FDA Certification in Australia

About FDA Certification

Under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), any beverage container containing a nutrition or health claim must be approved by the FDA. If you promote your product in the United States, regardless of where it was produced, you might be held liable under the FDCA for false or misleading label representations. If the FDA finds your claim to be “false and misleading,” it has the power to order you to stop selling the product with that labeling. In rare cases, the FDA may even ask the Justice Department to file criminal charges.

Integrated Assessment Services (IAS) can assist you in obtaining FDA certification. Manufacturers can get FDA registration and a verified registration number with our help. IAS also helps makers of food, pharmaceuticals, and medical devices register with the US Food and Drug Administration. We offer high-quality services at a price that is both affordable and competitive. Your organization can become compliant with FDA policies with the help of IAS.

What is the Main Difference between FDA Registration and FDA Certification?

There are distinct FDA registration and FDA certification requirements. Registration is necessary for FDA-regulated items such as dietary supplements and medical equipment. Although FDA approval of nutritional claims on the label is necessary (e.g., “gluten-free,” “fat-free,” or “natural”), FDA certification is not required. FDA Registration and FDA Certification are two methods for ensuring that a company’s goods comply with FDA regulations.

Before you may apply for FDA certification, you must first register with the agency. The FDA registration of your company confirms that it conforms to FDA standards and regulations. It certifies that your products are legal to sell in the United States. This approach is required for FDA certification regardless of the number of goods manufactured.

Which Organizations Can Apply for FDA Certification?

The FDA allows food facilities, pharmaceutical companies, dietary supplement manufacturers, and medical device manufacturers to register for FDA certification. To sell medical equipment and pharmaceuticals in the United States, manufacturers must first register with the FDA. Companies that make cosmetics can register with the FDA, but it is not necessary.

You must first register in order to sell your products in the United States. While FDA certification is not needed for food items, FDA certification is required for food manufacturers. In addition, new medicines and dietary supplements must be approved by the FDA. The Food and Drug Administration (FDA) examines the following considerations before approving a product for FDA certification:

  • Site inspections, procedural inspections, and the execution of the required processes.
  • Clinical trials, test results, study publications, and research methodologies are all available.

How to Obtain an FDA Registration Number?

One of the most essential criteria for firms seeking to market their products in the United States is to get an FDA registration number. Despite the fact that FDA clearance is necessary, medicines and medical devices do not require an FDA registration number. It’s a one-of-a-kind registration number that verifies the company’s registration with the US Food and Drug Administration. It does not imply that the company or product has received FDA approval.

A registration certificate is not issued by the FDA. IAS will assist you in obtaining FDA clearance for your business. We provide you a registration certificate, which states:

  1. The FDA registration procedure has been completed successfully.
  2. Your business has been approved by the FDA.
  3. Your FDA registration number is current and can be used on the market.

Process for FDA Certification through IAS

  1. Choose if you want individual FDA certification or a single product with numerous certifications.
  2. To discuss the details of FDA certification, please contact us with the completed Application form.
  3. The maker or merchant submits the initial documents (Based on FDA Certification standard, including test certificates)
  4. Examine the documents to check if it complies with legal requirements.
  5. Conduct an audit to confirm that the product complies with FDA certification standards.
  6. Final paperwork, as well as any further clarifications that may be required, must be submitted.
  7. The paper is then reviewed and approved.
  8. The FDA issues a compliance certificate.

Click here to learn more about our FDA Certification procedure! For further information on FDA certification, see the frequently asked questions.