What is an FDA registered company?

To market your products in the United States, as a manufacturing company of food, drug or medical device you should register with the FDA (Food and Drug Administration). It is the world’s most recognized federal agency in the US. It is solely responsible for protecting the public health by ensuring the safety of food, dietary supplements, drugs, etc., that are manufactured in the United States as well as that are sold within the US. FDA Certification is mandatory for product manufacturers to market as well as export their products to the US. FDA approval is important for the new drug products, biological and dietary supplements to gain market access. Also, the FDA approves new medical devices and some of the high-risk medical devices.

FDA, the federal agency does not issue the FDA registered certificate. FDA registration is an essential requirement to promote your products in the US. The certification proves that you are registered with the US FDA. Also, it is important to note that FDA registration does not mean that your organization or products approved by the FDA.

Companies that require FDA Certification

FDA registration number is an 11 digits unique code.  So, each organization will get a different number. This unique identification number helps you market your products in the United States. Also, it is a must for the manufacturer of food products should get this FDA registration number to export your products to the US.

FDA Certification is a key requirement for the manufacturers of:

  • Foods
  • Dietary supplements
  • Drugs
  • Vaccines
  • Medical devices such as medical gowns, gloves, face masks, N95 masks, etc.
  • Radiation- emitting electronics
  • Color additives
  • Also, veterinarian products and so on. 

The registration is a voluntary process for the manufacturers of cosmetic products. But if it gets registered, you can stand alone in the global business market and promote the reputation of your brand.

Registering with FDA is also important for the organizations that re-pack or re-label and distribute the above-mentioned products.

How to get FDA Certification in Indonesia

The requirements for FDA registration vary from one organization to another.

  • Contact IAS to get complete guidance about the specific process for your organization
  • We assist you with necessary guidelines to complete your registration with FDA
  • The process of FDA registration is different for each manufacturer
  • We assess and also verify your organization, products, etc. to help you get the registered certificate

Validity of the FDA registration certificate

The FDA registration certificate that we provide for food companies is valid for 2 years. For manufacturers of drugs, medical devices, etc., the initial certificate has 1 year validity. All registered organizations should renew their certification to comply with FDA renewal regulations. We also help you with the renewal of the FDA registration certificate.

Choose IAS to get FDA Certification

Registering your company with FDA becomes simple with IAS. IAS is a recognized organization in Indonesia for supporting the manufacturers to get FDA Registration. Our experts also help with required guidelines and FDA regulations to register your organization with the Food and Drug Administration. We help you get 100% satisfaction with your FDA registration.

Looking for more details about the FDA certification? Kindly contact us!

 

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