How to Get a Medical License to Operate from the Philippine FDA

August 14, 2025

Suppose your business deals with medicines, medical devices, cosmetics, or other health-related products in the Philippines. In that case, you must secure a Medical License to Operate (LTO) from the Food and Drug Administration (FDA). This license proves your establishment complies with the government’s safety and regulatory standards.

Read more to learn what a Medical LTO is, who needs one, and the updated application process now in effect as of November 2024.

What Is a Medical LTO?

A Medical LTO is an official document issued by the Philippine FDA granting your business the legal authority to manufacture, import, distribute, wholesale, or retail regulated health products.

The “medical” designation applies when your operations involve products such as:

Prescription and over-the-counter drugs
Medical devices and equipment
Food supplements and vitamins
Cosmetics and personal care products

This license differs from a local Business Permit (also called Mayor’s Permit) from your city or municipality. It specifically relates to compliance with national health product regulations.

Who Needs an FDA Medical LTO in the Philippines?

You must obtain an FDA-issued Medical LTO if your establishment is engaged in any of the following:

Manufacturing medicines, medical devices, or cosmetics – Includes producing products locally for sale, whether for mass-market distribution or niche medical use.
Importing or exporting regulated health products – Covers bringing products into or out of the country, even in bulk shipments for distribution.
Wholesale or distribution of pharmaceuticals and medical supplies – Applies to businesses supplying products to hospitals, clinics, pharmacies, or other retailers.
Operating a pharmacy, drugstore, or retail outlet selling regulated products – Includes both stand-alone stores and those inside larger establishments.
Operating online platforms that sell FDA-regulated items – Encompasses e-commerce sites, social media sellers, and online marketplaces offering health products.

AO 2024-0015, in effect since November 2024, also released 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.

Even online businesses without a physical store need an LTO if they sell regulated products. Failure to secure one can result in fines, closure orders, and goods confiscation.

Requirements for a Medical LTO Application

The requirements vary depending on your specific business type, but for medical retailers and pharmacies, you’ll need:

FDA e-Portal Account – Register your business and upload your documents online.
Petition Form & Affidavit – Notarized, fully accomplished, no erasures.
Proof of Business Registration (DTI/SEC) – DTI for sole proprietors; SEC papers for corporations/partnerships; include Secretary’s Certificate if needed.
Local Business Permit – Valid Business Permit (also called Mayor’s Permit) with the exact registered business name and address.
Franchise Documents – Franchise agreement and proof of franchisor’s registration, if applicable.
Pharmacist Requirements – Board certificate, PRC ID, PTR, duties list, and FDA-accredited seminar certificates.
List of Products – Include both generic and brand names.
Proof of Premises – Notarized lease contract, proof of ownership, or Certificate of Occupancy.
HOA Clearance – If applicable to the location.
Establishment Photo – Front exterior also showing registered business name.
Location Plan – Location sketch with landmarks and floor plan with dimensions.
Licensing Fee – A fixed fee plus an additional fee to cover the inspection costs.

Importers, exporters, wholesalers, vendors of medical devices, and other medical-related businesses may require additional documentation. Certain establishments may also undergo strict inspections and laboratory tests before being granted a Medical LTO.

To avoid complications, delays, and license denial, make sure your required documents are complete, accurate, and fully compliant.

Step-by-Step Process to Apply for an FDA Medical LTO

The FDA now processes all LTO applications online through its e-Portal System, following the AO 2024-0015’s policies. Here’s how the process works:

Create an FDA e-Portal Account
- Register your business details and nominate an authorized representative.
Prepare Your Requirements
- Scan all documents in PDF format. Make sure they are clear and signed when necessary.
Submit Your Application Online
- Log in to the FDA e-Portal and select the correct application type (new, renewal, or variation). Upload your documents and fill out the online forms.
Pay the Corresponding Fees
- The system will generate an Order of Payment. Settle this through the FDA’s accredited payment channels.
On-site inspections (if applicable)
- Typically, these are conducted for manufacturers to verify that facilities meet Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), or other relevant standards.
Laboratory testing (if applicable)
- Normally for manufacturers, this is performed to confirm that products meet safety, quality, and efficacy requirements before approval or market release.
Additional steps (if applicable)
- Additional steps may be required depending on your business.
Wait for FDA Review
- The FDA will evaluate your application and may request clarifications or additional documents.
Receive Your Medical LTO
- If approved, you can download your form from the e-Portal. It is recommended that you print and display it at your place of business.

While online applications are convenient, direct assistance from the FDA remains limited. Contact Triple i Consulting to ensure your required documents are complete, accurate, and fully compliant. We will guide you through the entire process, streamlining your application while avoiding complications and delays.

How to Renew or Update Your Medical LTO

A Medical LTO is usually valid for around two years. Renewal should be filed at least 90 days before expiration to avoid penalties or business disruptions.

For renewal:

Log in to the FDA e-Portal.
Choose “Renewal” and upload updated documents. The requirements are similar to the application requirements but are more streamlined.
Pay the renewal fee and await processing.

Be sure to update the FDA on any major changes to your business, such as a change in address, business name, qualified personnel, or the range of products handled.

Final Thoughts

Securing a Medical LTO from the Philippine FDA is a legal requirement for any business dealing with regulated health products. Prepare your documents early, use the FDA e-Portal, and renew on time to ensure uninterrupted operations and maintain compliance with national health regulations. Contact Triple i Consulting if you have any inquiries or need expert assistance for your application.

Are You Applying for a Medical LTO from the FDA?

Applying for or renewing a Medical License to Operate (LTO) in the Philippines can be a time-consuming and detailed process. With strict documentation requirements, inspections, and even laboratory tests, 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.

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

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