International Regulators Forum Adds To Ambitious Policy Agenda
This article was originally published in The Gray Sheet
Meeting March 19-21 in France, the International Medical Device Regulators Forum announced a major new project on standalone device software and the upcoming release of several guidance documents for public comment.
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The program would evaluate whether a new system proposed by the International Medical Device Regulators Forum to harmonize device marketing submissions is compatible with the agency's current submission requirements.
As Chinese companies take market share from multinationals in China in some high-risk implantable device categories, FDA's device representative in Beijing says the agency expects to see made-in-China class III devices enter the U.S. Chinese manufacturers, however, face a number of hurdles before this can become reality.
The International Medical Device Regulators Forum issued four final guidance documents on an upcoming pilot that will allow companies to satisfy inspection requirements for four countries in one inspection, and separate documents on a global unique device identification program and standalone software.