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Regulatory Focus™ > News Articles > New IMDRF Document Explains How an Idea Becomes International Regulatory Guidance

New IMDRF Document Explains How an Idea Becomes International Regulatory Guidance

Posted 17 December 2013 | By Alexander Gaffney, RAC

Nearly one year after the International Medical Device Regulators Forum (IMDRF) replaced the Global Harmonization Task Force (GHTF), the manner in which the new group functions is getting clarity thanks to a finalized standard operating procedures document released this week.


IMDRF launched in 2012 as the regulators-only successor to the GHTF, which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture 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).

The group has been hard at work, endeavoring to pick up where GHTF left off and increase the pace at which regulatory harmonization occurs.

Among the documents the group has released since its launch: standardized definitions of standalone software, training requirements for auditing organizations, standards for auditing organizations, a unique device identification standards, and a regulated products submission (RPS) table of contents.

New Guidance on IMDRF's Processes

But unless you're a regulator, it can be difficult to discern how IMDRF operates. Now a new document released on 17 December 2013 promises to cast some new light on how its documents are generated, its members organized and existing documents maintained.

The final document, IMDRF Standard Operating Procedures, provides a glimpse inside the operation of IMDRF. For example, it notes the standards by which a member of its management committee may be considered, and explains that any one of its existing management committee members can prevent a new member from joining the committee.

The document also explains the process by which "invited observers," including the medical device industry, can be involved in Management Committee meetings to help guide the work of IMDRF. Their participation will be considered on a meeting-by-meeting basis, IMDRF said, and they are not allowed to participate in the decision-making process.

But just as important in the document is the process by which IMDRF's technical documents are produced. Such documents ultimately determine how regional authorities regulate medical devices, and are hugely influential.

IMDRF notes in its document that new work items need to have a clearly articulated scope and timelines for completion. Once a new work item is agreed to, it is assigned by the management committee to a specific IMDRF Working Group for completion within 18-24 months. Once the Working Group is done with the document, it is then circulated to IMDRF stakeholders for comment, though in some cases (Working Groups with closed memberships) drafts will only be circulated to regulatory authorities-not members of industry.

After a consultation period, the document (previously a working draft) then becomes a proposed document and is reviewed again by IMDRF's Management Committee, which can choose to either advance the document or cease its development. This takes place over a four- to six-week period.

Approved proposed documents will then be posted to IMDRF's website and with the intent of allowing members of industry and others to comment on the document. The Working Group will then consider the document, revise it and report the final document to the Management Committee within three months' time.

The Management Committee will then have five weeks in which to review the final document, at which time it can either approve or terminate the document. Once approved, the document will be published to IMDRF's website and begin the implementation process.

Both IMDRF and GHTF documents will be updated on an "as-needed" basis, the document states. Stakeholders who believe a document is out of date should contact IMDRF's Management Committee.

IMDRF Standard Operating Procedures

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