GMDN

Update on GMDN Governance

7 December 2022

An Authorities Strategic Advisory Group committee has been established to provide advice and feedback to the GMDN Agency and the Board of Trustees. Find out more…

Earlier this year, the Trustees established the Authorities Strategic Advisory Group (ASAG) committee, which represents medical device regulators that use the GMDN.

The ASAG’s key role is to provide advice and feedback to Trustees and the GMDN Agency, including:

• Having appropriate review structures in place to ensure that relevant stakeholders, including from different regions, can provide feedback and be consulted about the GMDN supporting their needs.

• The promotion of the GMDN to encourage broader adoption and global harmonisation of the GMDN as a detailed nomenclature that underpins an efficient and effective regulatory model of safety and performance for medical devices.

• Enhancing medical device safety by use of the GMDN that facilitates and promotes data exchange and analysis.

In 2022 ASAG had three meetings. Participating were representatives of the FDA, TGA and Health Canada, and the Trustees were invited as observers. The meetings provided valuable feedback to the Trustees to better understand the needs of members.

In 2023 ASAG will meet regularly, and as interest in the group grows, we aim to expand the membership.

As a regulated charity, all ASAG members and observers are volunteers and not funded for activity linked with GMDN Agency governance.

If you wish to have more information on ASAG, please contact us at Contact Us – GMDN (gmdnagency.org)