Consultation on sharing more information about medical devices

While the consultation is open you can make a submission at our TGA consultation hub. 

After the closing date, the submissions will be reviewed, and outcomes will be made available on the same page at the TGA consultation hub.

About this consultation

The proposed changes intend to provide more information to the public after post-market reviews or investigations of medical devices, particularly where review findings relate to the safety, quality, performance or use of a medical device. 

These changes align with the intent of An Action Plan for Medical Devices, which aims to provide more information to patients about the medical devices they use. It also aligns with requirements set out in the World Health Organisation’s (WHO) Global Benchmarking Framework. 

Section 61 of the Therapeutic Goods Act 1989 (the Act) facilitates the release of information in certain limited circumstances. This consultation seeks feedback on proposals to expand our ability to release information lawfully. Feedback is sought on:

• if we should share information about medical devices included in a post-market review or investigation, and 
• what types of information should be shared when a post-market review or investigation is being undertaken. 

The consultation takes approximately 10 minutes to read and complete. Noting that if you read the paper in depth and/or provide detailed written responses it may take longer.

Related consultations

The TGA has previously consulted separately on releasing information to support management of disruptions to supply of medical devices. Outcomes have been published on the TGA consultation hub.

All recent TGA consultations can be found at the TGA consultation hub - external site.