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Regulatory authorities in Australia, Brazil, Canada, Japan and the United States are concluding a three-year MDSAP pilot before the formal program gets underway. Read More
Ireland’s national standards organization and notified body is advising devicemakers to become certified to global standards to get ahead of uncertainty surrounding Brexit. Read More
Brazil’s National Agency for Sanitary Vigilance is seeking industry comments on a proposal that would extend licenses for medical devices from five years to 10 years. Read More
The FDA’s Patient Engagement Advisory Committee (PEAC) will hold its inaugural meeting in Gaithersburg, Maryland, October 11-12 to discuss how patients, devicemakers, and the FDA can share information. Read More
As one of its final items before leaving for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work. Read More