{"id":26129,"date":"2023-01-05T17:06:25","date_gmt":"2023-01-05T16:06:25","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=26129"},"modified":"2023-10-06T10:23:06","modified_gmt":"2023-10-06T08:23:06","slug":"medical-device-registration-in-the-u-s-a","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-the-u-s-a\/","title":{"rendered":"Medical device registration in the U.S.A."},"content":{"rendered":"
\"usa\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Food and Drug Administration (US FDA)<\/p>\n

Classification<\/strong><\/h5>\n

I, II, III<\/p>\n

Quality system<\/b><\/h5>\n

A Quality System compliant with 21 CFR P art 820 et alter is required. Considering that, compared to previous versions of the same standard, the requirements of the latest version of ISO 13485:2016:2016 are closer to the Quality System Regulations (QSR)<\/strong><\/a>, FDA has expressed its intention to harmonize the QSR with international requirements, thus transitioning from QSR \u2013 21 CFR 820 to ISO 13485:2016:2016. The United States participate in the MDSAP<\/strong><\/a> Program (Medical Device Single Audit Program) together with Brazil, Canada, Australia and Japan.<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of July 2020. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

In order to be marketed in the United States, all Medical Devices must be registered with the FDA. Manufacturing facilities are subjected to FDA inspections to ensure compliance with the American GMP requirements. In addition, each establishment where production, distribution, import and marketing of Medical Devices are performed in the U.S.A. must be disclosed and registered at the FDA, through Establishment Registration, in accordance with 21 CFR 807.<\/p>\n

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