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TGA participation in the IMDRF Table of Contents (ToC) pilot
The International Medical Device Regulators Forum (IMDRF) has developed a Table of Contents (ToC) that is intended to provide a comprehensive submission structure that can be used as a harmonized international electronic submission format for medical device premarket evaluation. The intent is to reduce regional divergence for device submission requirements to reduce burden on industry, and also, to provide more uniformity in submissions to increase efficiency of assessment bodies when reviewing submitted data.
The TGA will participate in the IMDRF pilot to trial the ToC submission format, see: Table of Contents (ToC) Pilot Plan. Industry is invited to submit applications for Conformity Assessment using the ToC structure for the supporting data. Combination products (devices incorporating a medicine) are out of scope for the IMDRF pilot; however the TGA will accept such submissions on a regional pilot basis. Further details, including Australia-specific guidance and regional matrices will be published soon on the TGA website.
Expressions of interest for participation in the cross-jurisdictional IMDRF pilot, or any questions related to this matter, should be directed to the IMDRF TOC working group by email to firstname.lastname@example.org.
Questions relating to the TGA participation in the IMDRF pilot should be directed to email@example.com.