IMDRF Says Device Identification, Electronic Product Submission Documents Coming Soon

Posted 05 April 2013 | By Alexander Gaffney, RAC 

The most recent meeting of the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), indicates that the organization is quickly progressing on several notable projects, including a unique device identification (UDI) proposal, an auditing competency standard, and the regulated products submission (RPS) standard.


IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own group without the involvement of industry.

At present, organizations involved in the IMDRF include the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP). At IMDRF's 19-21 March 2013 meeting, it was also announced that China had become a full member, and that Mexico had been invited to participate as an official observer, potentially clearing the way to later join the organization.

Since its launch, IMDRF has been moving forward in a number of product areas, most notably including the UDI and RPS proposals.

UDI Proposal

A UDI is a labeling or marking standard by which regulators can keep track of a product-a sort of track-and-trace method for medical devices that allows anyone to determine from where a product originated and other information about a device.

Several countries and regions, including the US and the EU, have been looking to implement a UDI proposal. In a separate statement to Regulatory Focus, FDA's Jay Crowley, senior adviser for patient safety at CDRH, noted that all countries involved in the UDI process are "well aligned."

"We continue to work in the IMDRF working group on UDI--which includes good representation from US, EC China, Japan and others," Crowley added.

In its update, IMDRF said its "work on the revised Unique Device Identification Draft Guidance 2.0 on labeling specifications is progressing," and that it anticipates having a document available for public consultation at some time in the "near future." 

RPS Proposal

IMDRF has also been working on the RPS standard, which it envisions as a sort of electronic common technical document for medical devices (including IVDs at a later time) that could then be used to make a single submission that is recognizable by multiple regulatory authorities.

IMDRF's update explains that its draft work item on RPS was accepted and endorsed by the IMDRF Management Committee, and that the draft table of contents will be "submitted for public consultation in the near future" as well.

The RPS system has been one that some regulators believe could have an outsized impact on the global regulatory system. In a speech in March 2013, FDA's  Kim Trautman explained that the IMDRF group is trying to "marry" a similar RPS effort under development by the International Conference on Harmonization (ICH)-a pharmaceutical-focused harmonization group. "Clearly, if we're going to be working on electronic submissions to any one of our particular agencies, we are looking to have a coordinated effort between our different sister commodities such as drugs, devices, biologics and so forth," Trautman said.

This could, in theory, make it much easier for a combination drug-device product to be submitted to multiple agencies around the world.

Tratuman said she anticipated a pilot program will be launched during the summer of 2013.

Other Updates

The IMDRF update also provided news about a number of other proposals and developments.

  • IMDRF is reviewing GHTF's N79 Guidance, and is preparing a proposed work program to revise and finalize the guidance by the end of 2013.
  • Documents regarding the medical device audit training and competency system will be submitted for public consideration soon, with comments due by 15 June 2013.
  • Discussions on a list of recognized standards continue, and should be completed by the end of summer 2013.

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