FDA Certification

About FDA Certification 

The FDA must approve any beverage container with a nutrition or health claim under the Federal Food, Drug, and Cosmetic Act (the “FDCA”). If you market your product in the United States, regardless of where it’s made, you could be held accountable under the FDCA for making sure your label statements are true and not misleading. If the FDA determines that your claim is “false and deceptive,” it has the authority to require you to stop selling the product with that labeling. In some situations, the FDA may even request that the Department of Justice seek criminal charges.

FDA Certification

Integrated Assessment Services (IAS) can assist you in obtaining FDA certification in Canada. 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.

Who can Apply for FDA Certification in Canada?

Food facilities, pharmaceutical firms, dietary supplement producers, and medical device manufacturers can all register with the FDA. Manufacturers must first register with the FDA in order to sell medical equipment and drugs in the United States. Cosmetics companies can also register with the FDA, although it is not required.

In order to sell your items in the United States, you must first register. Although FDA certification in Canada is not required for food products, it is required for food manufacturing companies. In addition, the FDA must approve new medicine and nutritional supplement items. In order to approve a product for FDA certification in Canada, the Food and Drug Administration (FDA) considers the following factors:

  • Inspections of the site, inspections of the procedures, and the implementation of the appropriate processes.
  • Clinical studies, test findings, research articles, and methods for future research are all available.

What is the difference between FDA Registration and FDA Certification?

There are separate FDA registration and FDA certification criteria. For FDA-regulated products, such as nutritional supplements and medical devices, registration is required. FDA certification is not required, although it is required for FDA clearance of nutritional claims on the label (e.g., “gluten-free,” “fat-free,” or “natural”). Both FDA Registration and FDA Certification are procedures for making a company’s products FDA compliant.

Before you seek FDA certification for your company, you must first obtain FDA registration. Your organization’s FDA registration verifies that it complies with FDA requirements and regulations. It confirms that your items are safe to distribute in the United States. Regardless of the number of products manufactured, this method is essential for FDA certification.

What is the procedure for obtaining an FDA registration number?

Obtaining an FDA registration number is one of the most important requirements for businesses wishing to market their products in the United States. Despite the fact that FDA certification is essential, the FDA registration number is not required for drugs and medical devices. It’s a one-of-a-kind registration number that proves the business is registered with the Food and Drug Administration in the United States. It does not mean that the business or product has been approved by the FDA.

The FDA does not issue a registration certificate. IAS will help you gain FDA approval for your company. We provide you with a registration certificate that means:

  • The procedure for FDA registration has been successfully filed.
  • Your company has obtained FDA registration.
  • Your FDA registration number is valid to use in the market.

Once you successfully achieve FDA certification, you can check the status of your certificate by visiting our FDA certification search Page!

How to Apply for FDA Certification in Canada through IAS

  • Choose if you want FDA certification in Canada for individual goods or for a single product with multiple certifications.
  • Please contact us with the completed Application form to discuss the details of FDA certification in Canada.
  • Initial documentation is submitted by the manufacturer or trader (Based on FDA Certification standard, including test certificates)
  • Check to see if the documentation meets the legal standards.
  • Conduct an audit to ensure that the product meets the FDA certification requirements.
  • Final documentation must be sent, as well as any additional clarifications that may be needed.
  • The completed document is evaluated and approved.
  • FDA certification of compliance is granted.

Click here to learn more about our FDA Certification Audit procedure and FDA Certification Process! Also, see the FDA certification frequently asked questions page to learn more!

Also check out our blog on how to get ISO Certification!