FDA Registration Services

FDA Registration Services in the Philippines

Foreign investors and enterprises that intend to do business in the Food, Pharmaceutical or Cosmeceutical industries in the Philippines are required to register their products with the Food and Drug Administration (FDA). The registration requirements and processing timelines depend on the classification of the products to be marketed, which could be any of the following:

  • food;
  • food supplements;
  • drugs;
  • cosmetics;
  • household hazardous;
  • pesticides;
  • medical devices;
  • diagnostics; or
  • veterinary products.

Before these products can be imported, exported, distributed, marketed, advertised or manufactured in and out of the Philippines, a foreign investor or company must first secure a License to Operate (LTO) from the FDA as: (1) Importer, Distributor or Wholesaler if their products are going to be imported from different countries; or as (2) Manufacturer if their products are going to be manufactured locally.

After obtaining an LTO, they must apply for a Certificate of Product Registration (CPR) to have their products examined and officially registered with the FDA. Product licensing and certification from the FDA is required by law under Republic Act No. 10611 and is strictly regulated.

The FDA is tasked to regulate the production, sale, and traffic of products allowed entry into the Philippine market to protect public health and safety, and it is important to secure LTO and CPR from this agency not only to comply with Philippine laws but also to increase the credibility of your product/s through the assurance of food safety and ethical practice in the medical trade.

Our FDA registration experts will help you obtain the right type of licenses for your product/s and will work with appropriate government agencies to help you stay on top of rules and regulations imposed by the FDA on regulated products in the Philippines.

Need Assistance in Registering Your Products in the Philippines?

With K&C, you get a dedicated one-stop solution for your product registration and FDA licensing needs.