FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Notified Body Advises Embracing Global Standards as Brexit Looms

Aug. 17, 2017
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Ireland’s national standards organization and notified body is advising devicemakers to become certified to global standards to get ahead of uncertainty surrounding Brexit.

The National Standards Authority of Ireland predicts the device sector will expand further with the introduction of the Medical Device Single Audit Program as the standardized, global approach to auditing and certification for medical device manufacturing.

Regulatory authorities in Australia, Brazil, Canada, Japan and the United States are concluding a three-year MDSAP pilot before the formal program gets underway. Health Canada has said it will only accept MDSAP certificates, starting Jan. 1, 2019.

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