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US FDA

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Free FDA Registration Services!
We charge only Annual US Agent Fee.

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FDA Registration Services via I3CGLOBAL can avoid conflicts when you are working with multiple distributors or agents.  We assure permanent FDA compliance with regulations time by time, year by year, no matter your commercial relationship with distributors and importers in the USA.

US FDA Registration Process

All facilities involved in the processing of food, drugs, medical devices, cosmetics must complete the US FDA Registration. The requirements are from the U.S.Food and Drug Administration. Failure to register will prevent entering the US market. All foreign facilities must name a US Agent when registering the facilities.

We Provide FDA Registration Services To Below Industries

Business owners and their places of activity, so-called establishments or facilities, engaged in any activity which affects the quality of the product such as repacking, re-labeling, storage or production in any of the FDA regulated industries must REGISTER with the FDA.

Drugs

The following type of establishments can approach us for FDA Registration.

 

  1. Over-the-counter Drug manufacturers and exporters
  2. ANDA/NDA approved drug product manufacturers
  3. Active Pharmaceutical ingredient (API) manufacturers and exporters
  4. Medicated cosmetics manufacturers and exporters
  5. Analytical Test facilities
  6. Biologicals

 

We help manufacturers planning to export Over-the-counter (OTC) drugs. These products are generally safe and classified under ‘Generally Recognized as Safe and Effective’ (GRASE). No additional requirements are other than Establishment Registration, NDC, and Listing.

 

DUNS Number is mandatory to proceed with FDA Drug Establishment Registration.

 

More detailed information about the Drug Establishment Registration.

 

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It is important to know that the FDA Registration for Medical Device(s) can be initiated for:

 

  1. Direct FDA Registration is permitted only for 510k exempted devices.
  2. 510k non-exempted devices can be registered only after 510k clearance

 

Medical Device Name, Device FDA Code, FDA regulation Number, Class of the device, Intended use, the propitiatory name is required for completing the registration process.

 

More detailed information about the FDA Medical Device Registration & Listing.

 

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Food (Human & Animals)

Attention – Manufacturers, Exporters, Distributors & Importers of food items to the USA.

 

The following type of products only can be registered.

 

  1. Human & Animal food for consumption
  2. Food Supplements or Nutraceuticals
  3. Food Ingredients
  4. Acidified & Canned foods
  5. Organic Certified Food products

 

More Information about Food Facility FDA Registration.

 

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FDA Registration for Cosmetics

 

FDA Registration for Cosmetics can be processed only if the cosmetics are already available in the USA.

 

FDA Registration is Voluntary. The regulation is called Voluntary Cosmetic Registration Programme. VCRP can be applied by the manufacturer of the cosmetic product and the brand owner.

 

More detailed Information about VCRP.

 

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