Australia

12/19/2022

Reclassification of active implantable medical devices (AIMD) This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

12/19/2022

Reclassification of active medical devices for therapy with a diagnostic function This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function in meeting their obligations and outlines transitional arrangements to help comply with new regulations.

12/19/2022

Reclassification of medical devices that administer medicines or biologicals by inhalation This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

02/28/2023

Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin This guidance aims to assist sponsors of medical devices that are substances for introduction into the body, meeting their obligations, and outlining transitional arrangements to help comply with new regulations.

03/29/2023

Changes to medical device essential principles for nanomaterials In the recently updated Essential Principle Checklist, Essential Principle 7 now explicitly requires particular attention to the chemical and physical properties and biocompatibility of materials used in medical devices concerning nanomaterials.

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