How to Apply for an LTO: Requirements, Inspection and 20 Working Days

1. Key takeaways

An LTO is applied for through the FDA eServices portal. The file includes company registration documents, financial proof and a Risk Management Plan (RMP); a manufacturer must additionally hold a Site Master File (SMF), and the process includes a pre-licensing inspection. The published processing time is 20 working days on the medical device manufacturer track. From 1 January 2026 the List of Sources and Authorized Suppliers or Clients and the Contract of Agreement become mandatory requirements.

• Route: eServices portal submission, not paper filing.
• Two-track review: documentary evaluation plus an on-site inspection by FROO, which cannot be waived.
• Corporate scope: the articles of incorporation must expressly cover the activity being licensed.
• New threshold: the source list and the supporting contracts are now part of the licence file, which shifts the burden onto real trading relationships.
• Fee: the current schedule remains AO No. 50 s. 2001, tiered by assets and subject to the 1 percent LRF.

2. Legal basis

The licensing rules were consolidated in a 2024 administrative order that repealed the previous 2020 order. The documentary checklist is published separately as an annex to an FDA advisory, which is where applicants should verify the current list before filing.

3. Expert insights

First insight: approval runs on two tracks, documents and premises, and the inspection cannot be avoided. The sequence is fixed: submission through the eServices portal, payment, then an FROO inspection that results either in a certificate of compliance or in a non-recommendation, followed by central evaluation, quality assurance review and a decision by the centre director. The inspection is not a formality inserted between two desk reviews. It verifies whether the premises match the declared address, whether the GPS coordinates are accurate, whether storage conditions meet the declared standard, whether the qualified person is actually present, and whether documents can be produced on the spot rather than promised for later. Applicants who prepare only the dossier and neglect the site visit lose the most time, because a non-recommendation restarts the cycle.

Second insight: the corporate registration documents must state the business scope. AO No. 2024-0015 requires the SEC certificate of registration and the articles of incorporation, and the articles must state the health product activities being applied for, such as manufacture or distribution covering import, export and wholesale. This is a common sticking point. Philippine companies often have articles drafted either far too broadly or far too narrowly relative to the activity being licensed, and the FDA will require an amendment before the application can proceed. The amendment itself is an administrative process with its own timeline, so the scope clause should be checked at the start of the project rather than after the file has been lodged.

Third insight: the two mandatory items from 1 January 2026 raise the bar for the whole licensing system. The list of sources and authorised suppliers or clients must identify supplier names, addresses and the product list by category, and must distinguish local from imported sources. The basis for determining the LTO activity type is a legally binding contract between the establishment and its clients or suppliers. In practice this means that both initial applications and renewals must be supported by real commercial contracts, not declarations of intent. The space available to a shell holding entity with no operating relationships is correspondingly narrowed, and holders that have been used purely as certificate vehicles will find renewal harder than first issuance.

Fourth insight: financial documents are substantively verified, and under-declaration is treated as a false statement. The file must include the latest audited financial statements, or proof of initial capital where the entity is newly formed. The FDA states expressly that submitted documents will be verified during inspection and throughout the life of the LTO, and that any finding of under-declaration will be regarded as a false statement and will constitute grounds for regulatory action. This matters beyond the licence itself: because validity periods and fee tiers are both keyed to enterprise size, the declared asset position determines the duration of the licence and the amount payable, and a misstatement therefore contaminates two separate determinations at once.

4. Practical recommendations

• Check the business scope in the articles of incorporation before applying. Confirm that the activity type to be licensed is stated, and amend first where it is not.
• Prepare the premises file. GPS coordinates, floor plan, lease contract where the site is not owned, and the mayor permit where the address differs from the registered address.
• Manage the source list and contracts as routine records. Keep a supplier and client contract register so that applications and renewals draw on documents that already exist.
• Declare financial information accurately. Avoid any under-declaration, which the FDA treats as a false statement rather than a clerical error.
• Verify the qualified person against Annex C. Enter the name and qualifications in the eServices application form, and make sure the person can attend the inspection.

5. Verification checklist

• □ Current rules confirmed as AO No. 2024-0015
• □ Corporate registration documents present, being the SEC, DTI or CDA certificate plus articles stating the licensed activity
• □ Financial documents prepared, either audited statements or proof of initial capital
• □ Risk Management Plan drafted and available
• □ Site Master File prepared for a manufacturer and producible at inspection
• □ Source list and contract of agreement in place, mandatory from 1 January 2026
• □ Qualified person checked against Annex C, with name and qualification entered in eServices
• □ Processing time of 20 working days understood on the manufacturer track

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com