Medtech Guidance Tracker: December 2016
Executive Summary
Stay up-to-date on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. In the latest update, see documents posted in December 2016.
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FDA Provides Accessories Guidance, But May Be 'Missed' Opportunity
While the US agency's final guidance on medical device accessories provides sponsors assurance the agency could be more lenient in classifying their products, an industry group leader says the guidance left a lot of unanswered questions that will continue to create uncertainty for companies.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.