Answers to some of our most frequent questions
US AGENT SERVICES
Do I need a US Agent?
US Agent appointment is mandatory for all foreign companies who wish to market their drug, food or medical device products in the United States. In the vast majority of cases, the FDA communicates with companies through the US Agent.
Change of U.S. agent - what is the impact?
Change of U.S Agent will not affect your registration or business. You can change the U.S Agent name in the FDA registration anytime.
Why is it necessary to hire a US FDA Agent for FDA registration?
Hiring a US FDA Agent is mandatory for foreign establishments that want to register their facilities and products with the FDA. The agent serves as a point of contact between the FDA and the foreign company.
How do I find a reliable and experienced US FDA Agent?
You have found a reliable and experienced US FDA Agent with FDA Agent Pro. To find a reliable US FDA Agent, you can search online directories, consult industry associations, or seek recommendations from other companies in your industry. It's important to verify their credentials and experience in FDA regulatory matters.
What are the benefits of hiring a US FDA Agent for FDA compliance?
Hiring a US FDA Agent brings several benefits, including expert knowledge of FDA regulations, assistance with documentation and submissions, representation during FDA inspections, and overall guidance to ensure compliance with FDA requirements.
How much does it cost to hire a US FDA Agent?
Our standard US Agent fee is $299 for one year. We offer discounts for multiple years of U.S. Agent services. All U.S. Agent services are included in our FDA facility and establishment registrations.
What is the role of an official correspondent?
An Official Correspondent manages FDA communications, annual registrations, and updates. Registrar Corp handles these responsibilities, ensuring devices meet compliance standards year-round.
Why do non-U.S. Medical Device establishments need a U.S. Agent?
The FDA requires Non-U.S. Medical Device Establishments to appoint a U.S. Agent as a communication link for inspection notices and updates. FDA Agent Pro provides 24/7 support as your professional U.S. Agent.
Do All foreign food facilities require US FDA Agent for registration?
Yes, All foreign facilities should have an agent at the time of registration. The FDA Agent act as a communication link between U.S FDA and the Facility.
FDA REGISTRATION SERVICES
How long does it take to register my company?
Most food facility and OTC drug establishment registrations are complete within 1-2 days, cosmetic and medical device facility registration within 3-5 days. A common reason for the delay is when the DUNS address does not match the provided facility address.
What is FDA Drug Establishment Registration?
Drug establishment registration is required for U.S. and non-U.S. companies that manufacture or process drugs intended for U.S. commerce. It ensures these companies comply with FDA regulations by annually registering their establishments and listing their products.
When do I need to renew my FDA registration?
Drug establishments must renew their registrations annually between October 1st and December 31st.
What is FDA Medical Device Registration?
FDA Medical Device Registration is a mandatory annual process for companies that produce or distribute medical devices in the U.S. It ensures that firms comply with FDA regulations to legally market their devices.
Who needs to pay the annual FDA registration fee?
Companies involved in manufacturing, packaging, labeling, or reprocessing medical devices in the U.S. must pay an annual registration fee.
What is MoCRA and how does it affect Cosmetics facilities?
Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Most facilities will need to register and comply with GMPs issued by FDA.
Are there any exemptions for cosmetic facility registration?
Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that come into contact with eyes, are injected, are intended for internal use, or alter the appearance for more than 24 hours under conditions of use that are customary or usual.
When are cosmetic facility registrations and product listings required?
For existing facilities, facility registration and product listings are due by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later.
Are there any FDA fees involved for food and supplement registrations?
No, the FDA does not charge initial or annual fees for food facility registration. The only fees paid will be those of registering agency service fees.
Does the FDA issue Registration Certificates?
Once a company is registered, FDA issues registration numbers but does not provide Certificates of Registration. Yet many buyers or importers still request registration confirmation from their suppliers.
If your facility has already registered with FDA, FDA Agent Pro can provide a third-party Certificate of Registration to serve as confirmation of your valid FDA registration to buyers, customs brokers, and suppliers. We currently offer third-party Certificates of Registration for companies in the food and beverage, drug, and cosmetics industries.
If your facility is not registered with FDA, consider working with us to register your facility and obtain a third-party Certificate of Registration.
If your facility has already registered with FDA, FDA Agent Pro can provide a third-party Certificate of Registration to serve as confirmation of your valid FDA registration to buyers, customs brokers, and suppliers. We currently offer third-party Certificates of Registration for companies in the food and beverage, drug, and cosmetics industries.
If your facility is not registered with FDA, consider working with us to register your facility and obtain a third-party Certificate of Registration.
Who needs to register with the FDA?
FDA Registration is mandatory for domestic and foreign food facilities that manufacture, process, pack, or store food for consumption in the US. Registration ensures the FDA can quickly identify and contact facilities in the event of a public health issue. Non-compliance may lead to import detentions or refusal of entry. If you produce products in the categories below, FDA registration may be mandatory:Food & Beverage (Including dietary supplements and animal food)Medical devicesDrug products (including OTC)Tobacco productsRadiation-emitting devices (RED)BiologicsEach product category has specific exemptions and Registrar Corp can help you determine whether you must register your facility. Some facilities, like Food & Beverage producers, must register with FDA before shipping products to the U.S. and renew their FDA Registration every even-numbered year between October 1 and December 31.
Does a domestic food facility require FDA registration?
YES, The Bio-terrorism Act requires US FDA registration for domestic food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic food facility is required to register the facility with the US FDA. Domestic facilities require FDA registration whether or not food from the facility enters interstate commerce.
Does FDA registration number denote US FDA approval??
No, FDA registration number does not denote FDA approval, U.S. FDA will assign a unique registration number to each registered facility.
Does FDA registration number expire?
No, U.S FDA registration number does not expire, But biennial registration renewal is required as per new FSMA act.
Does each food product get an FDA registration number?
No, U.S FDA will assign an FDA registration number to each food facility, not for each food product.
FSVP SERVICES
What is the Foreign Supplier Verification Program (FSVP)?
The FSVP is an FDA regulation that requires US importers to verify that their foreign suppliers produce food that meets US safety standards. This includes ensuring the food is not adulterated or misbranded and complies with the Food Safety Modernization Act (FSMA).
Why do I need an FSVP Agent?
If you’re a foreign supplier shipping food products to the US, you are required to designate a US-based FSVP Agent to ensure compliance with FDA regulations. An FSVP Agent handles verification, record-keeping, and communication with the FDA on your behalf, helping you avoid penalties or import delays.
What’s required for FSVP compliance?
Qualified Individual on staff (at least 1), FSVPs for all products sold in U.S., Continuous monitoring of suppliers, and Consultation and support for maintaining U.S. FDA compliance
FDA EXPORT CERTIFICATE SERVICE
How We Help You Obtain an FDA Export Certificate?
FDA Agent Pro can help you obtain an expert certificate for your product. Before we do so, we gather information to verify whether you qualify to receive the export certificate.
Eligibility Review: We evaluate your product and determine certificate eligibility.Document Preparation: We assist with label reviews, facility registration, and U.S. agent services.FDA Submission: We file the certificate request with the FDA on your behalf.Follow-Up & Delivery: We track the status and send your approved certificate via courier or digital download.
What Conditions Prevent The FDA From Issuing An Export Certificate?
The FDA reviews records for relevant establishments and products when deciding whether to issue export certification. The FDA will only issue the certification if it finds that the establishments or products are eligible, such as noncompliance with CGMP, lack of proper registration and listing, or enforcement actions in place.
Who Needs an FDA Export Certificate?
- Food and Beverages: Includes conventional foods, dietary supplements, and ingredients.
- Pharmaceuticals: Encompasses both prescription and OTC drugs.
- Medical Devices: Range from Class I simple devices to Class III, such as MRI machines.
- Cosmetics: Covers skincare, makeup, and personal care products.
- Veterinary Products: Includes animal drugs, feeds, and devices.
- Biologics: Includes vaccines, blood products, and gene therapy products.
- Tobacco Products: Encompasses cigarettes, cigars, and other tobacco-based products.
- Different types of export certificates issued by the FDA may have different titles and follow a particular template are listed below:
- Certificate to Foreign Government: issued for exporting human food, human drugs, animal drugs and feed, and medical devices that meet the applicable marketing requirements in the United States.
- Certificate of Exportability: This document allows the legal export of food, human drugs, animal drugs and feed, and medical devices not approved for marketing in the United States but comply with the requirements of sections 801 or 802 of the FD&C Act.
- Certificate of a Pharmaceutical Product: This certificate is for human and animal drugs. It follows the format set by the World Health Organization (WHO) and is commonly used by the importing country to assess whether to approve the drug for sale within that country.
- Certificate for Cosmetics: This certificate is issued for products that meet the US definition of cosmetics. It cannot be issued for products that make therapeutic claims on their label, such as cleansers marketed for acne treatment.
- Certificate of Free Sale (CFS): issued for human dietary supplements, medical foods, foods for particular nutritional use consumption, animal food, animal drugs, or medicated animal feed that are regulated by the FDA and can be legally marketed in the United States.
- Health Certificate: Foreign governments may request health certificates for human foods with animal-derived ingredients, often seeking FDA statements on compliance with foreign regulations. Generally, the FDA does not issue certificates confirming compliance with another country’s requirements but may work with other governments to create acceptable language for health certificates, such as those for collagen or gelatin products exported to the EU. Requests for new health certificates are considered on a case-by-case basis.