currently developing an online system for the submission of follow-up and final reports and will advise when this enhancement is ready.

Should your organisation need to submit an adverse event report, contact KD&A for guidance and support.

 

In addition to this change, the TGA have implemented the Advisory Committee on the Safety of Medical Devices (ACSMD) which has been is established under Part 6 Division 1DA of the Therapeutic Goods Regulations 1990 (the regulations). The role of this committee is to advise and make recommendations to the Minister for Health and the TGA on the safety, risk assessment, risk management and performance of medical devices supplied in Australia.

The ACSMD replaces the Medical Device Incident Review Committee (MDIRC), which was a subcommittee of the ACSMD.  The Committee will meet quarterly and it is hoped the first meeting will be held in the second half of 2012.