Product Certification
Product Certification in the Philippines
Product certification in the Philippines is essential for businesses that want to legally distribute and sell regulated products in the country. Many products must comply with the standards set by government agencies and other regulatory authorities.
Whether you are introducing a new product to the Philippine market or ensuring compliance with national standards, we guide you through the entire certification process—from documentation to approval.
The Philippine Food and Drug Administration (FDA) is responsible for licensing, monitoring, and regulating health products that will be manufactured, imported, distributed, sold, or promoted in the Philippine market—specifically:
Food (including processed/prepackaged food and food supplements)
Drugs / Pharmaceutical products
Cosmetics
Medical devices
Biologicals and vaccines
In-vitro diagnostic (IVD) reagents/devices (laboratory test kits/reagents)
Household/Urban Hazardous Substances (HUHS) (certain regulated chemicals/consumer hazardous products)
This definition of “health products” is reflected in the FDA Act of 2009 (RA 9711).
License to Operate (LTO) Application
A License to Operate (LTO) is the FDA’s official approval that allows a company to legally manufacture, import, distribute, sell, or market FDA-regulated products in the Philippines. It’s usually the first requirement before product registration.
Who needs it?
Any business handling regulated “health products” such as food, drugs, cosmetics, medical devices, and selected hazardous household products must secure an LTO to operate compliantly.
LTO types (based on your role):
Importer
Distributor / Wholesaler
Manufacturer
What happens after LTO?
Once your LTO is approved, you may proceed to the correct product authorization, depending on your product category:
CPR (Certificate of Product Registration) – Prior to applying for a Certificate of Product Registration (CPR), your company must first secure a valid License to Operate (LTO). Each product intended for market distribution must be registered separately, taking into account its specific variant, formulation, or dosage strength. Upon approval, every product will be assigned its own unique registration number.
Medical Device Authorization – CMDN / CMDR / IVDR: Registering a medical device with the Food and Drug Administration (FDA) confirms that it complies with the safety, quality, and performance standards required for distribution in the Philippine market. To proceed with the registration of any medical device category, the company must first obtain a valid License to Operate (LTO) from the FDA.
Cosmetic Product Notification (CPN) Application
A Cosmetic Product Notification (CPN) is similar to a Certificate of Product Registration (CPR) in that it also requires a valid License to Operate (LTO). However, while the CPR covers various product categories such as food and pharmaceutical products, the CPN specifically applies to businesses involved in the manufacture, importation, or distribution of cosmetic products.
What We Do:
Our team of experienced FDA specialists provides comprehensive assistance throughout the regulatory process, including product registration, classification, investigational device submissions, and preparation of licensing documentation. We support businesses in securing the following FDA approvals and certifications:
License to Operate (LTO)
Certificate of Product Registration (CPR)
Cosmetic Product Notification (CPN)
Certificate of Medical Device Notification (CDMN)
Certificate of Medical Device Registration (CDMR)
In-Vitro Diagnostic Device Registration (IVDR)
License to Operate Variations (Major and Minor Amendments)
Product Registration Variations (for Drugs, Food, and Medical Devices)
In addition to obtaining FDA licenses, we also assist with the renewal of licenses and permits, as well as ensuring that your production facilities comply with the FDA’s regulatory standards and operational requirements.