Food and Drug Administration of the Philippines
The national health product regulatory agency of the Philippines that regulates the drugs, medical devices, food, cosmetics and toys, and household/urban hazardous substances.
License to Operate
Authorization issued by the FDA to a person or establishment to operate as a manufacturer, trader, distributor/importer/exporter/wholesaler of medical devices.
Product Registration
The process of approval of an application to register food products, food supplements, drugs, medical devices and household/urban pesticides prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of said products.
Product Notification
The process notifying the FDA of one’s intent to manufacture, import, export, sell and/or distribute cosmetic products, select household/urban hazardous substances, toys and childcare articles in the Philippines.
FDA Registration in the Philippines
An individual or entity that seeks to import, export, manufacture, distribute, sell, offer for sale, transfer, promote, market, advertise or sponsor products, such as food products, food supplements, drugs, medical devices, pesticides, hazardous substances, toys, and childcare articles, in the Philippines must first obtain a License to Operate (LTO) from the Food and Drug Administration (FDA) as an importer, manufacturer, distributor or wholesaler.
Subsequently, depending on the product, each product must likewise be registered or notified with the FDA.
De Leon IP Law Firm can assist you in applying for an LTO, and securing a Certificate of Product Registration (CPR) or Certificate of Product Notification (CPN) for your products in the Philippines. Our lawyers will help you obtain the right registrations for your products and assist you on how to be compliant with the requirements of the FDA every step of the way.