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International Medical Device Regulators Forum

IMDRF Targets Uniform Standards for Medical Device Auditors

The International Medical Device Regulators Forum (IMDRF) has published new recommended requirements for recognizing device company auditors ahead of an international auditing program pilot launching this year in the US, Canada, Brazil and Australia. Separately, the IMDRF has issued final documents on related topics including auditor training requirements, Unique Device Identification (UDI) and software as a medical device.

IMDRF Proposes Convergence on Stand-Alone Software Regulation

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force (GHTF), is seeking comment through August 2013 on proposed definitions of standalone medical device software. The IMDRF sees these definitions as a first step toward establishing an international framework for more uniform regulatory approaches to medical software.

Hospitalar 2013: ANVISA Plans Trial Period for 3rd Party B-GMP Audits

During the annual Hospitalar medical device and technology conference in Sao Paolo, Emergo Group learned that Brazilian medical device market regulator ANVISA plans to launch a two-year trial period to allow third-party audits of Brazilian Good Manufacturing Practice (B-GMP) quality systems.

ANVISA has set a tentative start date of January 2014 for the trial; the US, Canada, Brazil and Australia are expected to participate, meaning that third-party certifiers would be able to audit a manufacturer’s quality system for US, Canadian, Brazilian and Australian requirements at the same time.