Which Establishments Now Require an FDA LTO Under AO No. 2024-0015

August 11, 2025

Starting January 2025, new rules from the Philippine FDA will expand the list of businesses required to secure a License to Operate (LTO). These changes might apply to you if you’re in healthcare, manufacturing, logistics, or tech-enabled services. Here’s what you need to know about AO No. 2024-0015 and how it could impact your business.

What Is an FDA License to Operate (LTO)?

In the Philippines, a License to Operate (LTO) issued by the Food and Drug Administration (FDA) is a mandatory requirement for any establishment involved in manufacturing, importing, exporting, distributing, or selling health-related products. This includes food, drugs, cosmetics, medical devices, and household hazardous substances.

The LTO serves as proof that a business meets regulatory standards for safety, efficacy, and quality. Without this license, companies cannot legally operate within FDA-regulated industries. Businesses in these sectors that operate without an LTO risk penalties, suspension, or even closure.

Overview of AO No. 2024-0015

Administrative Order (AO) No. 2024-0015, officially titled “Revised Guidelines on the Licensing of Establishments Engaged in FDA-Regulated Products,” was issued to update and consolidate the licensing rules for FDA-regulated businesses. Now in effect as of 2025, this order replaces AO 2020-0017 and introduces significant changes to the list of establishments that require an LTO.

The main objective of AO 2024-0015 is to address technological advancements, close regulatory gaps, and clarify industry roles. Businesses involved in digital fabrication, diagnostic testing, and component manufacturing are now brought under the scope of FDA licensing, effectively clarifying that certain sectors require an FDA LTO.

Expanded List of Establishments That Now Require an LTO

One of the most notable changes under AO 2024-0015 is the expanded coverage of businesses that now need an FDA LTO. These include:

Dental laboratories – whether they produce dentures, crowns, or orthodontic appliances, dental labs are now classified as medical device manufacturers.
Optical laboratories – establishments involved in grinding, edging, or coating prescription lenses must now secure an LTO.
3D printing facilities – businesses using 3D printing to create medical device components or health products (e.g., custom implants or prosthetics) now fall under FDA oversight.
Home test kit assemblers – establishments assembling diagnostic kits or repackaging test kits are now considered manufacturers or repackers.
Cold chain storage and logistics providers – third-party logistics firms handling temperature-sensitive FDA-regulated products must now apply for an LTO.

This expansion aligns the FDA’s regulatory net with emerging technologies and global health standards.

Clarified Definitions of Manufacturing and Distribution

AO 2024-0015 also clarifies the definitions of key business functions like manufacturing, distribution, and trading.

Manufacturing now includes assembly, re-labeling, re-packaging, 3D printing, and refurbishment. Due to expanded criteria, businesses previously considered outside the manufacturing category may now fall under it.
Distribution is broadly defined as logistics providers, e-commerce fulfillment centers, and even digital platforms that handle regulated products.
The AO also clarifies the difference between a trader and a distributor. Traders import or outsource the manufacture of products under their name, while distributors handle storage and delivery without altering the product.

These revised definitions aim to eliminate loopholes and ensure that all parts of the supply chain meet FDA standards.

Do These Changes Apply to Your Business?

If your business falls into any of the newly specified categories or your operations now fit the broader definitions of manufacturing or distribution, you may now be required to secure an FDA LTO, even if you didn’t need one before.

Ask yourself:

Do you assemble, customize, or 3D print medical or health-related products?
Are you involved in storing or transporting regulated goods like medicines, test kits, or devices?
Do you repackage or re-label FDA-regulated products before selling them?

If the answer to any of these is yes, your business is likely now covered under AO 2024-0015.

How to Apply for an FDA LTO for Medical Establishments

To apply for a License to Operate (LTO) for medical-related businesses, follow these general steps:

Create an FDA ePortal Account – Register at www.fda.gov.ph and activate your account.
Prepare Required Documents – These typically include your business registration (SEC/DTI), occupancy permit, site master file (for manufacturers), full product list with descriptions, and other company-specific documents. Requirements for medical-related businesses are typically stricter and often require on-site inspections.
Submit Online Application – Log in to the FDA eServices portal and complete the LTO application form. Upload your documents and pay the applicable fees.
Wait for FDA Evaluation – The FDA will review your application, which may include site inspections for certain categories.
Receive Your LTO – If approved, your LTO will be issued electronically and will be valid for up to 2 years (renewable).

The FDA LTO application process is stringent. Ensure your requirements are complete, accurate, and compliant to avoid complications, delays, or license denial.

Final Thoughts

AO 2024-0015 significantly shifts the FDA’s regulatory landscape. The government aims to uphold higher safety standards across a rapidly evolving health products sector by broadening and clarifying the scope of businesses that require a License to Operate. If you’re unsure about your compliance status, now is the time to act. Contact Triple i Consulting, and we’ll help determine if you need an LTO and assist you throughout the application process.

Are You Applying for or Renewing an FDA License to Operate?

Applying for or renewing an FDA License to Operate (LTO) in the Philippines can be a time-consuming and detailed process. With strict documentation requirements, deadlines, and platform changes, it’s easy to make a mistake or miss a step, leading to penalties or delays in your operations.

That’s where Triple i Consulting comes in. Our team of experienced lawyers and accountants provides comprehensive support for your business, so you don’t have to stress over the paperwork.

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Call us at: +63 (02) 8540-9623
Send an email to: info@tripleiconsulting.com

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