Register With US FDA
Registrar Corp helps companies across all FDA-regulated industries comply with FDA registration regulations quickly and properly.
Registrar Corp can help your facility register with FDA and much more.
FDA Registration and Renewal
FDA-registered food facilities are required to register with FDA and renew their registration every other year on even-numbered years.
DUNS Assistance
All drug establishments and food facilities are now required to submit Unique Facility Identifiers (UFIs) as part of their initial FDA registration as well as their registration renewal. Currently, the only UFI recognized by FDA is the DUNS number.
NEW IN 2022: All registered food facilities must include their DUNS number in their registration renewal for the October-December 2022 renewal period.
U.S. Agent
All registered food facilities located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments and assist in organizing food facility inspections.
Prior Notice
FDA requires the filing of Prior Notice for all food, beverage, and dietary supplements shipments entering the United States. Prior Notice submissions must contain certain pieces of information, including a valid FDA registration number.
Mock FDA Inspection
FDA may choose to conduct a routine inspection of any registered food facility based on a number of factors. Registrar Corp can dispatch a Food Safety Specialist to help your facility prepare for an FDA inspection. We offer these to our existing clients at a reduced rate.
Access to MyFDA
MyFDA is an online portal that helps you manage your food facility registration and compliance data. Access includes:
- Certificate of Registration: Certificates issued by Registrar Corp provide confirmation of your facility’s registration to industry
- Registration Updates: Registrations must be updated within 60 days of a change in required information
- Prior Notice: Three free Prior Notice filings each year for your exports to the USA
- FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status
- Compliance Document Drive: Store and share your required FDA Compliance Documents, such as Food Safety Documentation, GFSI Certifications, Product Labels, and more
FDA Registration and Renewal
Medical device establishments that produce and distribute products for use within the U.S. must register and renew their registration annually.
FDA UDI and GUDID Compliance Solutions
Under the FDA Unique Device Identifier (UDI) rule, most medical device labels and packages must bear a UDI. The device labeler must apply the UDI and submit device information, including a device identifier (DI), product codes, and other characteristics to the Global Unique Device Identification Database (GUDID).
U.S. Agent
All registered medical device establishments located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments.
Master File Submission
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or National Medical Products Association (NMPA) in China. Registrar Corp prepares and submits Medical Device files to 18 regulatory agencies worldwide.
Electronic Medical Device Reporting (eMDR)
Device manufacturers and importers must submit adverse event reports to FDA when evidence suggests a device may have contributed to a patient death or serious injury, or when a device malfunctions and reoccurrence of the malfunction would likely contribute to death or serious injury. Companies must report adverse events in electronic format.
FDA Registration and Renewal
Drug establishments that produce and distribute products for use within the U.S. must register and renew their registration annually. Additionally, drug establishments must submit a list of every drug in commercial distribution in the U.S.
DUNS Assistance
All drug establishments are now required to submit Unique Facility Identifiers (UFIs) as part of their initial FDA registration as well as their registration renewal. Currently, the only UFI recognized by FDA is the DUNS number.
U.S. Agent
All registered drug establishments located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments.
Master File Submission
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or National Medical Products Association (NMPA) in China. Registrar Corp prepares and submits Drug files to 18 regulatory agencies worldwide.
FDA Registration and Renewal
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetics companies must comply with new regulations, including mandatory facility registration, product listing, adherence to GMPs, and much more.
