Philippines LTO: License to Operate for Device Establishments

1. Key takeaways

The LTO, or License to Operate, is the establishment licence that the FDA issues to local Philippine companies engaged in manufacturing, importing, exporting, wholesale distribution, retail and related device activities. It is a prerequisite for filing a CMDN or CMDR, not an alternative to it. The current rules are set by DOH Administrative Order No. 2024-0015 of November 2024, which has replaced AO No. 2020-0017.

The sequencing is deliberate. The Philippine system requires an accountable legal person before it will consider a product: the establishment obtains an LTO, and only then can it submit a product application. Neither element substitutes for the other, and a product file submitted by an entity without a valid LTO is returned regardless of its technical quality. This is why the first verification step in any Philippine project is the status of the local partner rather than the content of the dossier.

• LTO is an establishment licence held by a Philippine entity, not by the overseas manufacturer.
• AO No. 2024-0015 of November 2024 governs and has replaced AO No. 2020-0017.
• Operating without an LTO is prohibited by Section 11(k) of RA 9711.
• During the fee suspension, AO No. 50 s. 2001 applies, with manufacturer fees of PHP 5,000, 7,000 or 10,000 by asset tier plus the one percent LRF.
• From 1 January 2026 the List of Sources and Authorized Suppliers or Clients and the Contract of Agreement become mandatory documents.

2. Legal basis

The order covers all health product establishments within its scope, and its formal title is instructive because it also states the repeal explicitly. The requirement sits under RA No. 9711 and its implementing rules and regulations, and the prohibition on operating without a licence is a statutory one rather than a creation of the administrative order.

3. Expert insights

Insight one: the LTO and the product certificate are two independent tracks.

The design principle is that the entity comes before the product. An establishment obtains its LTO and then files the CMDN or CMDR. The most frequent blockage we encounter is a client that has selected the product and completed the technical file, only to find that the Philippine partner holds an expired LTO or one whose activity scope does not cover device importation. The application is returned at intake, and the work done on the dossier does not shorten the wait for the partner to correct its licence.

Insight two: the activity type on the LTO must match the commercial role exactly.

Under AO No. 2024-0015 the LTO is divided by activity: manufacturer, including packer and repacker; distributor, including importer, exporter and wholesaler; trader; retailer; and operator of a medical waste treatment facility, among others. Documentary requirements change with the activity. A manufacturer must submit a Site Master File (SMF), and both manufacturers and distributors must submit a Risk Management Plan (RMP). The point we watch most closely is that the scope of activity stated on the licence matches what the company actually does. A mismatch surfaces later, at import clearance and at tender qualification, where the licence is read by a different authority for a different purpose.

Insight three: two documentary requirements become mandatory in 2026.

According to the FDA explanation of the LTO documentary checklist in Annex A of FDA Advisory No. 2025-0512, the list of sources and authorised clients and the contract of agreement become mandatory from 1 January 2026 under the transitional arrangements of AO No. 2024-0015. This is the compliance milestone most likely to be missed in 2026, because it is a documentary obligation rather than a technical one. At renewal or variation, an establishment that cannot produce contracts with its suppliers and clients has no evidential basis for the scope of activity claimed on the licence.

Insight four: an overseas manufacturer cannot hold an LTO, and that shapes the whole holding structure.

An LTO is issued only to a Philippine entity. An overseas manufacturer therefore cannot hold one and cannot file a product application in its own name. That single design feature determines that market entry must run through a local entity, and it makes the question of who holds the certificate the central commercial decision rather than a downstream administrative choice.

4. Practical recommendations

• Run an LTO health check before any product filing. Verify the licence number, expiry date, stated activity types and the name of the qualified person, and retain a scanned copy on file. Verification through the FDA Verification Portal should be repeated close to the submission date, since a licence can lapse between partner selection and filing.
• Bring the 1 January 2026 documents into routine management. Maintain a register of supplier and client contracts so that every LTO can be traced to an actual contractual relationship. Treat the register as a living document, updated whenever a distributor or supplier changes.
• Manage LTO validity by establishment size. Validity differs with the size of the establishment, and renewal should be scheduled six months ahead so that any documentary gap can be closed without interrupting supply.

5. Verification checklist

• □ Confirm the current LTO rules against AO No. 2024-0015, which has replaced AO 2020-0017.
• □ Confirm the LTO number and expiry date through the FDA Verification Portal or the QR code on the certificate.
• □ Confirm that the activity types stated on the certificate cover the actual operations.
• □ Confirm that the qualified person is in post against the qualification requirements in Annex C of the certificate.
• □ Confirm the 2026 mandatory documents: the list of sources and the contract of agreement.
• □ Confirm the fee schedule in force: AO No. 50 s. 2001 plus the one percent LRF.

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