TGA
We are seeking feedback on our proposal to improve information sharing about the performance of medical devices.
Background
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 proposed 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.
We are seeking feedback on proposals to expand our ability to release information lawfully under section 61 of the Therapeutic Goods Act 1989. We would like to know 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.
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