Detailed! US FDA Registration Process and Requirements

Release time:

2024-04-24 15:47

FDA registration can also be called FDA registration, which means that cosmetics, medical devices, food, lasers, LED lamps and other products exported to the United States must be registered with the Federal Food and Drug Administration of the United States, and ensure that the products meet the relevant standards and health and safety requirements of the United States. Its registration process and requirements are relatively complex and rigorous.

Registration process

1. Get the DUNS number:Prior to FDA registration, companies need to obtain a DUNS (Data Universal Numbering System) number, which is a globally unique identification number provided by Dun & Bradstreet.

2. Create an FDA electronic portal account:Visit the FDA Unified Registration and Listing System (FURLS) to create an account.

3. Submission of application for registration:To use a FURLS account, complete and submit the appropriate registration application form. The form will require the necessary business information, product information, manufacturing/import process, quality control measures, etc. The specific requirements of the application materials depend on the type of registration and the type of product.

4. Payment of fees:Pay the appropriate registration fee according to the type of registration selected and the relevant regulations.

5. Approval and registration number:The FDA will review and evaluate the registration application and may request additional materials or provide further information. If the application is approved, the FDA will provide the registration number.

Registration Requirements

1. Registered enterprises:The enterprise must be a legally established and legally operating entity with a business license or legal registration certificate.

2. Person in charge:Businesses need to designate a responsible person (US Agent) who is responsible for communicating with FDA and representing the business.

3. Production sites and facilities:The company's manufacturing sites and facilities must meet FDA requirements, including good sanitary conditions, appropriate equipment and processes.

4. Quality management system:Companies need to establish and implement an effective quality management system to ensure that product quality meets FDA requirements, including record retention, traceability, and adverse event reporting.

5. Technical documents and data:Enterprises need to provide sufficient technical documents and data to support the safety, effectiveness and quality of products, including product specifications, design documents, test data, clinical trial data, etc.

6. Labels and instructions:Companies need to design and produce product labels and instructions for use in accordance with FDA requirements to ensure accurate and clear communication of product information and instructions for use.

Please note that specific registration requirements and procedures may vary based on product type, application category, and FDA's latest policies. Therefore, when conducting FDA registration, it is recommended that companies consult the official FDA website in detail or contact a professional FDA registration consulting agency to ensure that the application is carried out in accordance with the latest regulations and requirements.

What is FDA Registration? How is FDA Registration?

What is FDA registration? What are the requirements for FDA registration?

What is FDA Registration? How is FDA Registration?

What is FDA registration? What are the requirements for FDA registration?

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