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Request for expressions of Interest to participate in the IMDRF TOC pilot plan

The International Medical Device Regulators Forum (IMDRF) has recently published the IMDRF Table of Contents (ToC) Pilot Plan.

The ToC Pilot Implementation seeks to work across regulatory jurisdictions to receive premarket submissions from the medical device regulated industry using the IMDRF ToC and Regional Classification Matrices.  Samples are to be real electronic regulatory submissions that will result in regulatory decisions and may be submitted sequentially or simultaneously to multiple participating IMDRF jurisdictions. The Pilot is planned to commence in September 2015.

Currently the participating regulating authorities are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), China, the European Union (Notified Bodies) and the United States (USFDA).

The scope of regulatory submissions accepted during the pilot should be:

  • real regulatory submissions
  • intended for more than one participating jurisdiction over the pilot period
  • accepted regionally for regulatory review

Upon acceptance into the pilot, an information package will be provided containing the most up to date guidance on the ToC pilot. Teleconferences may be offered to help address questions prior to and/or during submission creation.

Expressions of interest or any questions related to this matter should be directed to the IMDRF TOC working group by email to imdrftoc@gmail.com.

This call for expressions of interest has now closed.

Working Group Chair: Ms Nancy Shadeed