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TGA-led IMDRF Personalised Medical Devices working group meets in Canberra

28 October 2019

The International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices (PMD) Working Group met in Canberra from 8 to 11 October to progress their guidance document on the regulation of personalised medical devices. The working group includes members representing all 10 IMDRF member jurisdictions who are contributing to developing an internationally harmonised approach for regulating medical devices that are personalised for an individual. These kinds of devices are becoming more common as technologies such as 3D printing are combined with digital patient images from CT or MRI scans. Existing regulatory frameworks for medical devices don't necessarily address the challenges for ensuring safety and performance of these kinds of devices.

Dr Elizabeth McGrath of the TGA Medical Devices and Product Quality Division chairs the PMD Working Group, which was formed in 2017 and published definitions for different categories of personalised medical devices in 2018. As with all IMDRF working groups, most activities are conducted through international teleconferences that allow all members to participate (usually late at night for Australia!).

The PMD Working Group met face-to-face to discuss the public consultation submissions received on their draft document, and to incorporate the public feedback into a final document. This version will be submitted to the IMDRF Management Committee for formal approval and publishing in 2020.

The proposed regulatory reforms for personalised medical devices being progressed in Australia are aligned with the work of the IMDRF PMD Working Group.

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Seated: Márcia Cristina de Moraes Reis Ribeiro, National Health Surveillance Agency, Brazil; Elizabeth McGrath, Chair, TGA; Heejung Kim, Ministry of Food and Drug Safety, Korea.

Standing: Priscilla Consigliero de Rezende Martins, National Health Surveillance Agency, Brazil; David Wotton, TGA; Andrea Katynski, Health Canada; Shuling Peng, Health Sciences Authority, Singapore; Sunny Woo, Ministry of Food and Drug Safety, Korea; Yoshifumi Nagai, Pharmaceuticals and Medical Devices Agency, Japan.

Via Teleconference: Matthew Di Prima, Food and Drug Administration, USA.