Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014.
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