FDA licensing & compliance

FDA registration in the Philippines, start to shelf

Most consumer goods cannot be sold here until the FDA has licensed the business behind them and cleared the product itself. We file both, keep them from lapsing, and work out which ones your category actually needs before you spend anything. Handled from our Makati office.

  • We tell you which licences your category needs before you commit
  • New LTO in 30–40 working days, product registration in 20–30
  • Renewals filed ahead of expiry, so the licence never lapses

Or call 0917 631 8876 — Mondays to Fridays.

Book a consultation

Tell us what you are bringing to market. We will tell you which licences apply.

No obligation. We reply from our Makati office.

Established 2018

Philippine compliance practice

20+ years

Combined regulatory experience

Makati office

Filings handled locally

EN · FIL · 中文

Work in your language

Product categories

Which products the FDA regulates

Find yours below to see which certificate it runs through. Whichever one applies, the establishment License to Operate still has to come first.

FDA · CPR

Food and beverage

Packaged food and drinks, registered per product with the FDA. Food registrations can run up to five years.

FDA · CPR

Food supplements

Registered per product in the same way as food, but the certificate runs two years rather than five.

FDA · CPR

Drug products

Over-the-counter and prescription medicines, registered per product behind a drug-establishment licence.

FDA · CPN

Cosmetics & personal care

Skincare, haircare, makeup and toiletries, cleared through notification rather than full registration.

FDA · CMDN / CMDR / IVDR

Medical devices

Notified or registered through the FDA's device route, with the certificate depending on the device class.

FDA · CPR

Household and urban hazardous

Cleaners, detergents and similar chemicals, registered as household or urban hazardous products.

Not everything is FDA territory. Electrical, electronic and construction goods answer to the Bureau of Philippine Standards instead — the PS Mark, or an ICC clearance shipment by shipment. Fuel, energy and environmentally regulated products may answer to the DOE or the DENR. Those are ours as well — see which agency covers what.

What we file

Every FDA approval your product needs, with the time it takes

These are our working turnarounds, not best cases. The establishment licence comes first in every path — product registration cannot be filed without it.

Selling something the FDA does not cover — electrical, construction, energy or environmentally regulated goods? See which agency certifies what.

How it works

Four steps, in the order the FDA requires them

  1. Scope your category

    We confirm which licences your product actually needs — and whether anything outside the FDA applies.

  2. License to Operate

    We prepare and file the establishment licence, including the facility requirements behind it.

  3. Register each product

    CPR or CPN per product and per variant, filed once the LTO is active.

  4. Keep it current

    Renewals filed ahead of expiry, variations handled when your details change.

What Our Clients Say

Trusted by businesses across industries throughout the Philippines.

Questions we get

FDA compliance, answered

Do we need a License to Operate before registering a product?

Yes. The LTO licenses the establishment, not the product, and it has to be in place before any Certificate of Product Registration or Cosmetic Product Notification can be filed. It is the first step for anyone bringing food, drug, cosmetic or medical device products to market.

What is the difference between a CPR and a CPN?

A Certificate of Product Registration covers food, drugs, supplements and household hazardous products. A Cosmetic Product Notification covers cosmetics — skincare, haircare, makeup and personal care. The CPN is notification-based rather than a full registration, but it still requires a valid cosmetic-establishment LTO.

Does every product variant need its own registration?

Yes. Products with different variants, flavours, dosage forms or packaging sizes are each registered separately and each receive their own FDA registration number. Ten flavours means ten CPRs.

How long does FDA registration take?

A new LTO application runs 30 to 40 working days. A Certificate of Product Registration takes 20 to 30 working days, and a Cosmetic Product Notification 15 to 20 working days. LTO renewals and variations take 2 to 3 months because they include a facility inspection.

How long do the certificates stay valid?

CPR validity is 2 years for supplements and 5 years for food products. A CPN is valid for 1 year and renews annually. LTO renewal has to be filed before the existing licence expires.

What happens if our LTO lapses?

Operating with an expired LTO can result in establishment closure, product recall and administrative sanctions. This is why renewal is filed ahead of expiry rather than after it.

We sell through a local distributor — who holds the licence?

The establishment that handles the product needs the LTO. For cosmetics in particular, a foreign brand selling through a local distributor has to make sure that distributor holds a valid cosmetic-establishment LTO before any notification is filed.

Do you provide the pharmacist the FDA requires?

Yes. We provide an outsourced pharmacist for FDA compliance, typically arranged within 3 to 5 working days, for establishments that need one to satisfy their licensing conditions.

Is the FDA the only agency we need to deal with?

Not always. Electrical, electronic and construction products need the DTI Philippine Standard (PS) Mark from the Bureau of Philippine Standards, and petroleum, energy or environmentally regulated goods may need DOE or DENR certification. Our product certification page sets out which agency covers what.

Tell us what you are bringing to market

Send the product category and where you are in the process. We will come back with the licences that apply, the order they have to be filed in, and how long each one realistically takes.

Book a consultation

Tell us what you are bringing to market. We will tell you which licences apply.

No obligation. We reply from our Makati office.