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Does Your Product Need to be Licensed with the Philippine FDA?
Products Need to be Licensed with the Philippine FDA

Does Your Product Need to be Licensed with the Philippine FDA?

Businesses that wish to engage in import, export, or distribution of products in the Philippines must plan for FDA registration during the set-up phase of the business. Several product categories are regulated by the FDA, and products that fall within these categories require product registration. It is helpful for business owners to determine where their products fall under existing categories, in order to be able to comply with the law. Companies can avoid mishaps during the process by engaging the assistance of an FDA registration expert. At Kittelson & Carpo Consulting, our FDA consultant is a licensed pharmacist who has considerable expertise in various areas of product registration in the Philippines. She can provide seamless assistance in securing the right types of licences for your product and facilitating its approval for trading in the country.

Processed Food and Food Supplements
Processed foods have been changed from their natural state. Processed foods refer to foods packaged in boxes, cans, or bags, which usually contain additive artificial flavorings and other chemical ingredients. These are foods prepared to be edible and are not found as is in nature. FDA normally checks the ingredients of of powder mix, starch, juice, carbonated drinks, syrup, sauce, wine, jarred fruit, frozen meat, crackers, canned fish, food supplements, margarine, oil, and many more. The longer the ingredient list, the more processed a food is likely to be.

Drugs are substances containing medicinal, intoxicating, performance enhancing, or other ingredients when taken into a human or animal body. The FDA examines drugs used for treatment, cure, prevention of disease, or physical or mental enhancements, as well as recreational drugs or substances that affect the central nervous system such as hallucinogens. Examples of drugs requiring licensing include Carbocisteine, Cefalexin, Ambroxol, Guaifenesin, Mefenamic, Multivitamins, Paracetamol, Dextrose, Sodium Chloride, Alcohol, Amino Acids, Ointments, and many more.

Some countries include cosmetics within the legal definition of drugs for registration purposes. However, in the Philippines, cosmetics are classified separately from drugs. Cosmetics are a mixture of chemical compounds used to enhance or improve a person’s appearance. Similar to the definition the United States uses, the Philippine FDA considers articles that are rubbed, poured, sprinkled, sprayed or applied to the human body, without affecting the body’s structure or functions, as cosmetic. Items include creams, lotions, powders, body oils, lip balm, soap, cologne, perfume, shower gel, hair color, deodorant, and many more.

Medical Devices
Medical devices that are imported into the country for sale and trading in the Philippines are evaluated by the country’s FDA. These instruments range from simple tongue depressors and bed pans, to complex electronic pacemakers with microchip technology and laser surgical devices. In Vitro Diagnostics or IVD products, such as lab equipment, reagents, and test kits are also evaluated before they were authorized for use in clinics. Finally, before devices that are capable of emitting electronic radiation such as diagnostic ultrasound products, x-ray machines, and medical lasers can operate, they undergo evaluation by the FDA.

Household – Hazardous Substance, Urban Hazardous   
Haphazard substances such as bathroom and tile cleaners, dishwashing liquid, wax, paint, detergent powder, sanitizer, insect killer, repellent, bleach, deodorizer, air freshener, and more, are carefully inspected by the FDA before they are distributed to the market and available for purchase by consumers.

Urban Hazardous household chemicals in the forms of instant superior bond glue, car spray, roof sealant, tire polish, and more also receive extensive inspection before they are licensed.


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