Product Registration · FDA Registration
FDA registration in the Philippines
Food, drugs, cosmetics and medical devices authorized by the Philippine FDA, with dossiers prepared to the standard each FDA center expects.
Overview
Two layers of FDA authorization
The Food and Drug Administration regulates food, drugs, cosmetics, medical devices and household urban hazardous substances under the Food and Drug Administration Act of 2009 (RA 9711). Before any product is authorized, the company must hold a License to Operate in the right capacity, such as importer, distributor or manufacturer. Each product then needs its own authorization, evaluated by the FDA center responsible for its category.
The route differs by category. Food and drug products are issued Certificates of Product Registration through the Center for Food Regulation and Research and the Center for Drug Regulation and Research. Cosmetics follow ASEAN cosmetic notification under the center for cosmetics and household urban hazardous substances, and medical devices are registered or notified according to their risk classification. We confirm the exact pathway and dossier for your product.
What we handle
Authorization for every regulated category
The right license first, then each product through the right center.
License to Operate
Your company's LTO as importer, distributor or manufacturer secured before products are filed.
Food and drugs
Certificate of Product Registration applications prepared for the responsible FDA center.
Cosmetics
ASEAN cosmetic notifications filed with ingredient and labeling review.
Medical devices
Registration or notification by risk classification, with a technical file to match.
How it works
How registration works
Four stages in the order the FDA requires.
Classification
Your product’s category, FDA center and authorization route confirmed.
License to Operate
The company LTO filed in the correct capacity, or your existing license checked.
Dossier
The technical file assembled to the standards of the responsible center.
Filing and follow-through
The application or notification filed and FDA evaluation queries answered.
Estimated timeline
90 days from the signing of the engagement
Timelines are estimates and depend on complete documents and government agency processing.
Why register with ILA
Right route first
Classification settled before you spend on a dossier.
Center-ready files
Dossiers built to what each FDA center actually checks.
Renewals tracked
Licenses and product authorizations kept current after approval.
Frequently asked questions
FDA registration questions, answered
Which FDA center handles my product?
It depends on the category: food, drugs, cosmetics and household urban hazardous substances, and medical devices each have their own center. Borderline products, such as supplements or items carrying health claims, need careful classification because the route changes the requirements. We confirm the classification for your case before anything is filed.
Do I need a License to Operate before registering products?
Yes. The company must first hold an LTO in the right capacity, such as importer or distributor, and each product is then authorized under it. If you sell through a local distributor, we advise on who should hold the license and the product authorizations.
Is a foreign approval accepted in the Philippines?
Approvals from other countries do not replace FDA authorization, although supporting documents from the manufacturer or the country of origin often form part of the dossier. We confirm which documents your product needs.
Ready to register your product with the FDA?
Book a free consultation and we will confirm your product’s classification and registration path.
