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FDA Registrations

It Is That Time of the Year Again…

FDA Annual Establishment Renewal and Drug Listing Certification

The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of Product Listing if you are acting as an authorized agent for the registered establishment.

(Please note: mdi has been providing this service for many of our clients. For Domestic companies their Off. Corresp. and foreign companies their US Agent and Official Correspondent.)

FDA Registration for Foreign Companies

mdi Consultants, Inc. works closely with all levels of business. Helping small companies and manufacturers, as well as large corporations to achieve U.S. FDA compliance. Certificates of Registration* will be supplied by mdiConsultants, demonstrating your company has met the U.S. FDA registration requirements, and mdiConsultants will provide confirmation of the successful completion of the United States Food and Drug Administration’s registration requirements.**

mdiConsultants, has been working with, and helping companies to successfully register, and comply, with U.S. Food and Drug Administration (FDA) regulations for over 25 years.

U.S. Food & Drug Administration Procedures

mdiConsultants, Inc.,  will guide your company through the FDA’s minefield of paperwork and qualifications to move you quickly and efficiently through all FDA processes in a streamlined, thorough, and  effective manner.

US Agent for medical device & Pharmaceutical Manufacturers


Having a U.S. Agent is a requirement of the FDA, for all companies that do not have a place of business within the United States. If you are a foreign based manufacturer, you will not be able to register your facility, list your products and even submit your FDA marketing authorization applications unless you designate a U.S. Agent.

Identification of and contact information for a U.S. agent is required for all foreign manufacturers when they register and list with FDA.

*Please note Certificates of Registration are not required by the U.S. FDA: the Agency does not issue or recognize Certificates of Registration.

*mdi Consultants, Inc. is not affiliated with the U.S. Food and Drug Administration.

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