How To Get an FDA Certification in Philippines?

  • FDA Certification is a must for the manufacturers of food, drug, or medical devices in the USA. It is a fundamental requirement for domestic and foreign establishments to market their products in the United States. Establishments that manufacture cosmetics do not need FDA registration mandatorily. But they can participate in the VCRP (Voluntary Cosmetic Registration Program) of the FDA. Call @ +6531591803

    The Food and Drug Administration (FDA), stands for an agency in the US designated to ensure the safety of a wide variety of consumer products. This regulatory agency, established under the Federal Food and Drugs Act of 1906, has a fairly wide scope in different industries, such as:

    • Food and beverages
    • Cosmetics
    • Drugs and/or pharmaceuticals
    • Medical devices
    • Vaccines
    • Household hazardous products
    • Pesticides

    FDA Registration: Necessity and Cost

    Generally, an organization or its products involved in any of the following activities in United States for the above listed product categories requires FDA registration annually.

    • Importing
    • Exporting
    • Wholesale trading
    • Distribution
    • Manufacturing

    Annual FDA Registration Fee is around $5,546. There are no renunciations or reductions for small organizations, businesses, or groups – all institutions have to pay the registration fee to FDA.

    General procedure followed in FDA registration

    FDA certificate registration is done through Centre for Food in the FDA central office. The Licence to Operate (LTO) is, at first, valid for one year.  After renewal, the LTOs will be valid for two years. The following document is minimum required for FDA registration:

    • A notarized petition-form
    • Certificate of Attendance to a seminar on licensing of establishments sponsored by FDA.
    • Proof of business registration
    • Proof of occupancy or business address to be given
    • Documents about the business location itself including a floor plan with dimensions

    IAS can assist in preparing and securing the above documents in UAE too. Our team will apply for the LTO on your behalf. You can fill out the bellow form and one of our counsellors will get in touch with you.