Product Certification

Regulatory overview

FDA Registration in the Philippines

The Philippines' growing consumer market offers significant opportunities in manufacturing, importation, distribution, and retail. But before any regulated health product can enter the market, it must comply with the requirements of the Food and Drug Administration (FDA).

The Food and Drug Administration (FDA) of the Philippines is the primary government agency responsible for ensuring the safety, quality, and efficacy of health-related products — including food, drugs, cosmetics, medical devices, and household hazardous products. All businesses handling these products must comply with FDA requirements at two distinct levels: the establishment and the product.

Level 1 — Establishment

The business or facility handling regulated products must secure a License to Operate (LTO) from the FDA before any product may be commercially introduced or distributed.

Level 2 — Product

Each individual product must also be separately registered or notified with the FDA under the appropriate certificate — CPR, CMDN, CMDR, IVDR, or CPN — depending on its classification.

Who needs to comply

Any business engaged in the following activities involving regulated health products in the Philippines must meet FDA requirements.

• Manufacturing

• Importation

• Exportation

• Distribution & Sale

• Promotion & Advertising

• Transfer of goods

Registration types

Licenses and certificates we handle

Each regulated product category requires a specific FDA certification. Below are the registrations our team manages on your behalf.

License to Operate (LTO)

Mandatory first step · All regulated establishments · Importer, Distributor, Wholesaler, or Manufacturer

Required first

An LTO is the foundational FDA certification that authorizes a business to operate within the Philippine regulated health product space. It must be secured before any product registration or notification can be filed. Foreign entities must obtain an LTO before introducing any product to the Philippine market.

Documentary requirements

• Accomplished FDA application form

• Proof of business registration (SEC, DTI, or equivalent)

• Site Master File (required for manufacturers of drugs, devices, and cosmetics)

• Risk Management Plan

• Proof of payment of applicable FDA fees

Certificate of Product Registration (CPR)

Foods · Drugs · Food supplements · Household/Urban hazardous products

Per Product

A CPR is required for each individual product a business intends to sell or distribute in the Philippines. Products with multiple variants, dosage forms, or packaging sizes must be registered individually — each receiving its own unique registration number. An active LTO is a prerequisite before any CPR application may be filed.

Documentary requirements

• Accomplished FDA application form

• Complete loose labels or artwork for all packaging sizes

• Product photographs from all angles

• Justification of label claims — nutritional facts, Halal logo, health claims (if applicable)

• Product sample in actual commercial presentation (for food supplements)

• Proof of payment of applicable FDA fees
  

Medical Device & In-Vitro Diagnostic Certification

CMDN · CMDR · IVDR — based on device risk classification

By Classification

Medical devices and in-vitro diagnostic devices are classified by risk level, which determines the specific certification required — CMDN (notification), CMDR (registration), or IVDR. All categories require an active LTO prior to application. Registration ensures that the device meets Philippine safety, efficacy, and quality standards before entering the market.

Documentary requirements

• Accomplished FDA application form

• Complete loose labels or artwork of the device packaging

• Product photographs from all angles

• Certificate of Analysis from the manufacturer

• Proof of payment of applicable FDA fees

Cosmetic Product Notification (CPN)

Cosmetic products only · Per product notification · LTO required

Cosmetics only

The CPN is the FDA certification specific to cosmetic products. While it follows a similar process to the CPR, it carries distinct technical requirements — particularly around ingredient disclosure and manufacturer documentation. An active LTO for a cosmetic establishment is mandatory before filing any CPN.

Documentary requirements

• Certificate of Manufacturer from the producing establishment

• Certificate of Free Sale or Good Manufacturing Practice (GMP) Certificate

• Full ingredient list — names, functions, and percentage of each ingredient in the formulation

• Complete loose labels and artworks for all packaging sizes and commercial presentation

• Proof of payment of applicable FDA fees

Validity periods

How long are FDA licenses and certificates valid?

FDA licenses and product registrations are time-bound and must be renewed upon expiration. Validity periods vary by product classification and establishment type.

What we offer

End-to-end FDA registration assistance

Our FDA consultants manage the full registration process — from initial classification advisory through to license issuance, variation filings, and renewal management.

• License to Operate (LTO) — initial application and renewal

• Certificate of Product Registration (CPR) — food, drugs, hazardous products

• Cosmetic Product Notification (CPN)

• CMDN / CMDR / IVDR — medical devices and in-vitro diagnostics

• Variation of LTO — major and minor amendments

• Variation of Product Registration — drugs, food, and medical devices

• License and permit renewal management

• Production facility compliance with FDA specifications

Bringing a product to the Philippine market?

Our FDA consultants will assess your product classification, identify the correct licenses and certifications required, and manage the entire registration process — so your products reach the market compliantly and without unnecessary delays.