FDA registration requirements made easy.
The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by regulating imported products. Any company that plans to distribute drugs, medical, and select other products for the U.S. market is required to register with FDA.
If you produce products in the categories below, FDA registration may be mandatory:
- Medical devices
- Drug products (including OTC)
- Tobacco products
- Radiation-emitting devices (RED)
- Biologics
Each product category has specific exemptions and Registrar Corp can help you determine whether you must register your facility.
By registering your facility with FDA, you help promote consumer safety and keep your company FDA compliant. FDA registration involves submitting detailed information about your products, manufacturing facilities and processes, quality control, labeling, recall procedures, and more.
FDA compliance can seem time consuming and complex, but it doesn’t have to be. More than 30,000 food and beverage, dietary supplement, drug, medical device, and cosmetics companies trust Registrar Corp to help them comply with FDA registration regulations with ease.
Drug Facility Registration | Medical Device Registration|Other FDA Registrations
Certificate of Registration | Verify Your FDA Registration | Affirmation of Compliance
Dietary Supplement Facility Registration
Dietary supplements fall under FDA jurisdiction as part of the food and beverage industry. This means if you’re a dietary supplement manufacturer, processor, packager, or warehouse facility trying to enter the U.S. market, you need to register your facility with FDA.
Like food and beverage facilities, dietary supplement manufacturers, processors, packagers, and warehouse facilities 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.
Master Manufacturing Records
Companies that manufacture dietary supplements must write and implement Master Manufacturing Records (MMRs) for each unique formulation and batch size of dietary supplement. MMRs identify steps and stages in the manufacturing process for each supplement to ensure consistency in the components, quality, labeling, and packaging of the supplement across batches.
Registrar Corp’s Dietary Supplement Registration Services
Our FDA Facility Registration services for dietary supplement companies consist of:
- FDA Registration and Renewal assistance
- DUNS number assistance
- 24/7 U.S. Agent representation
- Prior Notice filing
- Mock FDA Inspections
- MMR compliance review
Drug Facility Registration
Registering your drug establishment with FDA helps you bring safe and compliant products to market. FDA registration is mandatory for all domestic and foreign companies that manufacture, prepare, propagate, or compound drug products for commercial distribution in the U.S.
Drug establishments must register with FDA before shipping to the U.S. and must renew their registration annually between October 1 and December 31. In addition, establishments must submit a list of every drug in commercial distribution in the U.S. when they renew.
Drug Master File Submissions
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 the National Medical Products Association (NMPA) in China.
Drug Master Files (DMFs) include information on:
- Drug substances and products
- Packaging materials
- Excipients and preparation materials
- Facilities and their procedures
- and More
Registrar Corp offers DMF preparation in electronic common technical document (eCTD) format and submission to 18 regulatory bodies worldwide.
Registrar Corp’s Drug Facility Registration Service
With our FDA Registration services for drug facilities, you receive:
- FDA Registration and Renewal assistance
- DUNS number assistance
- 24/7 U.S. Agent representation
Medical Device Registration
Knowing what medical devices are available can impact the U.S.’s ability to respond to public health emergencies. All establishments involved in producing and distributing medical devices intended for use in the U.S. need to register with FDA.
Medical device companies are required to register with FDA before shipping products to the U.S. and must renew their registrations annually between October 1 and December 31.
Medical Device Master File Submissions
Similar to Drug Master Files, Medical Device Master Files (MAFs) contain proprietary product data that is securely submitted to national and international regulatory agencies.
MAFs include information on:
- Facilities and their procedures
- Device formulations
- Packaging materials
- Clinical and non-clinical study data
- and More
Registrar Corp offers MAF preparation in electronic common technical document (eCTD) format and submission to 18 regulatory bodies worldwide.
Registrar Corp’s Medical Device Registration Services
With our FDA Registration services for medical device facilities, you get:
- FDA Registration and Renewal assistance
- UDI and GUDID assistance and compliance
- 24/7 U.S. Agent representation
- Electronic Medical Device Reporting (eMDR)
Other FDA Registrations
Along with food and beverage, cosmetic, drug, medical device, and dietary supplement establishments, Registrar Corp can help companies in the following industries register with FDA:
- Radiation-emitting devices
- Tobacco
- Biologics
Certificate of Registration
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, Registrar Corp 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 Registrar Corp to register your facility and obtain a third-party Certificate of Registration.
Verify Your FDA Registration
FDA registration numbers can become invalid unexpectedly and cause delays or detentions at ports of entry. Reasons your FDA registration number may be invalidated include:
- Outdated ownership or other information
- Registration not submitted by authorized person
- Facility’s U.S. Agent refusing the designation
- Registration not renewed before renewal deadline
At Registrar Corp, we provide U.S. FDA registration verification at no additional cost. You can quickly and easily check whether your facility’s registration is valid and take corrective action to prevent potential fees or fines.
Affirmation of Compliance
When a product arrives at a U.S. port of entry, certain information must be provided and transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by FDA, CBP sends the import entry information to the FDA for verification.
Appropriate Affirmation of Compliance (AofC) codes and qualifiers can expedite the admissibility process. While the use of these AofC codes is voluntary, it will help expedite the entry review process and increase the likelihood that the shipment may be processed based on import system screening.