International Medical Device Regulatory Update: News and Views From San Jose

Posted 20 December 2016 By Randolph Fillmore

placeholder+image Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

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Categories: Medical Devices, Submission and registration, Features, US, Asia, Latin America and Caribbean, FDA, PMDA

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

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