International News In Brief

A special forum for medical device regulatory stakeholders at the March 19-21 meeting of the International Medical Device Regulators Forum attracted 130 participants from 23 countries, including industry representatives, medical professionals, patients, and academics, according to a post-meeting outcome statement from IMDRF. Since IMDRF replaced the Global Harmonization Task Force, device makers have been trying to be heard by the regulators-only organization. (See Also see "With Transition To IMDRF, Focus Shifts To Convergence On Discrete Regulatory Practices" - Medtech Insight, 26 November, 2012..) The stakeholder forum, held on the second day of IMDRF's March 19-21 meeting in France, included updates on regulations in Australia, Brazil, Canada, China, the EU, Japan, and the U.S. In addition, participants heard progress reports on IMDRF's top work items and shared their views on the work.

The IMDRF management committee approved two new work items: the international harmonization of regulations for stand-alone medical device software, and the definition of common data elements describing medical devices through...