FDA Registration
US FDA REGISTRATION
US FDA Registration is mandated by the united states food and drug administration department, responsible for monitoring and protecting public health from inferior quality consumer products such as drugs, medical devices, food, and cosmetics. Appointing us as FDA Agent can avoid conflicts when you work with multiple distributors, Importers, and agents. We assure permanent FDA compliance with regulations over the period, no matter your relationship with distributors and importers in the USA.
Every company that makes a product for sale in the USA is required by law to register with the FDA. This assures that all items sold in the United States meet a set of quality criteria. Registration benefits both consumers and companies. Those register with the FDA are eligible for a variety of marketing advantages that might help them boost their overall business and exports to USA as well as other countries.
WHAT KINDS OF PRODUCTS DO YOU NEED TO GET FDA APPROVAL?
FDA approval is conditional on the sort of product being sold in the United States. FDA certification is not required for all types of items. The goods that require FDA certification are listed below.
- Food Certification by the FDA
Food products do not need FDA certification, but food processing facilities must register with the FDA. The FDA does not require any form of certification for the product before it may be distributed in the United States.
Officials from the Food and Drug Administration (FDA) travel to India to inspect food and pharmaceutical manufacturing facilities. The official verifies that the plants are in accordance with the FDA's guidelines.
- Drug Approval from the FDA
The FDA examines the drug to see if it complies with the Over-the-Counter (OTC) monograph. Drugs must be both safe and effective. The OTC monograph specifies the parameters under which the drug items are safe and effective to use. monograph (OTC)
On the other hand, if the new medicine does not conform with the OTC monograph, FDA certification will be required. Drug makers undergo lab, human, and animal testing before submitting the results to the FDA. The FDA will analyze the information given and may grant the product FDA certification.
- Cosmetics with FDA Approval
Cosmetics and its ingredients (apart from Color Additives) do not require FDA approval before being marketed. Cosmetics companies are not required to register with the FDA, but their products must be safe for customers to use.
Certain cosmetic claims may cause the FDA to regulate the cosmetic product as a drug product, and in some situations, this may result in the cosmetic product receiving an FDA approval certificate.
- Color Additives Have Been Approved by the FDA
FDA certification is required for colour additives used in food, drugs, some medical devices, and cosmetics. Color batch certification from the FDA is required for some high-risk colours. The use of colour additives is limited to FDA-approved compliances. The FDA has placed restrictions on dangerous colour additives.
- Medical Devices That Have Been Approved By The FDA
The FDA categorizes medical devices into three risk categories. The following are the categories: Class I, Class II, and Class III are the three levels of classification. Medical gadgets in the Class III category are the most dangerous. Only FDA certification is required for these Class III devices. Class III medical device makers should reassure the FDA that their products are safe and effective to use.
DOCUMENTS REQUIRED FOR FDA CERTIFICATION
The documents required are as follows-
Entry Documentation
- Airway Bill
- Bill of Lading
- Invoice
- Purchase Order
Commodity Specific Documentation
- Any other document as requested.
- Documentation stating the identity of the actual owner of the product
- Growers List
- Labelling Copies
- Packing List
- The statement of the intended use or end use of the product
US FDA REGISTRATION PROCESS
All facilities involved in the processing of food, drugs, medical devices, and cosmetics for sale in USA, must complete the FDA registration & approval. The requirements are from the U.S. Food and Drug Administration. Failure to register will prevent entering the US market. All foreign facilities must name a US Agent when registering the facilities. The FDA Registration Process may feel intimidating, so we’re here to help you know exactly what you need to do to make the process go smoothly.
The US FDA registration procedure is a demanding task that demands patience and caution while entering and submitting facility information online. It’s critical to realize that customers are not simply seeking any firm; they want to be certain that the goods you are selling are reliable and secure. The FDA wants to be certain that you are able to produce items in a GMP facility and in an acceptable way with quality as a primary consideration.
The manufacturer’s information and the relevant person’s contact information must be submitted as the initial stage in the registration procedure. Additionally, you must disclose information on the manufacturing process, product specifications, product codes, regulatory number, and labelling information as necessary for the items.
Once the mandatory information is submitted along with the DUNS number, the FDA will issue a registration number. Cosmetics and food facility registration details are not published on the FDA website, whereas medical device and drug establishment registration details will be published there. If they approve it, then congratulations! You can move onto the planning phase for exporting goods. Remember that exported goods must comply with FDA labelling regulations.
- Identify the product for U.S. distribution
- Contact Regulatory expert to review the product Information panel/labels and DUNS number
- US urgent appointment followed by establishment registration and listing
- Verify registration details and export to USA
