Posted 14 August 2014
By Alexander Gaffney, RAC
The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada.
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 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, unique device identification standards, and a regulated products submission (RPS) table of contents (ToC).
Regulated Product Submissions
The RPS is intended to be a sort of Common Technical Document—created by the International Conference on Harmonisation (ICH), a drug harmonization body, to facilitate the submission of new drugs across multiple regulatory regions—for medical devices.
The effort should, in theory, make it much easier to submit medical device applications to multiple regulatory authorities without needing to fill out region-specific application forms.
In April 2013, IMDRF released the draft version of two RPS ToC files intended to facilitate the submission of IVD and non-IVD products.
The agency has now finalized those two documents: In Vitro Diagnostic Medical Device Market Authorization Table of Contentsand Non-In Vitro Diagnostic Device Market Authorization Table of Contents.
The highly technical documents outline what each participating regulator expects in an application while providing a standard "heading" format for their submission.
For the US medical device industry, it's perhaps worth noting that both documents bear the signature of Jeffery Shuren, director of FDA's Center for Devices and Radiological Health (CDRH). Shuren also currently serves as chair of the IMDRF. His signature is a likely sign that the agency plans to implement the new RPS standards, though it remains unclear as to when that might occur.
IMDRF Document Page