Domestic and foreign establishments that manufacture, repack, distribute or re-label certain drug, food, medical device, and cosmetics may require registration with FDA. The requirement for each type of registration may vary. For example, The owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Products that may require FDA registration are:

✪    Animal and Veterinary Drugs

✪    Cosmetics (Voluntary)

✪    Drugs

✪    Food

✪    Medical Devices

✪    Radiation-Emitting Products

✪    Tobacco Products

✪    Vaccines, Blood, Biologics

Responsibilities of a U.S. Agent:

Our service includes:

✔    Registration Processing

✔    US FDA Registration Number Notification

✔    Product Classification

✔    Annual FDA Registration Renewal Processing