FDA Medical Device Registration Renewal

Domestic and foreign medical device establishments who registered with US FDA must renew their FDA registration every year between October 1st and December 31st. the renewal fees for the year 2021 is USD 5546. There is no special small business fees for establishment registration renewal. Manufacturer, Importer, Exporter etc... are required to pay the FDA fees.

Foreign manufacturers whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers are required to identify all foreign manufacturers at the time of registration renewal. The renewal fee is same for all Medical device establishments which require FDA registration. The registration renewal is valid till December 31st of next year.

If you need assistance in FDA establishment registration renewal, please complete Medical Device Registration form. LMG will issue a FDA Registration certificate at free of cost after completing the registration renewal.

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