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US FDA Registration Certificate

An FDA certificate is an important step to establish trust among consumers and suppliers if you want to manufacture your medical devices in the US (or export them). It is issued as an external validation of FDA registration & validity (for foreign manufacturers) done by a trusted agency like Cert3global. Although the FDA does not issue it and is not mandatory, it has some crucial benefits for your quality assurance and market access.
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What is an FDA Certificate?

It is an ‘external’ certificate that:

  • validates the registration number and registration validity date (which are issued by the FDA) for foreign manufacturers looking to export to the United States. Often required by customers or suppliers for their validation.
  • Validates that the certified organization is capable of consistent production of quality products that adhere to the Food and Drug Administration Standards.

Does FDA Issue Certificate?

It is important to note that:

 

  • Issued by an external agency (like Cert3global), not officially issued  by the FDA (also not considered legally valid nor recognized by the FDA)
  • FDA  issues certificates to Domestic US manufacturers only. (to ensure smooth acceptance of US products in other countries)
  • Use of the term “FDA Approved” by foreign manufacturers on Primary Labels, Secondary Packages, and Websites is incorrect and not accepted by the FDA.


Cert3global is a team of US FDA Agents and regulatory consultants with offices in the USA, Germany, and India. We can provide you with third-party certificates that validate your registration status.
To Obtain a certificate, you can reach out to us by writing an email or submitting the quick contact form.

We strive to organise the certificate within six hours during working days and our certificate charges start from 350 USD.


What is the Validity of the Certificate issued by an External Agent?

It is valid for one year from the issue date. However, the validity can be extended upon request and payment.

Why FDA Certificate is needed?

Suppliers and Customers often require it to validate the registration number and registration validity date, especially for food manufacturers and exporters. It is an Assurance of Public Health, Regulatory Compliance, and Quality Control. It increases Consumer Trust and market access opportunities.

Mandatory FDA Certification for Medical Devices

It is mandatory for medical device manufacturers who want to sell their products in the United States. There are stringent sets of guidelines that medical device manufacturers must meet before their products can be FDA-certified to ensure that medical devices distributed in the US meet specific safety and efficacy benchmarks.

Cert3global: Your FDA certificate Partner

If you are looking for experienced regulatory experts, then our streamlined certification process will suit your needs. Contact us to start the process of increasing your market access and enhancing your brand reputation.
  • It is an external certification (issued by trusted partners like cert3global) to verify a foreign manufacturer’s registration number and validity with the FDA.
  • It is issued by the Food and Drug Administration to domestic US manufacturers only.
Validity is one year (when obtained from external agencies like cert3global). However, validity can be extended upon request and payment.
Costing depends and varies with the type of device being considered. We can help you know the exact cost of your device. Just contact us and we are happy to help you out.
As the certificate is issued by an external agency like cert3global, not by the FDA,so advertising your facility as FDA-certified is not correct.
To establish trust of quality and regulatory compliance among suppliers, end consumers and increase market access to new geographies smoothly.
FDA Color Certification is required for all colour additives, except coal tar hair dyes before they can be used in food, drugs, or cosmetics. It is issued after thorough analysis at designated facilities by the FDA based on test results.