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TGA pilot of IMDRF Table of Contents for medical device submissions
IMDRF IVD and nIVD Table of Contents
The International Medical Device Regulators Forum (IMDRF) is a forum to discuss future directions in medical device regulatory harmonisation. The IMDRF Regulated Product Submission Working Group is addressing harmonisation of medical device submissions to regulatory bodies.
To harmonise submissions of premarket applications, the IMDRF has developed an electronic file structure for In-Vitro Diagnostic (IVD) and a non-IVD (nIVD) devices, known as the Table of Contents. The intention of the ToC is to provide an internationally agreed file structure for the content of medical device premarket regulatory submissions.
Currently the participating regulatory authorities are Australia (Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), China (China Food and Drug Administration), the European Union (Notified Bodies) and the United States of America (US FDA).
The ToC file structure for medical device regulatory submissions will be trialled in a pilot program.
TGA participation in the pilot of IMDRF Table of Contents (ToC) submissions
The TGA has participated in the development of the IMDRF IVD and n-IVD ToCs and is participating in the pilot program to trial the ToCs for conformity assessment pre-market applications.
This web page has links to the required information for the development of pilot submissions. It is anticipated that if the trial is successful future medical device regulatory submissions will be based on the proposed internationally standardised structure.
The IMDRF IVD and nIVD Table of Contents is comprehensive to cover requirements for all participating regulatory jurisdictions (regions). Not all regions will require content under each heading of the ToC. Each region has developed Classification Matrices to guide Applicants as to the required content for submissions in the particular region.
Participation in the pilot is voluntary. If applicants wish to participate with an application for the same device to more than one region, they should contact the IMDRF working group via firstname.lastname@example.org. The TGA is also willing to consider applications made to the Australian regulator only, including applications for devices incorporating medicines. Although these would not form part of the official IMDRF Pilot, they would be considered as part of a 'Regional Pilot'. Feedback on the proposed ToC is invited in either case. If accepted for a pilot submission to Australia, applicants should comply with the following:
- IMDRF Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (pdf,128kb)
- IMDRF Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (Microsoft Word,88kb)
- TGA Regional Assembly and Technical Guide
- TGA general dossier requirements
- Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC)
- IMDRF nIVD folder structure (zip,47kb)
- TGA IMDRF nIVD ToC classification matrices (Microsoft Excel,33kb)
- In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
- IMDRF IVD folder structure (zip,45kb)
- TGA IMDRF IVD ToC classification matrices (Microsoft Excel,32kb)
|Region||Email contacts||Regional documents|
|Australia||Australia ToC Pilot Contact||(provided above)|
|Brazil||Brazil ToC Pilot Contact||Brazil (Portuguese)|
|Canada||Canada ToC Pilot Contact||Email Request to Contact|
|China||Email Request to Contact|
|EU||EU ToC Pilot Contact||European Union|
|USA||USA ToC Pilot Contact||United States|