Monday, November 12, 2012

Regulators, Industry Discuss Potential Impact of IMDRF

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body.

Regulators, Industry Discuss Potential Impact of IMDRF > RAPS > News - Article View:

"Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor

This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement."

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